Clinical trial for Posttraumatic Stress Disorder
Official title Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
ClinicalTrials.gov ID: NCT05780177
What this study is testing
- What it's testing
- The study compares a brief behavioral treatment for insomnia (BBTI) with progressive muscle relaxation training (PMRT) to see which improves sleep, daily functioning, and reduces suicidal thoughts.
- Who it's for
- Veterans who have both post‑traumatic stress disorder and insomnia.
- What's involved
- Participants will be assigned to either the brief behavioral sleep program or the relaxation training, with regular sessions and follow‑up assessments of sleep and mood.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- If currently receiving any type of psychotherapy, must have received this treatment for at least one month and do not plan to discontinue treatment...
You likely can't join if
- 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.
- Veterans who are pregnant
- Veterans who work night or rotating shifts
- Veterans with unstable housing
See the full eligibility 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.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.