Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4801 | [14C]-radiolabelled BI 1358894 Wiki | 0.26 |
| drug4178 | Suboxone Wiki | 0.26 |
| drug3026 | PEAR-008 Wiki | 0.26 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug496 | BI 1358894 Wiki | 0.26 |
| drug2549 | Medication Assisted Treatment Wiki | 0.26 |
| drug4132 | Standard therapy for TUD Wiki | 0.26 |
| drug3349 | PrEP Wiki | 0.26 |
| drug4125 | Standard smoking cessation therapy for TUD plus Chess-based cognitive treatment Wiki | 0.26 |
| drug738 | CBD Isolate Wiki | 0.26 |
| drug1719 | Full Spectrum CBD Oil Wiki | 0.26 |
| drug2702 | MyPath tool Wiki | 0.26 |
| drug4595 | Usual Care plus Customized Referrals Wiki | 0.26 |
| drug492 | BGB DXP593 Wiki | 0.26 |
| drug2621 | Mindful Self-Compassion Wiki | 0.26 |
| drug4073 | Standard Dissemination Practice Wiki | 0.26 |
| drug4130 | Standard therapy for AUD plus Chess-based cognitive treatment Wiki | 0.26 |
| drug4754 | Woebot Substance Use Disorder Wiki | 0.26 |
| drug4294 | Team Intervention Wiki | 0.26 |
| drug3230 | Placebo Oil Wiki | 0.26 |
| drug5179 | reSET-O Wiki | 0.26 |
| drug4129 | Standard therapy for AUD Wiki | 0.26 |
| drug2644 | Mobile Enhanced Prevention Support Wiki | 0.26 |
| drug2094 | Implementation Facilitation (IF) Wiki | 0.26 |
| drug493 | BGB-DXP593 Wiki | 0.26 |
| drug4109 | Standard of Care Treatment Wiki | 0.18 |
| drug896 | Camostat Mesilate Wiki | 0.17 |
| drug3195 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000437 | Alcoholism NIH | 0.27 |
| D012749 | Sexually Transmitted Diseases NIH | 0.26 |
| D009293 | Opioid-Related Disorders NIH | 0.26 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D015231 | Sexually Transmitted Diseases, Bacterial NIH | 0.26 |
| D016739 | Behavior, Addictive NIH | 0.26 |
| D015775 | Fractures, Stress NIH | 0.18 |
| D006526 | Hepatitis C NIH | 0.15 |
| D014029 | Tobacco Use Disorder NIH | 0.13 |
| D004194 | Disease NIH | 0.12 |
| D020920 | Dyssomnias NIH | 0.10 |
| D020447 | Parasomnias NIH | 0.09 |
| D040921 | Stress Disorders, Traumatic NIH | 0.04 |
| D004630 | Emergencies NIH | 0.04 |
| D014947 | Wounds and Injuries NIH | 0.04 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.04 |
Navigate: Correlations HPO
There are 15 clinical trials
Background: - Drugs of abuse have effects on mood, behavior, thinking, and decision making that may encourage people to continue using them and make it difficult for them to stop. Researchers who study these effects are interested in developing new tests to evaluate how drugs and drug use affect different areas of the brain. - Magnetic resonance imaging (MRI) scans allow researchers to study brain activity and changes to brain function. When specific psychological tests are performed during functional MRI (fMRI) scans, researchers can examine the effects of drug use on the brain. By developing and testing new procedures for fMRI studies, more information can be obtained on brain function and activity in drug-using and non-drug-using individuals, and this information can help develop new treatments and therapies for substance abuse. Objectives: - To evaluate the effects of newly developed psychological procedures to be performed during fMRI scans. Eligibility: - Healthy volunteers between 13 and 55 years of age who are willing to undergo MRI scanning. - Both drug-using and non-drug-using individuals will be selected for this study. Design: - Before the start of the study, participants will complete questionnaires about medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed during the scanning session(s), and will allow participants to practice the test either on a separate computer or on the computer used during the MRI scan. - During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks will be performed on a computer in an MRI machine, and may involve receiving rewards (such as money or sips of juice) for actions, memory and reaction-time tests, or other tests that involve responding to instructions on the screen. - Participants will receive compensation for their participation in the study, including hourly compensation for individual visits and lump-sum compensation for each MRI scan.
Description: yield measurable and interpretable fMRI results, and/or if they are able to be combined with the application of tDCS
Measure: To determine if the tasks reliably and appropriately measure specific cognitive constructs and behaviors thought to be associated with specific brain systems and, also if they yield measurable and interpretable fMRI results. Time: each visitThe purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.
Description: The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT over the 12 month period.
Measure: Implementation (Considered the Primary Outcome) Time: 12 monthsDescription: The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.
