RECRUITING

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder

Quick Facts

Study Start:2023-05-01
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05780177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals between the ages of 18-75 years who served in the military
  2. * Veterans who meet DSM-5 Criteria for Insomnia Disorder.
  3. * Veterans who meet DSM-5 Criteria for current PTSD
  4. * 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.
  5. * 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.
  6. * 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.
  7. * 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.
  8. * The investigators will not exclude individuals with treated sleep apnea or untreated mild sleep apnea.
  1. * Veterans with a lifetime history of psychotic disorder or manic episodes.
  2. * Veterans with moderate to severe alcohol or substance use disorder.
  3. * 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.
  4. * Veterans who are pregnant
  5. * Veterans who work night or rotating shifts
  6. * Veterans with unstable housing
  7. * Veterans with untreated moderate to severe obstructive sleep apnea (OSA)
  8. * Veterans with untreated medical conditions that are known to affect sleep (e.g., restless legs syndrome)

Contacts and Locations

Study Contact

Shira Maguen, PhD
CONTACT
(415) 221-4810
shira.maguen@va.gov
Joy Huggins, MA
CONTACT
(415) 221-4810
Joy.Huggins@va.gov

Principal Investigator

Shira Maguen, PhD
PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA

Study Locations (Sites)

San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Shira Maguen, PhD, PRINCIPAL_INVESTIGATOR, San Francisco VA Medical Center, San Francisco, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Insomnia

Additional Relevant MeSH Terms

  • Posttraumatic Stress Disorder
  • Insomnia Disorder