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Remote Cognitive Behavioral Therapy for InsomniaWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Name (Synonyms) Correlation

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D020920 Dyssomnias NIH 0.45
D020447 Parasomnias NIH 0.45

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms

The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lessen negative mental health outcomes in the wake of the COVID-19 crisis in adults.

NCT04409743 Sleep Disturbance Insomnia Behavioral: Remote Cognitive Behavioral Therapy for Insomnia
MeSH:Dyssomnias Parasomnias

Primary Outcomes

Description: Whether the participant has an insomnia clinical diagnosis will be measured by the DUKE. The DUKE is a structured interview which screens for sleep disorders in accordance with criteria of both the DSM-IV and the international classification of sleep disorders (ICSD-2). The DUKE is composed of 4 modules that assess sleep disorder symptoms associated with complaints of insomnia, sleep disorders associated with complaints of hypersomnia, circadian rhythm sleep disorders, and sleep disorders associated with parasomnias.

Measure: Change in Insomnia Clinical Diagnosis

Time: Assessed at week 0 and week 15

Description: This measure is of the Beck Depression Inventory-II total score after excluding one sleep item. The average item score for the remaining 20 items will be multiplied by 21 (the original number of items), to create a modified depression scale that maintains the original range (ranges: 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe). The BDI-II is a 21-item self-report scale with high validity and reliability that assesses the severity of depression symptoms. The depression items consist of: sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. Items are scored from 0 to 3, and higher scores indicate greater levels of severity.

Measure: Change in Beck Depression Inventory-II (BDI) Scale Score

Time: Assessed at week 0 and week 15

Description: Clinical anxiety symptoms will be measured by the BAI. The BAI is a 21-item self-report scale that assesses the severity of anxiety symptoms. Items are scored from 0 to 3 (0 = not at all, 3 = severe). Higher scores indicate greater levels of severity, and the ranges for anxiety levels are: 0-9 normal to minimal, 10-18 mild to moderate, 19-29 moderate to severe, and 30-63 severe. The BAI consists of two factors: somatic and cognitive.

Measure: Change in Beck Anxiety Inventory (BAI) Scale Score

Time: Assessed at week 0 and week 15

Description: The SF-36 is a 36-item self-administered survey to assess comprehensive quality-of-life measures. It consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, and mental health. This survey is widely used and has been proven to be a reliable indicator of quality-of-life measures. The global score range is 0-100, with higher scores indicating better health conditions.

Measure: Change in Quality of Life (SF-36) Scale Score

Time: Assessed at week 0 and week 15

Description: Suicidality ideation and behaviors will be measured by the S-STS. The S-STS is a 16-item 0 to 4 scale (0 = no problem, 4 = very severe problem) that assesses the risk of suicidality. For this outcome measure, 15 items (excluding #13) are summed for an overall score range of 0 to 45 (higher scores indicate more severe problems).

Measure: Change in Sheehan Suicidality Tracking Scale (S-STS) Score

Time: Assessed at week 0 and week 15

Description: The FIRST is 9 item self-report that assess sleep reactivity with individual items scored on a 1 - 4 scale (1 = Not Likely, 4 = Very Likely). This self-report tools measures the risk of participants experiencing situational insomnia due to common stressful conditions. The FIRST has good reliability and validity and has demonstrated high internal consistency across multiple demographics in both males and females, in young and middle-aged adults, and in clinical and population-based samples. Individual items are summed for a total score range of 9 to 36, with higher scores corresponding to more difficulty sleeping

Measure: Change in Ford Insomnia Response to Stress Test (FIRST) Scale Score

Time: Assessed at week 0 and week 15

Description: Loneliness risk factors will be assessed with the UCLA Loneliness Scale that measures a participant's subjective feelings of loneliness and social isolation. The UCLA Loneliness Scale has 20 items, each on a 1 to 4 scale (1 = Never, 4 = Often), summed for an overall range of 20 to 80 with higher scores indicating greater degrees of loneliness.

Measure: Change in UCLA Loneliness Scale Score

Time: Assessed at week 0 and week 15

Description: The Social Network Index is a 12-item questionnaire that assess participation in different types of social relationships. The 12 types of relationships (e.g. friend, children, spouse, religious group member) are scored by the number network members they communicate with at least every 2 weeks.

Measure: Change in Social Network Index (SNI) Scale Score

Time: Assessed at week 0 and week 15

Description: The Perceived Stress Scale is a widely used self-reported questionnaire that assesses how stressful participants believe their live is. Items are generalized and measure the degree participants judge their lives to be uncontrollable and unpredictable over the course of the previous month.

Measure: Change in Perceived Stress Scale Score

Time: Assessed at week 0 and week 15

Description: Self-report questions regarding screen time will be included in the Coronavirus Health Impact Survey. Questions measure the amount of time spent per day, over the course of the two most recent weeks, using an electronic device.

Measure: Change in Screen Time- Self Report

Time: Assessed at week 0 and week 15

Description: The International Physical Activity Questionnaire assess an individual's physical activity across 5 life domains over the last 7 days. The activity domains consist of physical activity related to work, transportation, housework and caring for family, and recreation and sports as well as the amount of time spent sitting. The IPAQ has high reliability and validity and has been widely used to measure comparable estimates of physical activity in large populations.

Measure: Change in International Physical Activity Questionnaire (IPAQ) Scale Score

Time: Assessed at week 0 and week 15

Secondary Outcomes

Description: Sleep Onset Latency (SOL) is the time (minutes) from "lights out" to actually falling asleep (sleep onset) based on sleep logs.

Measure: Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Number of Arousals is determined by number of times of awakening as seen on the actigraph data.

Measure: Change in Number of Arousals as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).

Measure: Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.

Measure: Change in Total Sleep Time (TST) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.

Measure: Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity

Time: Assessed at week 0 and week 15

Description: Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.

Measure: Change in Insomnia Severity Index (ISI) Scale Score

Time: Assessed at week 0 and week 15

Description: The PHQ-9 is a self-administered 9-item 0 to 3 scale (0 = not at all, 3 = nearly every day) questionnaire that assess each of the 9 DSM-IV depression criteria. The total score ranges from 1 - 27 which measures the severity of the reported depression with consideration for both Major Depressive Disorder and other depressive disorders based on the number of items that were rated a 2 to 3.

Measure: Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms

Time: Assessed at week 0 and week 15

Description: The GAD-7 is a widely used diagnostic self- report scale that screens, diagnoses, and assess severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.

Measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score

Time: Assessed at week 0 and week 15


No related HPO nodes (Using clinical trials)