Insomnia Treatment for Women Veterans

Study Overview
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Brief Summary
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Women Veterans have high rates of insomnia. Prior research and our preliminary findings show that insomnia impacts the health and quality of life of women Veterans and that those with insomnia prefer non-medication treatments over sleeping pills. This study compared two non-medication behavioral treatments for insomnia to determine impacts on adherence rates and sleep/wake patterns. A novel treatment, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I) was compared to standard treatment, Cognitive Behavioral Therapy for Insomnia (CBT-I). The results showed that ABC-I was non-inferior to CBT-I and adherence to the treatments was similar in both groups. These results improve the repertoire of available behavioral treatments for insomnia within VA by showing that a new treatment, called ABC-I, works as well as standard CBT-I.

Detailed Description
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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 the investigators completed the first descriptive study of sleep problems among women Veterans who receive VA Healthcare (HSRD PPO 09-282-1; PI: Martin). The investigators found high rates of insomnia (54% of respondents) and comorbid conditions that may impact treatment acceptability and delivery. The investigators 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. This study was a randomized trial to compare two non-medication behavioral treatments for insomnia. The first is a novel intervention based on Acceptance and Commitment Therapy (ACT) in addition to sleep restriction, stimulus control and sleep hygiene. this treatment is called Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). The standard treatment used as a comparator was Cognitive-Behavioral Therapy for Insomnia (CBT-I). The objectives were: 1) to compare dropout rates and adherence to behavioral recommendations between the two treatment programs, 2) to compare the effectiveness of the two treatment programs in improving sleep/wake patterns from baseline to post-treatment, and 3) to compare the maintenance of improvements in sleep/wake patterns across the two treatment programs 3-months after the end of treatment. A brief survey was mailed to women Veterans who received healthcare within 6 months from the VA Greater Los Angeles Healthcare System, and women referred for treatment of sleep disorders were also invited to participate. All women who return the survey indicating symptoms of insomnia were contacted by phone and invited to participate in the treatment study. Exclusion criteria were 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). The insomnia treatment programs were provided in 5 one-on-one sessions to women Veterans with insomnia by a trained interventionist. Women Veterans will be randomized to one of the two treatment programs (ABC-I: n=74 and CBT-I: n=75). Adherence and attrition were measured in both treatment groups. 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 was used to test for differences between groups in adherence and attrition. Equivalency/noninferiority methods were used to determine whether sleep-related outcomes are comparable between the two groups, using both intent to treat and per protocol analyses. A priori power calculations showed that there was sufficient power to identify clinically meaningful differences with 148 randomized participants.

Official Title
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A Patient-Focused Approach to Insomnia Treatment for Women Veterans

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Acceptance and the Behavioral Changes to Treat Insomnia
* Behavioral: Cognitive behavioral therapy for insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Veteran Community-dwelling Age 18 years and older Received care from VA Greater Los Angeles Healthcare System in the past six months Responses to postal survey indicate symptoms of insomnia Did not check opt-out box for further contact on postal survey Live within 50 mile radius of Sepulveda VA Ambulatory Care Center Exclusion Criteria: Unstable housing No transportation to the medical center Current pregnancy Significant health or emotional problems, or use of drugs or alcohol Untreated sleep apnea Restless legs syndrome that accounts for the sleep disturbances reported Circadian rhythm sleep disorder that accounts for the sleep disturbances reported Active substance users or in recovery with less than 90 days of sobriety Unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia) Remission of insomnia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABC-I<br>Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the new treatment being studied. | Behavioral: Acceptance and the Behavioral Changes to Treat Insomnia<br>* Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor.<br>* Other names: ABC-I;|
| Active Comparator: CBT-I<br>Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the standard care treatment. | Behavioral: Cognitive behavioral therapy for insomnia<br>* Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.<br>* Other names: CBT-I;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Completing 5 Behavioral Treatment Sessions | Number of participants who attended and completed all 5 behavioral treatment sessions. | End of the 5-week behavioral treatment period | 
| Adherence With Bedtime Recommendations | Minutes deviation from recommended bedtime recommendations during final week of intervention period. | Final 7 nights of the 5-week intervention period | 
| Adherence to Rise Time Recommendations | Minutes deviation from recommended rise time during the final week of the intervention period | Final 7-nights of the 5-week intervention period | 
| Non-adherence to Nighttime Stimulus Control | Average proportion of nights on which participant did not get out of bed if unable to sleep after 20 minutes awake. | Final 7-nights of the 5-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency From Sleep Diary at Post-Treatment | Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. | 1 week after the end of the 5-week intervention period | 
| Sleep Efficiency From Sleep Diary at 3-month Follow-up | Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. | 3-months after randomization | 
| Sleep Efficiency From Actigraphy at Post-Treatment | Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. | 1 week after the end of the 5-week intervention period | 
| Sleep Efficiency From Wrist Actigraphy at 3-month Follow-up | Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. | 3-months after randomization | 
| Change From Baseline to Post-Treatment in Insomnia Severity Index Score | Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. | Baseline and 1 week after the end of the 5-week intervention period | 
| Change From Baseline to 3-month Follow-up in Insomnia Severity Index Score | Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. | Baseline and 3-months from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, women