Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

NCT05780177 | Recruiting

• 1 other identifier: D4243-R
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

PTSD; Insomnia

Outcome Measures

Primary Outcomes (2)

• Work and Social Adjustment Scale (WSAS) Change

  Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.

  Change from baseline (Week 1) to posttreatment (Week 5)

• Work and Social Adjustment Scale (WSAS) Change

  Assesses functioning in work, home management, social leisure activities, private leisure activities and relationships with others. It is a five-item measure with each item rated on a 0 to 8 scale, with higher scores reflecting greater impairment.

  Change from baseline (Week 1) to 6-month follow-up--for treatment arm only

Secondary Outcomes (2)

• Insomnia Severity Index (ISI)

  Change from baseline (Week 1) to posttreatment (Week 5)

• Insomnia Severity Index (ISI)

  Change from baseline (Week 1) to 6-month follow-up--for treatment arm only

Other Outcomes (2)

• Depressive Symptom Index: Suicidality Subscale (DSI-SS)

  Change from baseline (Week 1) to 6-month follow-up--for treatment arm only

• Depressive Symptom Index: Suicidality Subscale (DSI-SS)

  Change from baseline (Week 1) to posttreatment (Week 5)

Study Arms (2)

BBTI

EXPERIMENTAL

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.

Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

PMRT

ACTIVE COMPARATOR

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

Behavioral: Progressive Muscle Relaxation Training (PMRT)

Interventions

Progressive Muscle Relaxation Training (PMRT) BEHAVIORAL

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

PMRT

Brief Behavioral Treatment for Insomnia (BBTI) BEHAVIORAL

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.

BBTI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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. 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shira Maguen, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shira Maguen, PhD

CONTACT

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

Joy Huggins, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical evaluator will be kept blind to treatment condition throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will conduct 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.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)