Behavioral treatment for insomnia in veterans with PTSD
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
This study is testing a short behavioral treatment for insomnia to see if it helps veterans with PTSD sleep better compared to a relaxation training method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05780177 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a brief behavioral treatment for insomnia (BBTI) compared to progressive muscle relaxation training (PMRT) in veterans suffering from posttraumatic stress disorder (PTSD) and insomnia disorder. It is a randomized, controlled trial involving video and telephone-based sessions aimed at improving psychosocial functioning and reducing insomnia severity. Participants will be assessed for treatment outcomes through clinician-administered interviews and self-report measures at various stages, including a 6-month follow-up. The study also aims to evaluate the durability of treatment gains and the impact on suicidal ideation.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 18-75 who meet the criteria for both insomnia disorder and current PTSD.
Not a fit: Patients currently engaged in evidence-based treatments for insomnia or PTSD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall mental health for veterans with PTSD.
How similar studies have performed: Other studies have shown promising results with behavioral treatments for insomnia, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals between the ages of 18-75 years who served in the military * Veterans who meet DSM-5 Criteria for Insomnia Disorder. * Veterans who meet DSM-5 Criteria for current PTSD * If currently taking insomnia, PTSD or other psychotropic medications, must be stable on these medications for at least one month and not make any changes to medications during the active treatment phase of the study. * If currently receiving any type of psychotherapy, must have received this treatment for at least one month and do not plan to discontinue treatment during the BBTI trial. Individuals planning to start a new type of psychotherapy will be required to wait one month prior to study enrollment. Individuals currently engaged or planning to engage in evidence-based treatments that are recognized by the VA as directly targeting insomnia or PTSD (i.e., Cognitive Behavioral Therapy for Insomnia, Cognitive Processing Therapy, or Prolonged Exposure Therapy) must complete treatment and wait one month prior to screening for the trial. * The investigators will not exclude individuals with TBI, given that prior studies have found that individuals with mild to severe TBI can benefit from behavioral interventions for insomnia. * The investigators will not exclude individuals with chronic pain, given that prior studies have found that these individuals can benefit from behavioral interventions for insomnia. * The investigators will not exclude individuals with treated sleep apnea or untreated sleep apnea or individuals that are high-risk for sleep apnea. Prior research has found that these individuals can benefit from behavioral interventions for insomnia. Recent research has also established that individuals with untreated mild, moderate or severe sleep apnea or those high-risk for sleep apnea are more likely to receive assessment and treatment for this condition after completing behavioral treatment for insomnia. Exclusion Criteria: * Veterans with a lifetime history of psychotic disorder or manic episodes. * Veterans with moderate to severe alcohol or substance use disorder. * Veterans with recent homicidal behaviors. Veterans with suicidal ideation will not be excluded. However, Veterans with recent suicidal behaviors or hospitalization or those who report prominent suicidal ideation with intent or a plan will be excluded. * Veterans who are pregnant * Veterans who work night or rotating shifts * Veterans with unstable housing * Veterans with untreated medical conditions that are known to affect sleep (e.g., restless legs syndrome) * Veterans with uncontrolled seizure disorder. Sleep restriction is contraindicated for people with uncontrolled seizures due to the possibility of triggering a seizure. * Veterans who are unable to participate in video treatment sessions or complete online surveys.
Where this trial is running
San Francisco, California
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Shira Maguen, PhD — San Francisco VA Medical Center, San Francisco, CA
- Study coordinator: Shira Maguen, PhD
- Email: shira.maguen@va.gov
- Phone: (415) 221-4810
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.