Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID05780177

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Led by VA Office of Research and Development ยท Updated on 2026-04-21

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for insomnia in Veterans diagnosed with posttraumatic stress disorder (PTSD). This study compares a brief behavioral treatment for insomnia (BBTI) with progressive muscle relaxation training (PMRT) to examine improvements in psychosocial functioning and insomnia severity. The study also investigates whether treatment benefits last over time and if suicidal thoughts decrease after insomnia treatment. Participants will be randomly assigned to one of two groups. One group receives four sessions of BBTI, involving video and telephone meetings lasting between 30 to 60 minutes, without relaxation techniques. The other group receives four sessions of PMRT, also delivered via video and telephone, using relaxation training matched in duration to BBTI. Both interventions include two video sessions and two phone sessions. The BBTI group will have a 6-month follow-up to assess the durability of treatment effects. Participants will complete mental health interviews and self-report measures on psychosocial functioning, insomnia severity, and mental health symptoms at baseline, mid-treatment, post-treatment, and 6-month follow-up for the BBTI group. Sleep patterns will be tracked through daily sleep diaries starting one week before treatment through post-treatment, and at 6-month follow-up for BBTI participants. Researchers will assess work and social adjustment as the primary outcome and insomnia severity as a secondary outcome, along with monitoring suicidal ideation using established scales throughout the study.

CONDITIONS

Brief Title

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Stable on insomnia, PTSD, or other psychotropic medications for at least one month with no changes during treatment
  • Stable on any psychotherapy for at least one month with no planned discontinuation during the trial
  • Completed or waited one month after evidence-based insomnia or PTSD therapy before enrolling
  • Individuals with mild to severe traumatic brain injury (TBI) are eligible
  • Individuals with chronic pain are eligible
  • Individuals with treated or untreated sleep apnea or at high risk for sleep apnea are eligible
Not Eligible

You will not qualify if you...

  • 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 recent suicidal behaviors, hospitalization, or prominent suicidal ideation with intent or plan
  • Veterans who are pregnant
  • Veterans who work night or rotating shifts
  • Veterans with unstable housing
  • Veterans with untreated medical conditions affecting sleep, such as restless legs syndrome
  • Veterans with uncontrolled seizure disorder
  • Veterans unable to participate in video treatment sessions or complete online surveys

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for mental health diagnostic interviews and baseline assessments

Outpatient Treatment

Duration - Approximately 4 weeks

Participants receive four behavioral treatment sessions for insomnia or progressive muscle relaxation training through video and phone encounters.

4 sessions via video and phone (one 60-minute, one 45-minute video, and two 30-minute phone sessions)

Follow-up

Duration - Up to 6 months after treatment

Participants complete assessments of psychosocial functioning, insomnia severity, and mental health symptoms at post-treatment and at 6-month follow-up (for the treatment group only).

3 assessment points: post-treatment, mid-treatment, and 6-month follow-up (6-month follow-up only for treatment group)

Trial Site Locations

Total: 1 location

1

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States, 94121-1563

Actively Recruiting

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Research Team

S

Shira Maguen, PhD

J

Joy Huggins, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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