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IIR 20-283 – HSR&D Study

 
IIR 20-283
A Novel Acceptance-based Treatment for Insomnia in Veterans with Post-Traumatic Stress Disorder
Jennifer L Martin PhD
Sepulveda, CA
Funding Period: January 2022 - December 2025

Abstract

Background: Post-traumatic stress disorder (PTSD) impacts 11-20% of Veterans, and 70-88% of Veterans with PTSD have comorbid insomnia disorder. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder; however, using this approach with Veterans who have PTSD presents challenges and treatment gains are attenuated. There is emerging evidence that the theoretical underpinning and specific exercises of Acceptance and Commitment Therapy (ACT) present a viable approach to improving sleep when combined with evidence-based behavioral strategies. We have developed an ACT-based insomnia treatment, called "Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I)," which combines core behavioral components (sleep restriction, stimulus control, sleep hygiene, relaxation) with ACT-based techniques. Our preliminary work suggests ABC-I is highly effective for Veterans with PTSD. Significance/Impact: Poor sleep is experienced by up to 90% of individuals with PTSD, and typically does not resolve with PTSD treatment. Insomnia disorder is associated with a host of negative outcomes, including increased suicidal ideation, poor health and low quality of life. The current study will address this important clinical issue by evaluating the possible benefits of a novel treatment for insomnia disorder that is comorbid with PTSD. The proposal is responsive to the HSR&D Cross-Cutting Priority Area of Mental Health/PTSD. Innovation: The proposed project is innovative in several ways. It addresses a challenging issue among Veterans - sleep disturbance in the context of PTSD. ABC-I treatment is also innovative, combining known effective behavioral strategies with ACT, an evidence-based approach for depression and anxiety. The trial design allows for simultaneous superiority and non-inferiority testing and will lead to rapid adoption of this new treatment if it is effective for PTSD symptoms and non-inferior to CBT-I for sleep symptoms. Specific Aims: The proposed study has 4 specific aims: Specific Aim 1: Evaluate the benefits of ABC-I in reducing PTSD symptoms (PCL-5 score without sleep item) among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Hypothesis 1: ABC- I will result in greater reduction of PTSD symptoms compared to CBT-I at post-treatment and 6-month follow-up. Specific Aim 2: Evaluate the effectiveness of ABC-I in improving insomnia symptoms (ISI score) and sleep quality (diary-based sleep efficiency, PSQI score), among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Hypothesis 2, ABC-I will be non-inferior to CBT-I in improving insomnia symptoms and sleep quality, at post-treatment and 6-month follow-up. Exploratory Aim 3: Determine changes in ACT-related process and outcome measures from before to after ABC-I, including psychological flexibility, [experiential avoidance], mindfulness, value-consistent behavior, depression, anxiety and quality of life. Exploratory Aim 4: Explore the potential benefits of ABC-I and CBT-I in reducing suicidal ideation among Veterans with comorbid PTSD and insomnia disorder. Methodology: The proposed study will address the following PICOT question: Among Veterans with comorbid PTSD and Insomnia Disorder (population; n=200 randomized), how does ABC-I (intervention) compare to CBT- I (comparisons) in improving insomnia, PTSD symptoms and ACT-related measures (outcomes), over a 6-month follow-up period? The proposed analytic plan will simultaneously address superiority of ABC-I over CBT-I for improving PTSD symptoms and non-inferiority of ABC-I compared to CBT-I for improving insomnia symptoms. Implementation/Next Steps: The outcomes of the proposed study will be of interest to multiple stakeholders, including local sleep medicine services and the national programs targeting sleep disorders among Veterans. Findings will be disseminated across multiple pathways within and beyond VA.

External Links for this Project

NIH Reporter

Grant Number: I01HX003321-01A1
Link: https://reporter.nih.gov/project-details/10311382



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PUBLICATIONS:

None at this time.

DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Comparative Effectiveness, TRL - Applied/Translational
Keywords: PTSD
MeSH Terms: None at this time.

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