Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC-I | Experimental | Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied. |
|
| CBT-I | Active Comparator | Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and the Behavioral Changes to Treat Insomnia | Behavioral | Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Martin, PhD | VA Greater Los Angeles Healthcare System, Sepulveda, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, Sepulveda, CA | Sepulveda | California | 91343 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25890783 | Result | 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. | |
| 25325580 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABC-I | 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. |
| FG001 | CBT-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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | CBT-I |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Completing 5 Behavioral Treatment Sessions | Number of participants who attended and completed all 5 behavioral treatment sessions. | Posted | Count of Participants | Participants | End of the 5-week behavioral treatment period |
|
Adverse event data was collected for 3 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Martin | VA Greater Los Angeles Healthcare System | 818 891-7711 | 36080 | Jennifer.Martin@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2016 | Feb 13, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2017 | Feb 14, 2019 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cognitive behavioral therapy for insomnia | Behavioral | Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor. |
|
|
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 |
| 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. |
| 28314434 | Result | 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. |
| 27690634 | Result | 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. |
| 37749876 | Derived | Saldana KS, Carlson GC, Revolorio K, Kelly MR, Josephson KR, Mitchell MN, Culver N, Kay M, McGowan SK, Song Y, Deleeuw C, Martin JL. Values Expressed by Women Veterans Receiving Treatment for Chronic Insomnia Disorder. Behav Sleep Med. 2024 May-Jun;22(3):340-352. doi: 10.1080/15402002.2023.2260517. Epub 2023 Sep 25. |
| 37535521 | Derived | Martin JL, Carlson GC, Kelly MR, Song Y, Mitchell MN, Josephson KR, McGowan SK, Culver NC, Kay MA, Erickson AJ, Saldana KS, May KJ, Fiorentino L, Alessi CA, Washington DL, Yano EM. Novel treatment based on acceptance and commitment therapy versus cognitive behavioral therapy for insomnia: A randomized comparative effectiveness trial in women veterans. J Consult Clin Psychol. 2023 Nov;91(11):626-639. doi: 10.1037/ccp0000836. Epub 2023 Aug 3. |
| 33251855 | Derived | 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. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insomnia Severity Index (ISI) | The Insomnia Severity Index (ISI) is a 7-item scale instrument that measures perceived severity of insomnia symptoms. Score ranges from 0 to 28, with higher scores indicating greater insomnia severity. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a 9-item depression module in the Patient Health Questionnaire (a self-administered diagnostic instrument for common mental disorders) which is part of the Primary Care Evaluation of Mental Disorders (PRIME-MD) suite of evaluation tools. Scores range from 0 to 27 with higher scores indicating greater depression symptom severity. | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist for DSM-5 | The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Scores range from 0 to 80 with higher scores indicating greater severity of PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Adherence With Bedtime Recommendations | Minutes deviation from recommended bedtime recommendations during final week of intervention period. | Posted | Mean | Standard Error | minutes | 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 | Posted | Mean | Standard Error | minutes | 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. | Posted | Mean | Standard Error | Proportion of nights | 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. | Posted | Mean | Standard Error | percentage of time asleep | 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. | Posted | Mean | Standard Error | percentage of time asleep | 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. | Posted | Mean | Standard Error | percentage of time asleep | 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. | Posted | Mean | Standard Error | percentage of time asleep | 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. | Posted | Mean | Standard Error | score on a scale | 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 3-months from randomization |
|
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | CBT-I | Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment. | 0 | 75 | 0 | 75 | 0 | 75 |
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |