Recruiting

BBTI & PMRT

Sponsor:

VA Office of Research and Development

Code:

NCT05780177

Conditions

Posttraumatic Stress Disorder

Insomnia Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Brief Behavioral Treatment for Insomnia (BBTI)

Progressive Muscle Relaxation Training (PMRT)

Study Details

Brief summary:

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.

Conditions

Posttraumatic Stress Disorder

Insomnia Disorder

Study ID

NCT05780177

Start date

May 1, 2023

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BBTI

Participants in this arm will receive 4 sessions (30-60 minutes) of a brief behavioral treatment for insomnia (BBTI). Relaxation techniques are not a component of BBTI.

active comparator: PMRT

Participants in this arm will receive 4 sessions (30-60 minutes) of progressive muscle relaxation training (PMRT).

Interventions

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.

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 measure

  • Work and Social Adjustment Scale (WSAS) Change [ Time Frame: Change from baseline (Week 1) to posttreatment (Week 5) ]
  • Work and Social Adjustment Scale (WSAS) Change [ Time Frame: Change from baseline (Week 1) to 6-month follow-up--for treatment arm only ]

Central Contacts and Locations

Central contacts

Shira Maguen, PhD

(415) 221-4810shira.maguen@va.gov

Joy Huggins, MA

(415) 221-4810Joy.Huggins@va.gov

Locations

San Francisco VA Medical Center, San Francisco, CA

Recruiting

San Francisco, California, United States, 94121-1563

Contacts

Shira Maguen, PhD

(415) 221-4810shira.maguen@va.gov

Principal Investigator:

Shira Maguen, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • PTSD
  • Insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-21.