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Insomnia Treatment for Women Veterans

A Patient-Focused Approach to Insomnia Treatment for Women Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02076165
Enrollment
347
Registered
2014-03-03
Start date
2014-09-01
Completion date
2018-08-31
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

insomnia, women

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.

Interventions

BEHAVIORALAcceptance 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.

BEHAVIORALCognitive behavioral therapy for insomnia

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence With Bedtime RecommendationsFinal 7 nights of the 5-week intervention periodMinutes deviation from recommended bedtime recommendations during final week of intervention period.
Number of Participants Completing 5 Behavioral Treatment SessionsEnd of the 5-week behavioral treatment periodNumber of participants who attended and completed all 5 behavioral treatment sessions.
Adherence to Rise Time RecommendationsFinal 7-nights of the 5-week intervention periodMinutes deviation from recommended rise time during the final week of the intervention period
Non-adherence to Nighttime Stimulus ControlFinal 7-nights of the 5-week intervention periodAverage proportion of nights on which participant did not get out of bed if unable to sleep after 20 minutes awake.

Secondary

MeasureTime frameDescription
Change From Baseline to Post-Treatment in Insomnia Severity Index ScoreBaseline and 1 week after the end of the 5-week intervention periodMean 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.
Sleep Efficiency From Sleep Diary at Post-Treatment1 week after the end of the 5-week intervention periodSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.
Change From Baseline to 3-month Follow-up in Insomnia Severity Index ScoreBaseline and 3-months from randomizationMean 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.
Sleep Efficiency From Sleep Diary at 3-month Follow-up3-months after randomizationSleep 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-Treatment1 week after the end of the 5-week intervention periodSleep 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-up3-months after randomizationSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.

Countries

United States

Participant flow

Recruitment details

347 subjects were enrolled into the study (i.e., signed consent) and were administered the baseline assessment. Final eligibility determination was made after baseline assessments. Only participants who met final inclusion/exclusion criteria (after baseline) were eligible for randomization. Results are only provided for the 149 randomized subjects.

Participants by arm

ArmCount
ABC-I
Participants will participate in 5 individual sessions with a trained instructor. Behavioral treatment for insomnia-Group I: Participants will attend 5 individual sessions with a trained instructor.
74
CBT-I
Participants will participate in 5 individual sessions with a trained instructor. Behavioral treatment for insomnia-Group II: Participants will attend in 5 individual sessions with a trained instructor.
75
Total149

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up75
Overall StudyRefused follow-up assessment11

Baseline characteristics

CharacteristicABC-ICBT-ITotal
Age, Continuous47.89 years
STANDARD_DEVIATION 12.68
47.76 years
STANDARD_DEVIATION 13.53
47.82 years
STANDARD_DEVIATION 13.07
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants17 Participants34 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
57 Participants58 Participants115 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Insomnia Severity Index (ISI)14.19 units on a scale
STANDARD_DEVIATION 4.82
14.57 units on a scale
STANDARD_DEVIATION 5.12
14.38 units on a scale
STANDARD_DEVIATION 4.96
Patient Health Questionnaire-9 (PHQ-9)10.55 units on a scale
STANDARD_DEVIATION 5.67
10.28 units on a scale
STANDARD_DEVIATION 5.42
10.42 units on a scale
STANDARD_DEVIATION 5.53
PTSD Checklist for DSM-526.25 units on a scale
STANDARD_DEVIATION 21.81
25.28 units on a scale
STANDARD_DEVIATION 20.97
25.75 units on a scale
STANDARD_DEVIATION 21.32
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Black or African American
14 Participants27 Participants41 Participants
Race (NIH/OMB)
More than one race
10 Participants5 Participants15 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants1 Participants6 Participants
Race (NIH/OMB)
White
40 Participants41 Participants81 Participants
Region of Enrollment
United States
74 Participants75 Participants149 Participants
Sex: Female, Male
Female
74 Participants75 Participants149 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 740 / 75
other
Total, other adverse events
0 / 740 / 75
serious
Total, serious adverse events
0 / 740 / 75

Outcome results

Primary

Adherence to Rise Time Recommendations

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

ArmMeasureValue (MEAN)Dispersion
ABC-IAdherence to Rise Time Recommendations20.63 minutesStandard Error 3.73
CBT-IAdherence to Rise Time Recommendations23.41 minutesStandard Error 3.58
p-value: =0.5995% CI: [-12.91, 7.35]Mixed Models Analysis
Primary

Adherence With Bedtime Recommendations

Minutes deviation from recommended bedtime recommendations during final week of intervention period.

