Brief Versus Standard Cognitive Behavioral Therapy for Insomnia in Veterans

NCT05724498 | Terminated DMC

• 2 other identifiers: D3840-R1I01RX003840-01A2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Insomnia

Keywords

Insomnia; Cognitive-Behavioral Therapy for Insomnia; Functional Health; Mental Health; Veterans

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index (ISI) scores from pretreatment to follow-up

  Measure of insomnia severity (0-24; higher score equals worse insomnia)

  Week 0 (baseline) and Week 20 (follow-up)

Secondary Outcomes (7)

• Change in Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10)

  Week 0 (baseline) and Week 20 (follow-up)

• Change in Pittsburgh Sleep Quality Index (PSQI) scores from pretreatment to follow-up

  Week 0 (baseline) and Week 20 (follow-up)

• Change in WHO Disability Assessment Schedule (WHODAS 2.0)

  Week 0 (baseline) and Week 20 (follow-up)

• Change in Brief Inventory of Psychosocial Functioning (B-IPF)

  Week 0 (baseline) and Week 20 (follow-up)

• Change in PTSD Checklist for DSM 5 (PCL-5)

  Week 0 (baseline) and Week 20 (follow-up)

Study Arms (2)

Cognitive-Behavioral Therapy for Insomnia (CBT-I)

ACTIVE COMPARATOR

Compare two behavioral interventions for insomnia

Behavioral: Brief CBT-I; Behavioral: Standard CBT-I

Standard Cognitive-Behavioral Therapy for Insomnia (CBT-I)

ACTIVE COMPARATOR

Standard VA 6 session version of CBT-I

Behavioral: Brief CBT-I; Behavioral: Standard CBT-I

Interventions

Standard CBT-I BEHAVIORAL

Standard VA 6 session CBT-I

Cognitive-Behavioral Therapy for Insomnia (CBT-I); Standard Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Brief CBT-I BEHAVIORAL

4 session CBT-I

Cognitive-Behavioral Therapy for Insomnia (CBT-I); Standard Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• History of a acute or unstable neurological disorder(s), dementia, or premorbid IQ \<70
• Schizophrenia, psychotic disorder, and/or bipolar disorder
• Suicidality more than "medium risk" as determined by the VA Comprehensive Suicide Risk Assessment
• Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea, periodic limb movements, narcolepsy, and/or circadian-based sleep disruptions)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Finger Lakes Healthcare System: collaborator

Study Sites (2)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Peter Colvonen, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Veterans randomized to either brief (4 session) or full (6 session) Cognitive-Behavioral Therapy for Insomnia.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)