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Brief Behavioral Treatment for Insomnia in Veterans With PTSD

This study is for military veterans aged 18-75 who have both insomnia and posttraumatic stress disorder (PTSD). It compares two treatments for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) and Progressive Muscle Relaxation Training (PMRT). Researchers want to see if these treatments improve daily functioning and insomnia symptoms, and if any benefits last over time. They will also check if suicidal thoughts decrease after treatment. You must be stable on any current medications for at least one month. The study's current status is unclear, and it plans to enroll 200 participants.

Study design
This is a randomized, controlled study. It will compare two different behavioral treatments for insomnia in 200 participants.
What's involved
You would have four sessions (30-60 minutes each) of either BBTI or PMRT, delivered by video and phone. You will also complete interviews and self-report questionnaires at different times, including a sleep diary.
Compensation
Not stated in the trial record.
Follow-up
Participants in the BBTI group will have a follow-up at 6 months after treatment.

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NCT05780177

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Recruiting
NAAges 18–75InterventionalTreatment
VA Office of Research and Development
~200 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Brief Behavioral Treatment for Insomnia (BBTI)Progressive Muscle Relaxation Training (PMRT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Work and Social Adjustment Scale (WSAS) Change
Measured over Change from baseline (Week 1) to posttreatment (Week 5)
+1 more outcome measured

Conditions

Posttraumatic Stress Disorder
Insomnia Disorder

Explore related trials

InsomniaPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Shira Maguen, PhD · PRINCIPAL_INVESTIGATOR · San Francisco VA Medical Center, San Francisco, CA

Who to contact

Shira Maguen, PhD
[email protected]
(415) 221-4810 · ext. 2511
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Work and Social Adjustment Scale (WSAS) ChangeChange from baseline (Week 1) to posttreatment (Week 5)

    Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.

  • Work and Social Adjustment Scale (WSAS) ChangeChange from baseline (Week 1) to 6-month follow-up--for treatment arm only

    Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.