Measure: Effectiveness Time: 30 Days Post EnrollmentDescription: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
Measure: Implementation: Fidelity Time: Baseline Period (Baseline)Description: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
Measure: Implementation: Fidelity Time: IF Evaluation Period (18 months)Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Measure: Implementation: ED provider Readiness and Preparedness Ruler Score Time: Pre IF (Baseline)Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Measure: Implementation: ED provider Readiness and Preparedness Ruler Score Time: Post IF (6 months)Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Measure: Implementation: ED provider Readiness and Preparedness Ruler Score Time: post IF Evaluation Period (12 months)Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Time: Pre IF (Baseline)Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Time: Post IF (6 months)Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Time: Post IF Evaluation Period (12 months)Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community Readiness and Preparedness Ruler Score Time: Pre IF (Baseline)Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community Readiness and Preparedness Ruler Score Time: Post IF (6 months)Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community Readiness and Preparedness Ruler Score Time: post IF Evaluation Period (12 months)Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community ORCA Score Time: Pre IF (Baseline)Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community ORCA Score Time: Post IF (6 months)Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community ORCA Score Time: post IF Evaluation Period (12 months)Description: Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days
Measure: Effectiveness: Opioid Use Time: 30 days post enrollmentDescription: Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records
Measure: Effectiveness: Overdose Event Time: 30 days post enrollmentDescription: HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale
Measure: Effectiveness: HIV Risk Time: 30 days post enrollmentDescription: All Healthcare Service Utilization Inpatient and Outpatient
Measure: Effectiveness: Healthcare Service Utilization Time: 30 days post enrollmentDescription: Rates of illicit opioid negative urines
Measure: Effectiveness: Illicit Opioid Urine Toxicology Time: 30 days post enrollmentVeterans with co-occurring Posttraumatic Stress Disorder and Substance Use Disorder (PTSD-SUD) experience more severe symptomatology and poorer response to existing treatments than Veterans with either disorder alone. Guilt is a common posttraumatic reaction and has been implicated as a risk factor for the development and maintenance of PTSD and substance use. Combat Veterans often report experiencing moral injury defined as perpetrating, failing to prevent, or witnessing acts that violate the values they live by in their civilian lives, which can lead to feelings of guilt and shame. Accordingly, reduction in guilt and increase in self-compassion may lead to improved quality of life for Veterans. This project will conduct a pilot study to evaluate changes in self-compassion, guilt, and PTSD-SUD symptom severity in a sample of Veterans after receiving 8 sessions of Mindful Self Compassion treatment (via a telehealth modality during COVID-19 pandemic). Findings will have significant impact on effective treatment options and lead to improvements in Veterans' quality of life and posttraumatic symptoms.
Description: The SCS is a 26-item self-report questionnaire in which respondents describe how they relate to themselves during times of distress. The SCS includes the 5 item Self-Kindness subscale (ranging from 5-25; higher scores reflect more self-kindness), the 5-item Self-Judgment subscale (ranging from 5-25; higher scores reflect more self-judgment), the 4-item Common Humanity subscale (ranging from 4-20; higher scores reflect higher levels of common humanity), the 4-item Isolation subscale (ranging from 4-20; higher scores indicate higher levels of isolation), the 4-item Mindfulness subscale (ranging from 4-20; higher scores reflect higher levels of mindfulness) and the 4-item Over-Identification subscale (ranging from 4-20). Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." Mean scores on the six subscales are then averaged to create an overall self-compassion score ranging from 26 to 130. Higher scores correspond to higher levels of self-compassion.
Measure: Self-Compassion Scale (SCS); Change from baseline in Self-Compassion at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeksDescription: The TRGI is a 32-item validated self-report measure assessing traumatic guilt. The TRGI has three scales - Guilt Severity, Distress, and Guilt Cognitions. In all 32 items the answers are recorded on 5-point scale (ranging from 0 - not at all true to 4 - extremely true). Eight items are reverse-scored. We will use the TRGI as one of our eligibility criteria and to monitor changes in guilt and related cognitions over time.
Measure: Trauma-Related Guilt Inventory (TRGI); Change from baseline in trauma-related guilt at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeksDescription: The ISS is a 30-item self-report measure assessing shame proneness scored on a 5-point Likert scale ranging from 0 = "never" to 4 = "almost always". The ISS yields sum scores for two subscales, self-esteem (6 items; range = 0-24 with higher scores reflecting higher levels of self-esteem) and internalized shame (24 items; range = 0-96 with higher scores reflecting higher levels of shame) and has been well-validated with research and clinical populations. The self-esteem items are interspersed to counteract a negative response set.
Measure: Internalized Shame Scale (ISS); Change from baseline in shame at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeksDescription: The CAPS is a semi-structured interview used to assess PTSD diagnostic criteria and severity. Respondents select up to three of the most traumatic events they have experienced, and those events are used as the basis for assessing PTSD symptoms. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-40). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20).
Measure: Clinician Administered PTSD Scale for DSM-5; Change from baseline in PTSD symptoms at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeksDescription: The WHO-QOL BREF is a 26-item validated self-report measure that that assesses quality of life across four domains: physical (7 items, range 1-5), psychological (6 items, range 1-5), social relationships (3 items, range 1-5), and environment (8 items, range 1-5). The four domain scores denote an individual's perception of quality of life in each particular domain. The mean score of items within each domain is used to calculate the domain score. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life on a scale of 1 - "very poor" to 5 - "very good". Question 2 asks about an individual's overall perception of their health on a scale of 1 - "very dissatisfied" to 5 - "very satisfied". The WHO-QOL-BREF has excellent internal validity and test-retest reliability.
