NCT05780177 · VA Office of Research and Development
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
(BBTI & PTSD)
What this 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Brief Behavioral Treatment for Insomnia (BBTI)
Participants in this arm will receive 4 sessions (30-60 minutes) of a brief behavioral treatment for insomnia called BBTI. Relaxation techniques are not a component of BBTI.
BEHAVIORAL
Progressive Muscle Relaxation Training (PMRT)
Participants in this arm will receive 4 sessions (30-60 minutes) of progressive muscle relaxation training called PMRT.
Primary outcome measures
Work and Social Adjustment Scale (WSAS) Change
Time frame: Change 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) Change
Time frame: Change 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations