Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
VA Office of Research and Development · NCT05780177
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 200
- US sites recruiting
- 1
- Study start
- May 1, 2023
- Record last updated
- April 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.
Being studied: Brief Behavioral Treatment for Insomnia (BBTI); Progressive Muscle Relaxation Training (PMRT)
Conditions: Posttraumatic Stress Disorder; Insomnia Disorder
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
San Francisco VA Medical Center, San Francisco, CA
San Francisco, CA 94121-1563
Site contact: Shira Maguen, PhD · (415) 221-4810 · shira.maguen@va.gov
Study contacts (from the official record)
- Shira Maguen, PhD · (415) 221-4810 · shira.maguen@va.gov
- Joy Huggins, MA · (415) 221-4810 · Joy.Huggins@va.gov
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