Insomnia Treatment for Women Veterans

A Patient-Focused Approach to Insomnia Treatment for Women Veterans

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Acceptance and the Behavioral Changes to Treat Insomnia; Behavioral: Cognitive behavioral therapy for insomnia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sepulveda, California, United States, 91343
      • VA Greater Los Angeles Healthcare System, Sepulveda, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABC-I; 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; Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor.; Other Names: ABC-I
Active Comparator: CBT-I; 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; Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.; Other Names: CBT-I

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Publications and helpful links

General Publications

• Fung CH, Martin JL, Hays RD, Rodriguez JC, Igodan U, Jouldjian S, Dzierzewski JM, Kramer BJ, Josephson K, Alessi C. Development of the Usability of Sleep Apnea Equipment-Positive Airway Pressure (USE-PAP) questionnaire. Sleep Med. 2015 May;16(5):645-51. doi: 10.1016/j.sleep.2015.01.019. Epub 2015 Feb 12.
• Dzierzewski JM, Mitchell M, Rodriguez JC, Fung CH, Jouldjian S, Alessi CA, Martin JL. Patterns and predictors of sleep quality before, during, and after hospitalization in older adults. J Clin Sleep Med. 2015 Jan 15;11(1):45-51. doi: 10.5664/jcsm.4362.
• Culver NC, Song Y, Kate McGowan S, Fung CH, Mitchell MN, Rodriguez JC, Dzierzewski JM, Josephson KR, Jouldjian S, Washington DL, Yano EM, Schweizer CA, Alessi CA, Martin JL. Acceptability of Medication and Nonmedication Treatment for Insomnia Among Female Veterans: Effects of Age, Insomnia Severity, and Psychiatric Symptoms. Clin Ther. 2016 Nov;38(11):2373-2385. doi: 10.1016/j.clinthera.2016.09.019. Epub 2016 Oct 27.
• Song Y, Washington DL, Yano EM, McCurry SM, Fung CH, Dzierzewski JM, Rodriguez JC, Jouldjian S, Mitchell MN, Alessi CA, Martin JL. Caregiving-Related Sleep Problems and Their Relationship to Mental Health and Daytime Function in Female Veterans. Behav Sleep Med. 2018 Jul-Aug;16(4):371-379. doi: 10.1080/15402002.2016.1228640. Epub 2016 Oct 3.
• Carlson GC, Kelly MR, Grinberg AM, Mitchell M, McGowan SK, Culver NC, Kay M, Alessi CA, Washington DL, Yano EM, Martin JL. Insomnia Precipitating Events among Women Veterans: The Impact of Traumatic and Nontraumatic Events on Sleep and Mental Health Symptoms. Behav Sleep Med. 2021 Sep-Oct;19(5):672-688. doi: 10.1080/15402002.2020.1846537. Epub 2020 Nov 30.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: insomnia; women
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IIR 13-058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No