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

NCT04409743 | Completed

• 1 other identifier: IRB-55940
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Insomnia

Keywords

Sleep; CBT-I; Cognitive Behavioral Therapy; COVID-19

Outcome Measures

Primary Outcomes (11)

• Change in Insomnia Clinical Diagnosis Over Time

  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.

  Assessed at week 0, month 3, month 7, and month 13

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

  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.

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

• Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Over Time

  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.

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

• Change in Insomnia Severity Index (ISI) Scale Score Over Time

  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.

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

• Change in Quality of Life (SF-36) Scale Score Over Time

  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.

  Assessed at week 0, month 3, month 7, and month 13

• Change in Sheehan Suicidality Tracking Scale (S-STS) Score Over Time

  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).

  Assessed at week 0, month 3, month 7, and month 13

• Change in UCLA Loneliness Scale Score Over Time

  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.

  Assessed at week 0, month 3, month 7, and month 13

• Change in Social Network Index (SNI) Scale Score Over Time

  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.

  Assessed at week 0, month 7, and month 13

• Change in Perceived Stress Scale Score Over Time

  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.

  Assessed at week 0, month 3, month 7, and month 13

• Change in Screen Time- Self Report Over Time

  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.

  Assessed at week 0, week 7, month 3, month 7, and month 13

• Change in International Physical Activity Questionnaire (IPAQ) Scale Score Over Time

  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.

  Assessed at week 0, month 3, month 7, and month 13

Secondary Outcomes (7)

• Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity Over Time

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

• Change in Number of Awakenings as a Measure of Sleep Continuity Over Time

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

• Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity Over Time

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

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

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

• Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity Over Time

  Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13

Study Arms (2)

Immediate Treatment

ACTIVE COMPARATOR

The sleep treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants randomized to this arm will begin treatment immediately after randomization.

Behavioral: Remote Cognitive Behavioral Therapy for Insomnia

Waitlist

OTHER

The subjects assigned to the Waitlist condition will receive the same CBT-I treatment 7 months after randomization.

Behavioral: Remote Cognitive Behavioral Therapy for Insomnia

Interventions

Remote Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Also known as: CBT-I

Immediate Treatment; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• O'Hora KP, Osorno RA, Sadeghi-Bahmani D, Lopez M, Morehouse A, Kim JP, Manber R, Goldstein-Piekarski AN. Viability of an Early Sleep Intervention to Mitigate Poor Sleep and Improve Well-being in the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 14;11(3):e34409. doi: 10.2196/34409.

  PMID: 34995204 RESULT

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders; COVID-19

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrea Goldstein-Piekarski, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 1, 2020
• Study Start: June 7, 2020
• Primary Completion: October 14, 2021
• Study Completion: April 19, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)