Time frame: Final 7 nights of the 5-week intervention period

ArmMeasureValue (MEAN)Dispersion
ABC-IAdherence With Bedtime Recommendations-6.43 minutesStandard Error 2.59
CBT-IAdherence With Bedtime Recommendations-5.71 minutesStandard Error 2.48
p-value: =0.84395% CI: [-7.75, 6.32]Mixed Models Analysis
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.

Time frame: Final 7-nights of the 5-week intervention period

ArmMeasureValue (MEAN)Dispersion
ABC-INon-adherence to Nighttime Stimulus Control.274 Proportion of nightsStandard Error 0.035
CBT-INon-adherence to Nighttime Stimulus Control.273 Proportion of nightsStandard Error 0.033
p-value: =0.97995% CI: [-0.093, 0.096]Mixed Models Analysis
Primary

Number of Participants Completing 5 Behavioral Treatment Sessions

Number of participants who attended and completed all 5 behavioral treatment sessions.

Time frame: End of the 5-week behavioral treatment period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ABC-INumber of Participants Completing 5 Behavioral Treatment Sessions63 Participants
CBT-INumber of Participants Completing 5 Behavioral Treatment Sessions70 Participants
Comparison: Percentage of participants who completed all 5 treatment sessions, comparing ABC-I to CBT-I.p-value: =0.12Fisher Exact
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.

Time frame: Baseline and 3-months from randomization

ArmMeasureValue (MEAN)Dispersion
ABC-IChange From Baseline to 3-month Follow-up in Insomnia Severity Index Score-8.29 score on a scaleStandard Error 0.76
CBT-IChange From Baseline to 3-month Follow-up in Insomnia Severity Index Score-7.71 score on a scaleStandard Error 0.74
p-value: =0.00890% CI: [-2.32, 1.17]Mixed Models Analysis
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.

Time frame: Baseline and 1 week after the end of the 5-week intervention period

ArmMeasureValue (MEAN)Dispersion
ABC-IChange From Baseline to Post-Treatment in Insomnia Severity Index Score-8.68 score on a scaleStandard Error 0.65
CBT-IChange From Baseline to Post-Treatment in Insomnia Severity Index Score-9.18 score on a scaleStandard Error 0.62
p-value: =0.04890% CI: [-0.98, 1.98]Mixed Models Analysis
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.

Time frame: 1 week after the end of the 5-week intervention period

ArmMeasureValue (MEAN)Dispersion
ABC-ISleep Efficiency From Actigraphy at Post-Treatment2.32 percentage of time asleepStandard Error 0.83
CBT-ISleep Efficiency From Actigraphy at Post-Treatment1.64 percentage of time asleepStandard Error 0.79
p-value: <0.00190% CI: [-1.21, 2.57]Mixed Models Analysis
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.

Time frame: 3-months after randomization

ArmMeasureValue (MEAN)Dispersion
ABC-ISleep Efficiency From Sleep Diary at 3-month Follow-up12.74 percentage of time asleepStandard Error 1.52
CBT-ISleep Efficiency From Sleep Diary at 3-month Follow-up11.98 percentage of time asleepStandard Error 1.47
p-value: 0.00390% CI: [-2.72, 4.23]Mixed Models Analysis
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.

Time frame: 1 week after the end of the 5-week intervention period

ArmMeasureValue (MEAN)Dispersion
ABC-ISleep Efficiency From Sleep Diary at Post-Treatment13.88 percentage of time asleepStandard Error 1.45
CBT-ISleep Efficiency From Sleep Diary at Post-Treatment13.47 percentage of time asleepStandard Error 1.41
p-value: =0.00490% CI: [-2.92, 3.74]Mixed Models Analysis
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.

Time frame: 3-months after randomization

ArmMeasureValue (MEAN)Dispersion
ABC-ISleep Efficiency From Wrist Actigraphy at 3-month Follow-up1.33 percentage of time asleepStandard Error 0.99
CBT-ISleep Efficiency From Wrist Actigraphy at 3-month Follow-up0.22 percentage of time asleepStandard Error 0.94
p-value: <0.00190% CI: [-1.14, 3.36]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026