RECRUITINGINTERVENTIONAL

Treatments for Insomnia in Veterans With PTSD

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - current pregnancy or has a child less than 6 months of age (men and women), - active substance users or in recovery with less than 90 days of sobriety, - too ill to engage in the study procedures, - unable to self-consent to participate, - unstable housing (since we may not be able to retrieve costly and difficult to replace monitoring equipment), - severe, untreated sleep disordered breathing (AHI\>15 with excessive daytime sleepiness, or AHI\>30), - restless legs syndrome that accounts for the sleep disturbances reported, - a circadian rhythm sleep disorder that accounts for the sleep disturbances reported (including shift work sleep disorder), - unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia); - remission of insomnia symptoms prior to randomization; - current participation in prolonged exposure therapy for PTSD. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * current pregnancy or has a child less than 6 months of age (men and women), * active substance users or in recovery with less than 90 days of sobriety, * too ill to engage in the study procedures, * unable to self-consent to participate, * unstable housing (since we may not be able to retrieve costly and difficult to replace monitoring equipment), * severe, untreated sleep disordered breathing (AHI\>15 with excessive daytime sleepiness, or AHI\>30), * restless legs syndrome that accounts for the sleep disturbances reported, * a circadian rhythm sleep disorder that accounts for the sleep disturbances reported (including shift work sleep disorder), * unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia); * remission of insomnia symptoms prior to randomization; * current participation in prolonged exposure therapy for PTSD.

Treatments Being Tested

BEHAVIORAL

The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)

5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) provided by a trained instructor.

BEHAVIORAL

Cognitive-Behavioral Therapy for Insomnia

5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.

Locations (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, United States