Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
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• 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.

Locations
United States
California
San Francisco VA Medical Center, San Francisco, CA
RECRUITING
San Francisco
Contact Information
Primary
Shira Maguen, PhD
shira.maguen@va.gov
(415) 221-4810
Backup
Joy Huggins, MA
Joy.Huggins@va.gov
(415) 221-4810
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 200
Treatments
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).
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov