The number of women Veterans is increasing due to changes in the composition of the active duty military, and understanding the healthcare needs of this growing segment of the patients we serve is critical. Insomnia complaints are more common among women than men, with a mean prevalence of over 23% among US women. Insomnia (defined as sleep disturbance that is sufficiently severe to cause distress or impact functioning), is a significant public health concern that contributes to lost productivity, psychological distress, medical morbidity, and mortality risk. In a recent paper on transformation of care for women Veterans, Yano et al. included "sleep issues" as part of the "VA Women's Health Research Agenda for the Future";however, systematic reviews of VA women's health research (2006 and 2011) did not identify any prior studies of sleep disorders among women Veterans. In 2011 we completed the first descriptive study of sleep problems among women Veterans who receive VA Healthcare (HSRD PPO 09-282-1;PI: Martin). We found high rates of insomnia (54% of respondents) and comorbid conditions that may impact treatment acceptability and delivery. We also found that women Veterans with insomnia preferred non-medication treatments over medications, and that they were most likely to access this treatment if it were delivered in individual format (rather than groups). There is a growing literature on treatment of insomnia among individuals with comorbid conditions, suggesting that insomnia treatment may lead to meaningful and durable improvements in sleep quality and other symptoms. The proposed study is a randomized trial to compare a novel treatment, Acceptance of the Behavioral Changes to treat Insomnia (ABC-I), which combines behavioral components of Cognitive-Behavioral Therapy for Insomnia (CBT-I), with components of Acceptance and Commitment Therapy (ACT) to improve adherence to the behavioral recommendations of CBT-I. The objectives are: 1) to compare dropout rates and adherence to behavioral recommendations between the ABC-I program and a similarly-structured CBT-I program, 2) to compare the effectiveness of the ABC-I in improving sleep/wake patterns from baseline to post-treatment to a similarly-structured CBT-I program, and 3) to compare the maintenance of improvements in sleep/wake patterns across the two treatment programs 3-months after the end of treatment. Women with insomnia will be identified using methods developed in our previous pilot study. A brief survey will be mailed to approximately 5,000 women Veterans who have received healthcare within 6 months from the VA Greater Los Angeles Healthcare System. All women who return the survey indicating symptoms of insomnia will be contacted by phone and invited to participate in the treatment study. Exclusion criteria will be limited to severe or unstable medical/psychiatric disorders, the presence of moderate-to-severe sleep apnea, or barriers to attending the treatment sessions (e.g., live too far away, no access to transportation). ABC-I will be provided in 5 one-on-one sessions to women Veterans with insomnia by a trained interventionist (n=74) and will be compared to a similarly-structured CBT-I program (n=74). Adherence and attrition will be measured in both conditions. Sleep quality (self-reported and objectively measured), psychiatric symptom severity and quality of life will be assessed at baseline, post-treatment and at 3-month follow-up. ANOVA will be used to test for differences between groups in adherence and attrition. Equivalency/noninferiority methods will be used to determine whether sleep-related outcomes for ABC-I are comparable to CBT-I, using both intent to treat and per protocol analyses. With the proposed sample size, we will have sufficient power to test the study hypotheses.

Public Health Relevance

Women Veterans disproportionately suffer from insomnia, often in the context of comorbid psychiatric disorders. Prior research and our preliminary findings show that insomnia impacts health and quality of life of women Veterans and that those with insomnia prefer non-medication treatments over sleeping pills. The proposed study will test a novel non-medication insomnia treatment - the Acceptance and Behavioral Changes to treat Insomnia (ABC-I) program. If effective, ABC-I will represent a treatment option that is consistent with the preferences of women Veterans with insomnia and directly targets barriers to adherence that are specific to this population. The results of this study will ultimately improve the repertoire of available behavioral treatments for insomnia within VA and improve important health and quality of life outcomes among women Veterans who receive VA healthcare.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
1I01HX001287-01A1
Application #
8675706
Study Section
HSR-2 Determinants of Patient Response to Care (HSR2)
Project Start
2014-04-01
Project End
2018-03-31
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
VA Greater Los Angels Healthcare System
Department
Type
DUNS #
066689118
City
Los Angeles
State
CA
Country
United States
Zip Code
90073