Measure: Quality Of Life Enjoyment & Satisfaction Questionnaire (WHO-QOL-BREF); Change from baseline in quality of life at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeksDescription: The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. The TLFB will be employed at all three assessment points to evaluate alcohol and other substance use during the 90 days preceding each interview. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB will be used at each follow-up to establish: percentage days heavy drinking, percent days abstinent, length of initial abstinence, length of use episodes, severity of relapse and current alcohol/drug use pattern. The Alcohol TLFB has been shown to have good psychometric characteristics with a variety of groups, and can generate variables that provide a wide range of information about an individual's use (e.g., pattern, variability, and magnitude of use).
Measure: Timeline Follow-back; Change from baseline in frequency of substance use at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeksDescription: Beck Scale for Suicidal Ideation (BSSI): This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week before evaluation (19). Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38 with higher score indicating more risk for suicide.
Measure: Beck Scale for Suicidal Ideation; Change from baseline in suicidal risk at post-treatment (2 mo) and follow up (3mo) Time: Baseline, 8-10 weeks, 12-14 weeksThis study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail, living in a residential facility providing substance use services or supportive housing . The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.
Description: Defined as the participant identifying and completing an appointment with a primary care provider who is willing and able to prescribe HIV pre-exposure prophylaxis. Provide documentation of the appointment.
Measure: Number of participants establishing a primary care provider who can prescribe PrEP (pre-exposure prophylaxis) Time: 9 monthsDescription: Defined as the participant completing the screening process for PrEP with an eligible provider or PrEP navigator. Provide documentation of the appointment.
Measure: Number of participants obtaining screening for PrEP Time: 9 monthsDescription: Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication
Measure: Number of participants who initiate PrEP regimen Time: 9 monthsDescription: Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week over the prior 30 days
Measure: Number of participants who demonstrate minimal adherence to PrEP Time: 30 daysDescription: The participant will provide documentation of filled PrEP prescriptions for 3 or more months
Measure: Number of participants who remain on PrEP for at least 3 months. Time: 3 monthsDescription: Defined as the participant self-reporting having obtained HIV testing every 3 months over the 12 month follow-up period
Measure: Number of participants who undergo a HIV test every 3 months Time: 9 monthsDescription: Defined by the participant self-reporting having obtained testing for these 3 bacterial sexually transmitted diseases (STDs) every 6 months over the 12 month follow-up period
Measure: Number of participants who undergo a test for gonorrhea, syphilis, and chlamydia every 6 months Time: 9 monthsDescription: Defined by the participant self-reporting having obtained at least one test for Hepatitis C
Measure: Number of participants who undergo a test for hepatitis C Time: 9 monthsDescription: Defined by the participant self-report of completing initial recommended SUD appointments within 3 months of jail release, consistent with each participant's recommended American Society of Addiction Medicine (ASAM) level of care
Measure: Number of participants obtaining treatment for substance use disorders (SUDs) in the community Time: 3 monthsDescription: Defined by the participant self-reporting remaining engaged in treatment (i.e., continuing to attend meetings, counseling or other treatment activities) as defined by the recommended ASAM level of care in the 3 months prior to each follow-up interview.
Measure: Number of participants who remain engaged in treatment for substance use disorders (SUDs) in the community, Time: 3 monthsDescription: Self-report of whether or not participants received follow-up care and treatment for HIV, STD, and hepatitis C infections diagnosed during study follow-up (n=300)
Measure: Number of participants in each arm receiving care and treatment for newly diagnosed HIV or STD infections. Time: 9 monthsDescription: Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=300), quantified as the number of respondents who are reincarcerated and the total number of reincarcerations per arm over the study period.
Measure: Number of participants in each arm experiencing recidivism Time: 9 monthsDescription: Describe the temporal distribution of PrEP uptake and supportive social service utilization patterns of the participants in the MEPS intervention arm using data collected via the GeoPassport mobile app (n=150).
Measure: Temporal service utilization patterns of intervention arm participants Time: 9 monthsDescription: Report the geographic distribution of PrEP uptake and supportive social service utilization patterns of the participants in the MEPS intervention arm using data collected via the GeoPassport mobile app (n=150).
Measure: Geographic service utilization patterns of intervention arm participants Time: 9 monthsNeurobiological and neuropsychological approaches to investigate the potential mechanism of action of chess as an add-on therapy (chess based - cognitive remediation treatment, CB-CRT) to reduce cognitive deficits in individuals with alcohol use disorder (AUD).
