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Brief Telehealth CBT-I Intervention in the Context of the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409743
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE May 28, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE June 7, 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
  • Change in Insomnia Clinical Diagnosis Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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.
  • Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    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.
  • Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    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.
  • Change in Insomnia Severity Index (ISI) Scale Score Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    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.
  • Change in Quality of Life (SF-36) Scale Score Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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.
  • Change in Sheehan Suicidality Tracking Scale (S-STS) Score Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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).
  • Change in UCLA Loneliness Scale Score Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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.
  • Change in Social Network Index (SNI) Scale Score Over Time [ Time Frame: Assessed at week 0, month 7, and month 13 ]
    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.
  • Change in Perceived Stress Scale Score Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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.
  • Change in Screen Time- Self Report Over Time [ Time Frame: Assessed at week 0, week 7, month 3, month 7, and month 13 ]
    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.
  • Change in International Physical Activity Questionnaire (IPAQ) Scale Score Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Change in Insomnia Clinical Diagnosis [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Beck Depression Inventory-II (BDI) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Beck Anxiety Inventory (BAI) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Quality of Life (SF-36) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Sheehan Suicidality Tracking Scale (S-STS) Score [ Time Frame: Assessed at week 0 and week 15 ]
    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).
  • Change in Ford Insomnia Response to Stress Test (FIRST) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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
  • Change in UCLA Loneliness Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Social Network Index (SNI) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Perceived Stress Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Screen Time- Self Report [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in International Physical Activity Questionnaire (IPAQ) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
  • Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    Sleep Onset Latency (SOL) is the time (minutes) from "lights out" to actually falling asleep (sleep onset) based on sleep logs.
  • Change in Number of Awakenings as a Measure of Sleep Continuity Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    Number of Awakenings is determined by number of times of awakening as reported on sleep logs.
  • Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).
  • Change in Total Sleep Time (TST) as a Measure of Sleep Continuity Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.
  • Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity Over Time [ Time Frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13 ]
    Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.
  • Change in Beck Depression Inventory-II (BDI) Scale Score Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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.
  • Change in Beck Anxiety Inventory (BAI) Scale Score Over Time [ Time Frame: Assessed at week 0, month 3, month 7, and month 13 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity [ Time Frame: Assessed at week 0 and week 15 ]
    Sleep Onset Latency (SOL) is the time (minutes) from "lights out" to actually falling asleep (sleep onset) based on sleep logs.
  • Change in Number of Arousals as a Measure of Sleep Continuity [ Time Frame: Assessed at week 0 and week 15 ]
    Number of Arousals is determined by number of times of awakening as seen on the actigraph data.
  • Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity [ Time Frame: Assessed at week 0 and week 15 ]
    Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).
  • Change in Total Sleep Time (TST) as a Measure of Sleep Continuity [ Time Frame: Assessed at week 0 and week 15 ]
    Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.
  • Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity [ Time Frame: Assessed at week 0 and week 15 ]
    Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.
  • Change in Insomnia Severity Index (ISI) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms [ Time Frame: Assessed at week 0 and week 15 ]
    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.
  • Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score [ Time Frame: Assessed at week 0 and week 15 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Telehealth CBT-I Intervention in the Context of the COVID-19 Pandemic
Official Title  ICMJE Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms
Brief Summary 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.
Detailed Description

The COVID-19 Pandemic and the resulting mass home confinement enacted to mitigate disease spread has created an environment of stress and drastic disruption to daily life. Increases in stress, social isolation, loss of daily routine, decreased physical activity, and excess screen time that are likely to arise as a function of the pandemic and mitigation efforts are risk factors for developing insomnia. Left unchecked, this acute insomnia can become chronic, resulting in increased risk of negative mental health outcomes such as depression, anxiety, and suicidality. The current proposal aims to test whether a telehealth intervention for insomnia can be used to not only prevent the progression of acute to chronic insomnia, but also prevent the worsening of neuropsychiatric symptoms, suicidality, and quality of life in those most vulnerable to negative mental health outcomes.

These aims will be achieved through a randomized 2-arm controlled trial design. 50 eligible adults experiencing sleep disturbances and who also have a history of depression and are in the at-risk group for COVID-19 will be randomized to receive either a sleep intervention (Cognitive Behavioral Therapy for Insomnia, CBT-I; n=25) or a 7-month waitlist (n=25). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, Quality of Life, suicidality, and sleep disruption will be assessed at baseline (Week 0) and at the end of the sleep intervention (or Week 7) through online surveys and clinical interviews. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout treatment/waitlist to assess week-to-week changes following an increasing number of CBT-I sessions. Neuropsychiatric symptoms, quality of life, suicidality, and sleep will be assessed again at 3-months, 7-months, and 13-months after baseline.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Sleep Disturbance
  • Insomnia
Intervention  ICMJE Behavioral: Remote Cognitive Behavioral Therapy for Insomnia
Participants will meet with a psychologist through telehealth once a week for four weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.
Other Name: CBT-I
Study Arms  ICMJE
  • Active Comparator: Immediate Treatment
    The sleep treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants randomized to this arm will begin treatment immediately after randomization.
    Intervention: Behavioral: Remote Cognitive Behavioral Therapy for Insomnia
  • Waitlist
    The subjects assigned to the Waitlist condition will receive the same CBT-I treatment 7 months after randomization.
    Intervention: Behavioral: Remote Cognitive Behavioral Therapy for Insomnia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 7, 2021)
49
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
100
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or older
  • Access to the internet
  • Subjective complaint of sleep disturbance (ISI ≥10) that began after March 1, 2020 or the COVID-19 Pandemic (self-reported during DUKE Interview)
  • Lives in the United States

Exclusion Criteria:

  • Presence of suicidal ideation representing high risk as measured by the Sheehan-Suicide Tracking Scale (S-STS).
  • Use of medication specifically prescribed for sleep disturbance and unwilling or unable to discontinue more than one week prior to baseline data collection.
  • Current or lifetime history of bipolar disorder or psychosis
  • Current substance abuse or dependence
  • Not able to verbalize understanding of involvement in research and provide written, informed consent
  • Not fluent or literate in English
  • Unstable pharmacotherapy for other mental health disorders
  • Severe impediment to vision, hearing, and/or hand movement, likely to interfere with the ability to complete assessments, or are unable and/or unlikely to follow study protocols
  • Working rotating shift that overlaps with 2400h
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04409743
Other Study ID Numbers  ICMJE IRB-55940
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Goldstein-Piekarski, PhD Stanford University
PRS Account Stanford University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP