Insomnia Treatment for Women Veterans

Insomnia Clinical Trial

Official title:

A Patient-Focused Approach to Insomnia Treatment for Women Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076165
• Other study ID #: IIR 13-058
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: August 31, 2018

Study information

• Verified date: May 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: August 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• Cognitive behavioral therapy for insomnia
Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View Citation

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. — View Citation

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. d — View Citation

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 Sle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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