|drug2054||Mindfulness Based Intervention Wiki||0.50|
|D011618||Psychotic Disorders NIH||0.20|
|D001523||Mental Disorders NIH||0.10|
|D013315||Stress, Psychological NIH||0.10|
There are 4 clinical trials
Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery. This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT). Cameo is a service for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their CAMEO team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study Time: Measure completed at baseline (start of week 1) and week 9.
Description: Social recovery will be measured using an adapted versions of the Time Use Survey (TUS) Structured Hours, which has been previously validated for use as a social recovery measure by Hodgekins, Fowler and colleagues, and utilised in the National EDEN study (Hodgekins et al. 2015; Hodgekins 2012; Fowler et al. 2009). This will be adapted to a reduced interview to include only those areas relevant to the social recovery measure, hence the Time Use Survey-Structured Hours (TUS-SH).Measure: Time Use Survey - Structured Hours (TUS-SH) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: PHQ-9 is a self-administered measure of depression, which scores all 9 of the DSM-IV criteria for depression. Scores range from 0-27, with 5-9 indicating minimal symptoms, 10-14 minor depression, 15-19 moderately severe major depression and ≥20 severe major depression.Measure: Patient Health Questionnaire (PHQ-9) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of sustained attention.Measure: Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of visual episodic memory.Measure: Paired Associates Learning (PAL) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of working memory and strategy.Measure: Spatial Working Memory (SWM) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: iPad delivered cognitive test of emotional recognition.Measure: Emotion Recognition Task (ERT) / CANTAB Cognitive Test Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: GAF is an assessment of psychological, social and occupational functioning along a hypothetical continuum of mental health/illness. It is suggested that symptom scale for degree of severity be considered to cover the past 3 days prior to assessment but time frames can be varied based on the intention of use (Aas 2011). However by utilising the split version of this measure, the symptom and function scores can be evaluated and considered independently. This has been shown to be highly consistent across experienced raters, so sufficient training and utilisation may be fundamental to its efficacy (Pedersen et al. 2007). Scores range from 0-100 with higher scores representing better functioning across symptomatic and functional domains (Hall 1995).Measure: Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S) Time: Measure completed in weeks 1, 9 and 17.
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17 Time: Measure completed at baseline (start of week 1) and week 17.
Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis Time: Measure completed at baseline (start of week 1) and week 5.
Description: SCI-8 this measure is validated against DSM-5 criteria for insomnia, including sleep quality and daytime function over the previous week. It is utilised within the Sleepio intervention and was the primary outcome measure for the OASIS randomised controlled trial (Freeman et al. 2017). This eight-item assessment questionnaire includes: 'concerns about getting to sleep, remaining asleep, sleep quality, daytime functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep'(Espie, Kyle, Hames, et al. 2014). It has a robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) (Espie, Kyle, Hames, et al. 2014). Scores range from 0-32 with higher scores indicating better sleep, scores below 17 identifying insomnia in 89% of cases (Espie, Kyle, Hames, et al. 2014; Freeman et al. 2017).Measure: Sleep Condition Indicator (SCI-8) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Description: ISI is a measure specifically designed as a brief self-administered measure of insomnia and outcomes for use in their treatment within research. It corresponds to the DSM-IV criteria for insomnia and measures perception and severity of symptoms within the previous 2 weeks. Scores range from 0-28, 0-7 indicating no significant insomnia, 8-14 sub threshold insomnia, 15-21 moderate clinical insomnia, and 22-28 severe clinical insomnia (Smith & Wegener 2003; Bastien et al. 2001). It has been validated as a web-based measure with internal consistency of ≥88% (Thorndike et al. 2011).Measure: Insomnia Severity Index (ISI) Time: Measure completed in weeks 1, 9 and 17.
Description: PSQI is a self-report 19-item measure that retrospectively measures sleep quality and disturbances over the previous month. The domains of sleep quality included are: sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems and impact on daytime function. Scores range from 0-21, with higher scores indicating poorer sleep quality. The empirically derived cut-off score is >5 to distinguish poor sleepers with severe difficulties in at least 2 domains, or moderate difficulties in more than 3 domains. This cut-off correctly identifies 88.5% of patients, with a sensitivity of 89.6% and specificity of 86.5% (Buysse et al. 1989; Smith & Wegener 2003).Measure: Pittsburgh Sleep Quality Index (PSQI) Time: Measure completed in weeks 1, 9 and 17.
Description: Nightly sleep diaries will be reported online using the Sleepio.com online diary. GENEActive actigraphy watch will collect raw data of activity. Which will record sleep patterns objectively. This will be compared with sleep diaries for consistency of subjective measure with objective measure. The actigraphy data will be considered for L5 (lowest 5 hours of activity) M10 (highest 10 hours of activity) and relative amplitude (ratio between L5 and M10). This will then be compared with the nightly sleep diaries for the same period to determine percentage of consistency of reporting.Measure: Validation of Sleep Diaries by comparison with actigraphy activity data Time: Monitoring will be done for a complete week just prior to week 1, during week 8 and 16. Sleep diaries are collected nightly during this same period.
Description: This is a short 7 question (3 minute) survey to allow us to collect basic data on the impact of the ongoing pandemic on participants.Measure: COVID-19 Brief Questionnaire (COVID-19-B) Time: Measure completed in weeks 1, 5, 9, 13 and 17.
Mindfulness training has been gaining popularity in the past decade as a means of improving general well-being. This trend appears in response to the new stressors that have arisen with the increased stress of the 21st century. Studies have shown that the psychological state of metacognitive awareness encapsulated in mindfulness can promote the decreasing of stress as well as the secondary effect of improving sleep quality; both outcome measures of this study. While the body of research evaluating these benefits is growing, there is limited emphasis placed on the individual differences that can affect the overall efficacy of mindfulness training. Our aim in this study is to observe the effects of mindfulness training on perceived stress levels as well as on sleep using subjective measures in a large sample of trainees. To achieve this, participants will be recruited from a pool of people who have signed up for a 4-week foundational mindfulness or 8-week mindfulness based stress reduction course at Brahm Centre. Questionnaires will be administered both before and after these courses to evaluate both stress levels and sleep habits as well as other factors which could contribute to the efficacy of mindfulness training. These inventories will probe the different facets of interpersonal differences that could serve to influence the effectiveness of the mindfulness intervention. In addition, the investigators will also test the effect of conducting the course online during a situation of emergency, like it is the partial lockdown that was implemented in Singapore due to the spread of Covid-19. The proposed study has the potential to provide new insights into the factors that affect the efficacy of mindfulness on stress and sleep, in a situation of non-emergency (until February the 6th 2020) as well as during a period of heightened restrictions (DORSCON Orange, from 7th of February to 6th of April 2020) and a partial lockdown (from 7th of April to 1st of June 2020, or until resume of normal activity). Further, the investigators hope to build an algorithm that can predict the potential effectiveness of mindfulness on a person by person basis. This could serve as a foundation for future recommendations for mindfulness training as well as open the door for future studies that could serve to further customize the mindfulness training framework to accommodate individual differences
Description: Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score above 5 suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep qualityMeasure: Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score Time: Up to one month
Description: The PSS measures whether different aspects of life were perceived as stressful by participants on a 5-point scale (where 0 was never and 4 was very often) in the past month. Positively worded questions are reversed scored and all 10 questions ratings are summarised into a total score, which ranges from 0 to 40, with higher scores indicating more perceived stress.Measure: Change in subjective measures of Stress: Perceived Stress Scale (PSS) Time: Up to one month
Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. This is the total perceived time in bed in minutes, calculated as item 3 of the PSQI ("When have you usually gotten up in the morning?") minus item 1 ("When have you usually gone to bed?")Measure: Change in Subjective Time in Bed (TIB) Time: Up to one month
Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. Total sleep time reflects the amount of time in minutes participants were effectively sleeping while in bed, without periods of wakefulness, on average over the past month. This will be measured by item 4 of the PSQI questionnaires: "How many hours of actual sleep do you get at night?".Measure: Change in Subjective Total Sleep Time (TST) Time: Up to one month
Description: Measured within the Pittsburgh Sleep Quality Index. This is the perceived time, in minutes, that takes participants to fall asleep from the moment they go to bed. This corresponds to item 2 of the PSQI: "How long (in minutes) has it taken you to fall asleep each night?"Measure: Change in Subjective Sleep Onset Latency (SOL) Time: Up to one month
Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. In addition to Sleep Onset Latency (Secondary outcome 1), a second subjective measure of sleep quality is extracted from the PSQI: time of perceived wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed (TST) minus total sleep time (TST) and minus sleep onset latency (SOL), in minutes. High WASO scores reflect low sleep continuity and poor sleep quality.Measure: Change in Subjective Wake After Sleep Onset (WASO) Time: Up to one month
The aim of this study is to investigate the levels of insomnia 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). The study also aims to investigate how predictors measured after and before the COVID-19 pandemic are associated with sleep problems at T2.
Description: Bergen Insomnia scale is developed as a short measure of insomnia consisting of six items measured on a 8-point Likert-scale (Pallesen et al., 2008)Measure: Bergen insomnia scale (BIS) Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.
Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.Measure: Depression, Anxiety and Stress Scales 21 Score Time: 5 months
Description: The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.Measure: Insomnia severity index score Time: 5 months
Data processed on September 26, 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