Insomnia Treatment for Women Veterans
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and the Behavioral Changes to Treat Insomnia
Cognitive behavioral therapy for insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring insomnia, women
Eligibility Criteria
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
Sites / Locations
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABC-I
CBT-I
Arm Description
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
Outcomes
Primary Outcome Measures
Number of Participants Completing 5 Behavioral Treatment Sessions
Number of participants who attended and completed all 5 behavioral treatment sessions.
Adherence With Bedtime Recommendations
Minutes deviation from recommended bedtime recommendations during final week of intervention period.
Adherence to Rise Time Recommendations
Minutes deviation from recommended rise time during the final week of the 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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02076165
First Posted
February 27, 2014
Last Updated
May 31, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02076165
Brief Title
Insomnia Treatment for Women Veterans
Official Title
A Patient-Focused Approach to Insomnia Treatment for Women Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABC-I
Arm Type
Experimental
Arm Description
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
Arm Title
CBT-I
Arm Type
Active Comparator
Arm Description
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and the Behavioral Changes to Treat Insomnia
Other Intervention Name(s)
ABC-I
Intervention Description
Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia
Other Intervention Name(s)
CBT-I
Intervention Description
Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.
Primary Outcome Measure Information:
Title
Number of Participants Completing 5 Behavioral Treatment Sessions
Description
Number of participants who attended and completed all 5 behavioral treatment sessions.
Time Frame
End of the 5-week behavioral treatment period
Title
Adherence With Bedtime Recommendations
Description
Minutes deviation from recommended bedtime recommendations during final week of intervention period.
Time Frame
Final 7 nights of the 5-week intervention period
Title
Adherence to Rise Time Recommendations
Description
Minutes deviation from recommended rise time during the final week of the intervention period
Time Frame
Final 7-nights of the 5-week intervention period
Title
Non-adherence to Nighttime Stimulus Control
Description
Average proportion of nights on which participant did not get out of bed if unable to sleep after 20 minutes awake.
Time Frame
Final 7-nights of the 5-week intervention period
Secondary Outcome Measure Information:
Title
Sleep Efficiency From Sleep Diary at Post-Treatment
Description
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.
Time Frame
1 week after the end of the 5-week intervention period
Title
Sleep Efficiency From Sleep Diary at 3-month Follow-up
Description
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.
Time Frame
3-months after randomization
Title
Sleep Efficiency From Actigraphy at Post-Treatment
Description
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.
Time Frame
1 week after the end of the 5-week intervention period
Title
Sleep Efficiency From Wrist Actigraphy at 3-month Follow-up
Description
Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.
Time Frame
3-months after randomization
Title
Change From Baseline to Post-Treatment in Insomnia Severity Index Score
Description
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.
Time Frame
Baseline and 1 week after the end of the 5-week intervention period
Title
Change From Baseline to 3-month Follow-up in Insomnia Severity Index Score
Description
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.
Time Frame
Baseline and 3-months from randomization
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Martin, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, Sepulveda, CA
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25890783
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. doi: 10.1016/j.sleep.2015.01.019. Epub 2015 Feb 12.
Results Reference
result
PubMed Identifier
25325580
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.
Results Reference
result
PubMed Identifier
28314434
Citation
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.
Results Reference
result
PubMed Identifier
27690634
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 Sleep Med. 2018 Jul-Aug;16(4):371-379. doi: 10.1080/15402002.2016.1228640. Epub 2016 Oct 3.
Results Reference
result
PubMed Identifier
33251855
Citation
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.
Results Reference
derived
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Insomnia Treatment for Women Veterans
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