Description: fMRI cue-reactivity task (Vollstädt-Klein et al. 2010)
Measure: change in neural cue-reactivity Time: 2 time points: before and after 6 weeks chess-based cognitive trainingDescription: fMRI sequential reinforcement-based task (Huys et al. 2012)
Measure: change in sequential reinforcement-based neural mechanisms Time: 2 time points: before and after 6 weeks chess-based cognitive trainingDescription: fMRI stop-signal task (Whelan et al. 2012)
Measure: change in neural correlates of inhibition Time: 2 time points: before and after 6 weeks chess-based cognitive trainingDescription: self-report
Measure: substance use (alcohol consumption and tabacco use) Time: 3 months follow-up after the end of treatmentDescription: fMRI spatial working memory task (Vollstädt-Klein et al. 2010)
Measure: change in neural working memory processes Time: 2 time points: before and after 6 weeks chess-based cognitive trainingDescription: working memory capacity measured by letter-number sequencing task of the [Wechsler Memory Scale (Kent 2013)]; raw values will be transformed to IQ-like scales (mean 100, SD 15); the higher the value, the higher the working memory capacity
Measure: Change in working memory capacity Time: 3 time points: before and after 6 weeks SCP plus after 3 monthsDescription: One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Measure: Change in planning ability Time: 3 time points: before and after 6 weeks SCP plus after 3 monthsDescription: Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Measure: Change in cognitive flexibility Time: 3 time points: before and after 6 weeks SCP plus after 3 monthsDescription: impulsivity measured with BIS scale [Barratt impulsiveness scale (Patton et al. 1995)];range 15-60; total score will be used; high values represent high impulsivity
Measure: Change in impulsivity Time: 3 time points: before and after 6 weeks SCP plus after 3 monthsDescription: [Iowa Gambling Task (Bechara et al. 1994)]
Measure: Change in decision-making Time: 3 time points: before and after 6 weeks SCP plus after 3 monthsDescription: [Reversal learning task (Vanes et al. 2014)]
Measure: Change in mental flexibility Time: 3 time points: before and after 6 weeks SCP plus after 3 monthsDescription: [d2 Test of Attention (Brickenkamp 2002)].
Measure: Change in attentional capacity Time: 3 time points: before and after 6 weeks SCP plus after 3 monthsDescription: [measured with fMRI]
Measure: change in functional connectivity within the salience network (SN) and executive control network (ECN) Time: 2 time points: before and after 6 weeks therapy and chess-based cognitive trainingThe principal aim of this study is to determine whether a novel biopsychosocial intervention following opioid overdose (OD) affects 1) the frequency of secondary opioid OD events and 2) the proportion of individuals who remain engaged in treatment for opioid use disorder (OUD) or are in remission at 30 days and at 180 days post intervention. Remission is defined as engagement in daily medication-assisted therapy (MAT)-typically buprenorphine/naloxone (BUP) or methadone- and/or a recovery capital score of ≥ 27.5. The intervention principally involves connecting OUD-affected individuals with community resources, including BUP-, MAT-, and education-related services. To carry out the intervention, an addiction recovery coach and an appropriately trained health-educator paramedic (research assistant) will form a team and perform follow-up visits (electronically/remotely and/or by phone) after a participant has experienced at least 1 opioid OD requiring naloxone resuscitation. Our hypothesis is that the intervention will decrease subsequent OD events and increase the likelihood of remission. To evaluate this hypothesis, data will be collected from self-report and from EPIC, Yale New Haven Hospital's medical record system. The secondary aim is to determine whether the intervention affects 1) the frequency of positive-urine tests for opioids and 2) the frequency and proportion of subjects self-reporting opioid use. Our hypothesis is that our intervention will decrease both. Data from the entire cohort will be compared in aggregate with patients who were started on BUP in the ED over the same time period and with historic controls.
Description: Frequency of positive urine tests at 30 days after intervention (data obtained via chart review)
Measure: Frequency of positive urine tests at 30 days (chart review) Time: 30 days post interventionDescription: Frequency of positive urine tests at 180 days after intervention (data obtained via chart review)
Measure: Frequency of positive urine tests at 180 days (chart review) Time: 180 days post interventionDescription: Frequency of positive urine tests at 30 days after intervention (data obtained via self-report)
Measure: Frequency of positive urine tests at 30 days (self-report) Time: 30 days post interventionDescription: Frequency of positive urine tests at 180 days after intervention (data obtained via self-report)
Measure: Frequency of positive urine tests at 180 days (self-report) Time: 180 days post interventionDescription: Percentage of positive urine tests at 30 days after intervention (data obtained via chart review)
Measure: Percentage of positive urine tests at 30 days (chart review) Time: 30 days post interventionDescription: Percentage of positive urine tests at 180 days after intervention (data obtained via chart review)
Measure: Percentage of positive urine tests at 180 days (chart review) Time: 180 days post interventionDescription: Percentage of positive urine tests at 30 days after intervention (data obtained via chart review)
Measure: Percentage of positive urine tests at 30 days (self-report) Time: 30 days post interventionDescription: Percentage of positive urine tests at 180 days after intervention (data obtained via self-report)
Measure: Percentage of positive urine tests at 180 days (self-report) Time: 180 days post interventionThe current context of the Covid-19 health crisis leads to an over-solicitation of health systems, with hospital staff in the front line. These personnel are undergoing high levels of stress, an alteration of their life rhythm, but also of their health status and quality of life at work. In addition, night work, through the disruption of circadian rhythms, has consequences on physical and mental health. The more frequent worsening of the condition of certain patients at night increases the burden and responsibilities of night staff. Increasing the use of psychoactive substances (SPAs) can become a solution for managing stress, work rhythms, sleep disorders and their consequences. This self-medication behaviour is not without risks, neither for staff nor for patients. The ALADDIN study is a project made up of 2 waves of questionnaires - one during and the other after the Covid "hospital" crisis - filled in by the hospital night staff of AP-HP. This project will assess the impact of the Covid-19 epidemic on the quality of work life, mental health disorders, post-traumatic stress and substance use of hospital night staff. The main objectives of this study is to evaluate the prevalence of psychoactive substance consumption among the night shift healthcare workers of the AP-HP and to describe the participants' quality of working life. Methods The study is prospective study using an online self-completed questionnaire. The questionnaire was elaborated on the basis of the validated scales ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test), AUDIT-C (Alcohol Use Disorder Test, shortened version) and HAD (for anxiety and depression) and on qualitative interviews conducted among care staff working the night shift. The questionnaire will be completed at t0 (baseline) and 18 months after. This study will provide data on the consumption psychoactive substances by night hospital workers adn their quality of working life. It will also allow us to compare their consumption with the general population, and to describe the risk factors influencing the consumption.
Description: Prevalence in APHP health workers of psychoactive substance consumption during the Covid 19 outbreak
Measure: Substance use prevalence Time: at T0 month : baselineDescription: Evaluation of the quality of working life during the Covid 19 outbreak using a validated scale
Measure: Quality of working life scale Time: at T0 month : baselineDescription: Identify the preferences for intervention to improve the quality of life or change the addictive risk of night hospital staff at the APHP. Preferences for intervention methods and ranking of the least preferred.
Measure: Intervention preference Time: at T0 monthDescription: Describe the risk factors associated with the consumption of psychoactive substances (PAS). Logistic or fish linear regression depending on the type of variable taken into account.
Measure: Psychoactive substance consumption and associated factors Time: at T0 monthDescription: Evaluate the impact of substance use on quality of life at work Principal component analysis and classification to see if there are consumer groups for the night and / or day population. Method for taking into account missing, unused or invalid data
Measure: Impact of substance consumption on quality of life at work Time: at T0 monthDescription: Describe the risk factors associated with tobacco use among night hospital workers,
Measure: Risk factors associated with tobacco use Time: at T0 monthDescription: Evaluate the impact of sleep quality on the quality of working life and perceived health of night staff
Measure: Impact of sleep quality on quality of working life and perceived health Time: at T0 monthDescription: Describe the links between QWL and sleep, anxiety, depressive syndromes, and workplace upheaval.
Measure: Impact of anxiety and depressive symptoms on sleep and QWL. Time: at T0 monthDescription: Describe the links between anxiety/depressive syndromes and workplace disruption, sleep, and the Covid epidemic.
Measure: Impact of sleep and workplace upheaval on anxiety and depressives symptoms Time: at T monthDescription: Comparison between the baseline score and prevalences and the score and prevalences 18 months after
Measure: Modification of quality of working life score and psychoactive substances consumption prevalences Time: T18 monthsDescription: Analysis of the relation between declared change and evolution of the quality of life score
Measure: Comparison of modification of quality of life score and declared quality of life modification after 18 month Time: T18 monthsThe current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction. The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users
Description: measurement of the difference in drugs consumption caused by containment (delta)
Measure: Evolution of consumption Time: 1 dayDescription: measurement of the difference in drugs consumption caused by containment (delta)
Measure: Evolution of consumption Time: 1 month after confinmantDescription: number of drug users referred to care (%)
Measure: health care access Time: 1 dayDescription: number of drug users referred to care (%)
Measure: health care access Time: 1 month after confinmantThis study seeks to gather data and insight on epidemiologic trends of loneliness and other behaviors in the wake of the CDC recommended "social distancing" during the COVID-19 pandemic. The objective of this study is to use a cross-sectional survey to assess the impact of COVID-19's associated recommendations (social distancing, self-isolation, and self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety, substance abuse) on young adults (18-35 years old).
Description: University of California Los Angeles ( UCLA) Loneliness Scale is a 20-item self-report questionnaire that evaluates subjective feelings of loneliness and social isolation. Participants rate items on a 4-point Likert scale ranging from 1 (never) to 4 (often).Items are summed to create a score that can range from 20-80, higher scores being indicative of greater loneliness.
Measure: Loneliness as evaluated by the UCLA loneliness scale Time: Day 1Description: Alcohol Use Disorder Identification Test (AUDIT) is a 10-item self-reported questionnaire used to identify individuals whose alcohol consumption could be hazardous for their health. Participants rate items in a 5-point Likert scale, indicating amount (0 to 10 drinks or more), frequency (never to daily or almost daily), and indication of problems caused by alcohol (yes or no). Items were summed up to create a score that can range from 0 to 50. A score of 1 to 7 indicates low risk consumption, whereas a score of 8-15 suggests risky or hazardous drinking, a score of more than 15 is likely to indicate high-risk drinking and alcohol dependence.
Measure: Alcohol Use as evaluated by the AUDIT Time: Day 1Description: The Drug Abuse Screening Test (DAST-10) is a 10-item self-reported screening test that provides a quantitative index of the degree of consequences related to drug abuse. Participants rate items yes or no, positive responses corresponding to 1 point. Items are summed up to create a score that can range from 0-10. A score of 1-2 represents risky behaviors related to drugs, 3-5 represents moderate problems, 6-8 represents substantial problems, and 9-10 represents severe problems.
Measure: Drug Use as evaluated by the DAST-10 Time: Day 1Description: The General Anxiety Disorder Scale (GAD- 7) is a 7- item self-reported screening tool that assess presence and severity of Generalized Anxiety Disorder. Participants rated frequency of problems in a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed up to create a score with scores of 5, 10, and 15 being the cut-off points for mild, moderate and severe anxiety, respectively.
Measure: Anxiety as evaluated by GAD-7 Time: Day 1Description: The Center for Epidemiologic Studies Depression scale (CES-D-10) is a 10-item self-reported measure that assesses the frequency of symptoms of depression. Participants rate frequency of symptoms in a 4-point Likert scale from 0 (rare or none of the time) to 3 (most or almost all the time). Items are summed up to create a score that ranges from 0 to 30, with higher scores representing greater depressive symptoms. A score of 16 or more represents clinical depression.
Measure: Depression as assessed by CES-D-10 Time: Day 1The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic. This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.
Description: Range from 0-100 (no pain to worst pain imaginable)
Measure: Pain rating Time: Difference between baseline and post-treatment (8 weeks from baseline)Description: Total score between 0-27, higher scores indicate greater levels of depression
Measure: Patient Health Questionnaire-9 (PHQ-9) Time: Difference between baseline and post-treatment (8 weeks from baseline)Description: Total score between 0-21, higher scores indicate greater levels of anxiety
Measure: General Anxiety Disorder-7 (GAD-7) Time: Difference between baseline and post-treatment (8 weeks from baseline)Description: Range from 8 to 32, with higher values indicating higher satisfaction
Measure: Client Satisfaction Questionnaire (CSQ) Time: Post-treatment (8 weeks from baseline)The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program. The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.
Description: Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Measure: Proportion who demonstrate no or minimal opioid use. Time: 3 monthsDescription: Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Measure: Proportion who demonstrate no or minimal opioid use. Time: 6 monthsDescription: Measured via negative HIV test.
Measure: Proportion who remain HIV negative. Time: 3 monthsDescription: Measured via negative HIV test.
Measure: Proportion who remain HIV negative. Time: 6 monthsDescription: Defined as the proportion who remain on treatment (MOUD or PrEP).
Measure: Persistence in care Time: 3 monthsDescription: Defined as the proportion who remain on treatment (MOUD or PrEP).
Measure: Persistence in care Time: 6 monthsDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Measure: Ease/difficulty of visiting a SSP to meet with a provider via telemedicine Time: 1 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant over time (qualitative method)
Measure: Ease/difficulty of visiting a SSP to meet with a provider via telemedicine Time: 6 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Measure: Ease/difficulty of accessing the telemedicine video platform Time: 1 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Measure: Perceptions of medical care quality via a telemedicine video platform Time: 6 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Measure: Participant satisfaction with the program Time: 1 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Measure: Participant satisfaction with the program Time: 6 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Measure: Participant perceived usefulness of the program Time: 1 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Measure: Participant perceived usefulness of the program Time: 6 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Measure: Motivators and barriers affecting program persistence Time: 6 monthDescription: Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Measure: Motivators and barriers affecting medication adherence and persistence Time: 6 monthThe purpose of this study is to evaluate how patients use and engage with a game-based mobile application that is designed to treat opioid use disorder.
Description: Evaluate the number of active sessions per week between PEAR-008 and reSET-O
Measure: Evaluate Participant Engagement Data Time: From Week 1 to Week 8 (End of Treatment)Description: Evaluate if PEAR-008 increases retention in treatment compared to reSET-O by comparing drop-out rates
Measure: Evaluate Treatment Retention Based on Drop-Out Rates Time: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Evaluate if PEAR-008 increases abstinence compared to reSET-O, as measured by saliva drug screens, urine drug screens and self-reporting
Measure: Evaluate Illicit Drug Abstinence Time: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Evaluate participants' digital therapeutic use patterns based on usage data collected, comparing PEAR-008 to reSET-O
Measure: Evaluate Digital Therapeutic Use Patterns Based on Usage Data Time: From Week 1 to Week 8 (End of Treatment)Description: Assess the effect of PEAR-008 and reSET-O on depressive symptoms using the eight-item Patient Health Questionnaire (PHQ-8) scores from Baseline to End of Treatment and Follow-up. The PHQ's total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Measure: Assess Effect on Depressive Symptoms Time: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Assess the effect of PEAR-008 and reSET-O on anxiety symptoms using the Generalized Anxiety Disorder-7's (GAD-7) scores from Baseline to End of Treatment and Follow-up. The GAD-7's total score ranges from 0 (not clinically significant) to 21 (clinically significant)
Measure: Assess Effect on Anxiety Symptoms Time: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Assess the effect of PEAR-008 and reSET-O on recovery capital using the ten-item Brief Assessment of Recovery Capital (BARC-10) scores from Baseline to End of Treatment and Follow-up. The BARC-10's total score ranges from 10 to 60
Measure: Assess Effect on Recovery Capital Time: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Summarize participant satisfaction surveys and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics
Measure: Describe Participant Satisfaction Surveys Time: Baseline, Week 4, Week 8 (End of Treatment)Description: Summarize participant satisfaction interviews and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics
Measure: Describe Participant Satisfaction Interviews Time: Week 12 (Follow-up)Description: Assess the impact of the COVID-19 pandemic on participants using the five-item Council on American-Islamic Relations (CAIR) Pandemic Impact Questionnaire (C-PIQ) scores from Baseline to End of Treatment and Follow-up. The C-PIQ's total score ranges from 0 to 20
