A Randomized Clinical Trial Comparing Brief and Standard Cognitive-Behavioral Therapies for Insomnia in Veterans

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Insomnia is a common condition in Veterans, with prevalence rates as high as 53% among treatment-seeking Veterans. Chronic untreated insomnia is associated with increased risk for functional impairment, psychiatric illness, suicidal ideation, unhealthy lifestyles, and decreased quality of life. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is recognized as the first-line treatment for insomnia. Despite its proven efficacy, CBT-I is not always readily provided and/or accessible to Veterans. To address these limitations, behavioral sleep medicine specialists have endeavored to streamline CBT-I through development of time-shortened variations of CBT-I. Although these modifications show promise for advancing care and access, studies comparing brief treatments to standard CBT-I have yet to be performed. This investigation will therefore compare a 4-session brief CBT-I to VA standard 6-session CBT-I to evaluate whether a brief intervention can provide comparable benefits to sleep, functional, and psychiatric outcomes in Veterans with insomnia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A diagnosis of insomnia as classified by the (a) Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) which includes daytime impairment in functioning for \> 3 months and occurring at least 3 nights per week and (b) subjective sleep disturbance defined by an Insomnia Severity Index (ISI) score \>7 at intake

• Meets current DSM 5 criteria for a comorbid mental health disorder

• No formal therapist guided treatment with brief or standard Cognitive-Behavioral Therapy for Insomnia within the past 2 years

• on stable medication regimen for at least 4 weeks prior to enrollment in study.

Locations
United States
California
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
New York
VA Finger Lakes Healthcare System, Canandaigua, NY
RECRUITING
Canandaigua
Contact Information
Primary
Henry J Orff, PhD
Henry.Orff@va.gov
(858) 642-6492
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 250
Treatments
Active_comparator: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Compare two behavioral interventions for insomnia
Active_comparator: Standard Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Standard VA 6 session version of CBT-I
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: VA Finger Lakes Healthcare System

This content was sourced from clinicaltrials.gov