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

NCT ID: NCT04409743

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-07
• Study Completion Date: 2022-04-19

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.

Conditions

Sleep Disturbance; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Immediate Treatment

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

Group Type: ACTIVE_COMPARATOR

Remote Cognitive Behavioral Therapy for Insomnia

Intervention Type: 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.

Waitlist

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

Group Type: OTHER

Remote Cognitive Behavioral Therapy for Insomnia

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-I

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Goldstein-Piekarski, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34995204 (View on PubMed)

Other Identifiers

IRB-55940

Identifier Type: -

Identifier Source: org_study_id