Measure: Assess Coronavirus Disease (COVID-19) Impact Time: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Assess the effect of the COVID-19 pandemic on depressive symptoms using the COPE: Coronavirus Perinatal Experiences - Impact Survey (COPE-IS) (MODIFIED) scores from Baseline to End of Treatment and Follow-up. Participants will be asked how they are coping with stress during COVID-19 from a list of responses. There is no scoring for this measure
Measure: Assess Coronavirus Disease (COVID-19) Impact on Stress Time: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Assess the effect of PEAR-008 and reSET-O on resilience using the 10-item Connor-Davidson Resilience Scale 10 (CD-RISC-10) scores from Baseline to End of Treatment and Follow-up. The CD-RISC-10 is a 10-item self-rating scale using a 5-point Likert scale ranging from "not true at all" to "true nearly all of the time"
Measure: Assess Effect on Resilience Time: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Evaluate the correlation between engagement (daily and weekly participant use patterns of PEAR-008 and reSET-O) and treatment outcomes (abstinence and retention in treatment)
Measure: Evaluate Engagement and Efficacy Relationship Time: From Week 1 to Week 8 (End of Treatment), Week 12 (Follow-up)Description: Assess the effect of PEAR-008 and reSET-O on changes in skill acquisition using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) from Baseline to End of Treatment. The CBTSQ measures two factors: Behavioral Activation (BA) and Cognitive Restructuring (CR). BA factor scores range from 0 to 35, and higher scores indicate greater use of BA skills. CR factor scores range from 0 to 45, and higher scores indicate greater use of CR skills
Measure: Change in Skill Acquisition Time: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)Description: Assess the effect of PEAR-008 and reSET-O on medication adherence rates using findings from saliva drug screens and urine drug screens
Measure: Medication Adherence Rates Time: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)The overarching objective of the proposed project is to test the relative clinical efficacy of CBD isolate, full-spectrum CBD oil, and placebo in in reducing COVID-Induced stress, anxiety, depression, anger, and sleep disturbance.
Description: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 0-BaselineDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 1-TreatmentDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 2-TreatmentDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 3-TreatmentDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Weeks 4-TreatmentDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 5-TreatmentDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 6-TreatmentDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 7-Follow-upDescription: This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Emotional Distress Index Time: Week 8-Follow-upDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Depression Scale Time: Week 0-BaselineDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Depression Scale Time: Week 1-TreatmentDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Depression Scale Time: Week 2-TreatmentDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Depression Scale Time: Week 3-TreatmentDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Depression Scale Time: Week 4-TreatmentDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Depression Scale Time: Week 5-Follow-upDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Depression Scale Time: Week 6-Follow-upDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anxiety Scale Time: Week 0 BaselineDescription: This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anxiety Scale Time: Week 1-TreatmentDescription: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anxiety Scale Time: Week 2-TreatmentDescription: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anxiety Scale Time: Week 3-TreatmentDescription: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anxiety Scale Time: Week 4-TreatmentDescription: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anxiety Scale Time: Week 5-Follow-upDescription: This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anxiety Scale Time: Week 6-Follow-upDescription: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anger Scale Time: Week 0 BaselineDescription: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anger Scale Time: Week 1 TreatmentDescription: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anger Scale Time: Week 2 TreatmentDescription: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anger Scale Time: Week 3 TreatmentDescription: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anger Scale Time: Week 4 TreatmentDescription: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anger Scale Time: Week 5 Follow-upDescription: This measure is an 8-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Anger Scale Time: Week 6 Follow-upDescription: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Alcohol Negative Consequences Scale Time: Week 0 BaselineDescription: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Alcohol Negative Consequences Scale Time: Week 1 TreatmentDescription: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Alcohol Negative Consequences Scale Time: Week 2 TreatmentDescription: This measure is an 8-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).
Measure: PROMIS Alcohol Negative Consequences Scale Time: Week 3 TreatmentDescription: This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).
Measure: PROMIS Alcohol Negative Consequences Scale Time: Week 4 TreatmentDescription: This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).
Measure: PROMIS Alcohol Negative Consequences Scale Time: Week 5 Follow-upDescription: This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).
Measure: PROMIS Alcohol Negative Consequences Scale Time: Week 6 Follow-upDescription: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).
Measure: PROMIS Sleep Disturbance Scale Time: Week 0 BaselineDescription: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).
Measure: PROMIS Sleep Disturbance Scale Time: Week 1 TreatmentDescription: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).
Measure: PROMIS Sleep Disturbance Scale Time: Week 2 TreatmentDescription: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).
Measure: PROMIS Sleep Disturbance Scale Time: Week 3 TreatmentDescription: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).
Measure: PROMIS Sleep Disturbance Scale Time: Week 4 TreatmentDescription: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).
Measure: PROMIS Sleep Disturbance Scale Time: Week 5 Follow-upDescription: This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).
Measure: PROMIS Sleep Disturbance Scale Time: Week 6 Follow-upDescription: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measure: COVID-19 Coping Self-Efficacy Time: Week 0 BaselineDescription: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measure: COVID-19 Coping Self-Efficacy Time: Week 1 TreatmentDescription: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measure: COVID-19 Coping Self-Efficacy Time: Week 2 TreatmentDescription: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measure: COVID-19 Coping Self-Efficacy Time: Week 3 TreatmentDescription: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measure: COVID-19 Coping Self-Efficacy Time: Week 4 TreatmentDescription: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measure: COVID-19 Coping Self-Efficacy Time: Week 5 Follow-upDescription: This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measure: COVID-19 Coping Self-Efficacy Time: Week 6 Follow-upThis is a pilot study to evaluate the acceptability and feasibility of incorporating a patient-facing reproductive decision support tool, MyPath, into existing clinical pathways in a SUD treatment program. This study will be conducted virtually in partnership with a single substance use treatment program within the University of Pittsburgh Medical Center (UPMC). Aim 1: Assess the feasibility and acceptability of incorporating a patient-facing reproductive decision support tool (MyPath) into existing clinical pathways in a substance use treatment program. Aim 2: Assess preliminary efficacy of MyPath on reproductive health knowledge, self-efficacy, and decisional conflict as compared to usual care, as well comparisons between receipt of reproductive health services during the usual care period versus after implementing the intervention. The investigators hypothesize that the MyPath tool is acceptable and feasible for participants and their providers within a SUD treatment program. They also anticipate that preliminary efficacy data will show a positive correlation between the MyPath intervention and receipt of reproductive services, as well as increased knowledge and self-efficacy with decreased decision conflict. This pilot study will lay the groundwork for future larger trials in order to measure efficacy of this tool in substance use treatment settings.
Description: Number of participants that report they are somewhat satisfied or very satisfied with reproductive discussions as assessed on a Likert scale from 1 (very dissatisfied) to 5 (very satisfied)
Measure: Number of participants reporting satisfaction with reproductive discussions assessed by 5-point Likert scale Time: Approximately 2 weeksDescription: Number of providers that report they are comfortable or very comfortable with reproductive discussions as assessed on a Likert scale from 1 (very uncomfortable) to 5 (very comfortable)
Measure: Number of providers reporting comfort with reproductive discussions assessed by 5-point Likert scale Time: Approximately one monthDescription: Number of participants that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
Measure: Number of participants reporting satisfaction with MyPath assessed by 5-point Likert scale Time: Approximately 2 weeksDescription: Number of providers that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
Measure: Number of providers reporting satisfaction with MyPath assessed by 5-point Likert scale Time: Approximately one monthDescription: Likert scale Number of providers that report they agree or strongly agree with ease of incorporation statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
Measure: Number of providers reporting ease of incorporating MyPath into clinical workflow assessed by 5-point Likert scale Time: Approximately one monthDescription: Number of participants who enroll and complete all study procedures, including enrollment visit, pre- and post-surveys, and MyPath tool
Measure: Number of participants who complete all study procedures Time: Approximately six monthsDescription: Mean change in reproductive health knowledge defined as the difference in the number of correct responses to a set of reproductive health knowledge questions from surveys administered before and after the study visit
Measure: Mean change in reproductive health knowledge Time: Approximately one monthDescription: Mean change in self-efficacy, as assessed on a 5-point Likert scale from 1 (not confident at all) to 5 (very confident) by a set of self-efficacy statements from surveys administered before and after the study visit
Measure: Mean change in self-efficacy Time: Approximately one monthDescription: Mean change in decisional conflict, as assessed on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) by a set of decision statements from surveys administered before and after the study visit
Measure: Mean change in decisional conflict Time: Approximately one monthDescription: Number of participants who received reproductive health services as assessed by medical chart review at three month follow-up
Measure: Number of participants who received reproductive health services Time: Approximately four monthsHOMER is a national study comparing three methods of induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); home versus office versus telehealth-based inductions. This study will help determine if certain patient and practice characteristics make patients better candidates for one method over the others. Results will help fill a gap in the evidence around effectively treating OUD with MAT in primary care settings.
Description: Determined by prescription refills and patient self-report of number of days buprenorphine taken.
Measure: Number of days patient took buprenorphine Time: 270 daysDescription: Determined by a patient self-report of the number of days they took other opioids and urine opioid test results.
Measure: Number of days patient took illicit opioids Time: 270 daysDescription: Determined by initial prescription and refills, a patient self-report of number of days buprenorphine taken, and urine buprenorphine results.
Measure: Took buprenorphine on >80% of days Time: 270 daysDescription: Determined by a patient self-report of the numer of days they took other opioids and urine opioid test results.
Measure: Percent (%) of patients that took other opioids on <10% of days Time: 270 daysDescription: Patient surveys completed per clinical care on quality of life (e.g., symptoms, side effects, depression), social connectedness, loneliness, and other select determinants of health.
Measure: Social Determinant of Health and Quality of Life Time: 270 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports