NCT05780177

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, controlled trial of a video- and telephone-based, brief insomnia treatment in Veterans who meet criteria for Insomnia Disorder and Posttraumatic Stress Disorder (PTSD) to accomplish the goal of improving psychosocial functioning. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include assessing durability of treatment gains and evaluating whether suicidal ideation decreases after insomnia treatment. Eighty Veterans with Insomnia Disorder and PTSD will be randomly assigned to either Brief Behavioral Treatment for Insomnia (BBTI; one 60-minute and one 45-minute video encounter, and two 30-minute phone-based encounters) or a Progressive Muscle Relaxation Training control group (manualized relaxation training delivered by two video and two phone sessions, matched to the BBTI condition for therapist time). Prior to randomization, participants will complete clinician-administered, mental health diagnostic interviews at baseline (and post-treatment). Self-report measures of psychosocial functioning, insomnia severity, and other mental health symptoms will be completed at baseline (pretreatment), mid-treatment, post-treatment, and at 6-month follow-up (BBTI group only). Sleep parameters will be completed with a self-report sleep diary. One week of sleep parameters data will be collected at baseline and continuously to the post-treatment appointment (and at 6-month follow-up for the BBTI group only). The investigators also will explore whether BBTI decreases suicidal ideation, which often occurs in Veterans with PTSD and insomnia, using the Depressive Symptom Index: Suicidality Subscale and the Columbia Suicide Severity Rating Scale, the latter which is used clinically in VA to assess suicide risk.

Conditions

• Posttraumatic Stress Disorder
• Insomnia Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2023-03-22
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States