Comparing brief and standard cognitive behavioral therapy for insomnia in veterans
A Randomized Clinical Trial Comparing Brief and Standard Cognitive-Behavioral Therapies for Insomnia in Veterans
This study is testing whether a shorter 4-session therapy for insomnia can help veterans sleep better just as well as the standard 6-session therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT05724498 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of a 4-session brief Cognitive Behavioral Therapy for Insomnia (CBT-I) against the standard 6-session CBT-I in veterans suffering from insomnia. Insomnia is prevalent among veterans, often leading to significant functional impairment and mental health issues. The study will evaluate whether the shorter intervention can provide similar benefits in improving sleep and overall functioning. Participants will be veterans diagnosed with insomnia and a comorbid mental health disorder, who have not received CBT-I treatment in the past two years.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans diagnosed with insomnia and a comorbid mental health disorder who have not received CBT-I treatment in the last two years.
Not a fit: Patients with acute or unstable neurological disorders, schizophrenia, or other severe mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and time-efficient treatment option for veterans suffering from insomnia.
How similar studies have performed: While studies have shown the efficacy of standard CBT-I, this approach of comparing brief CBT-I to standard treatment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. Meets current DSM 5 criteria for a comorbid mental health disorder 3. No formal therapist guided treatment with brief or standard Cognitive-Behavioral Therapy for Insomnia within the past 2 years 4. on stable medication regimen for at least 4 weeks prior to enrollment in study. Exclusion Criteria: 1. History of a acute or unstable neurological disorder(s), dementia, or premorbid IQ \<70 2. Schizophrenia, psychotic disorder, and/or bipolar disorder 3. Suicidality more than "medium risk" as determined by the VA Comprehensive Suicide Risk Assessment 4. Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea, periodic limb movements, narcolepsy, and/or circadian-based sleep disruptions) 5. alcohol and/or substance use disorder for 90 days prior to intake, but past history of alcohol and/or substance use is not exclusionary.
Where this trial is running
San Diego, California and 1 other locations
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
- VA Finger Lakes Healthcare System, Canandaigua, NY — Canandaigua, New York, United States (Recruiting)
Study contacts
- Principal investigator: Henry J. Orff, PhD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Henry J Orff, PhD
- Email: Henry.Orff@va.gov
- Phone: (858) 642-6492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.