ClinConnect ClinConnect Logo
Search / Trial NCT05780177

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Mar 9, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ptsd Insomnia

ClinConnect Summary

This clinical trial is looking at ways to help veterans who have both posttraumatic stress disorder (PTSD) and insomnia. Researchers want to see if a short behavioral treatment for insomnia is more effective than a relaxation technique called progressive muscle relaxation training. They will track how well participants sleep and how their overall well-being improves, as well as whether these benefits last over time and if feelings of wanting to harm oneself decrease after treatment.

To join the study, participants need to be veterans aged 18 to 75 who have been diagnosed with insomnia and current PTSD. They should be stable on any medications they are taking and have participated in any ongoing therapy for at least a month. The study is open to veterans who might have other conditions, like traumatic brain injury or chronic pain, but those with certain serious mental health issues, severe substance use problems, or unstable living situations are not eligible. Participants can expect to engage in treatments that aim to improve their sleep and potentially enhance their quality of life.

Gender

ALL

Eligibility 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.

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Shira Maguen, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials