A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder

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

This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence. The study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• community-dwelling Veterans aged 18 years and older,

• received care from VAGLAHS in the prior year,

• live within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center,

• have symptoms of PTSD,

• have symptoms of insomnia.

Locations
United States
California
VA Greater Los Angeles Healthcare System, Sepulveda, CA
RECRUITING
Sepulveda
Contact Information
Primary
Jennifer L Martin, PhD
jennifer.martin@va.gov
(818) 891-7711
Backup
Diane I Lee, MSW
Diane.Lee@va.gov
(818) 891-7711
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 400
Treatments
Experimental: The ABC of Insomnia (Acceptance and the Behavioral Changes to
This is the new treatment arm that is being compared to CBT-I, standard treatment for insomnia.
Active_comparator: Cognitive-Behavioral Therapy for Insomnia
This is the standard treatment for insomnia that is being compared to the new treatment (ABCI).
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov