InsomniaNCT02076165
Insomnia Treatment for Women Veterans
A study testing Acceptance and the Behavioral Changes to Treat Insomnia and Cognitive behavioral therapy for insomnia in people with Insomnia, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Acceptance and the Behavioral Changes to Treat Insomnia and Cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2014to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Acceptance and the Behavioral Changes to Treat Insomnia, Cognitive behavioral therapy for insomnia
- Keywords
- insomnia, women
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and the Behavioral Changes to Treat InsomniaBehavioural
Also called ABC-I
Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor.
Cognitive behavioral therapy for insomniaBehavioural
Also called CBT-I
Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance and the Behavioral Changes to Treat Insomnia |
| CBT-I | Active comparator | Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment. Receives: Behavioral: Cognitive behavioral therapy for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing 5 Behavioral Treatment Sessions
Number of participants who attended and completed all 5 behavioral treatment sessions.
Measured: End of the 5-week behavioral treatment period
Adherence With Bedtime Recommendations
Minutes deviation from recommended bedtime recommendations during final week of intervention period.
Measured: 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
Measured: 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.
Measured: Final 7-nights of the 5-week intervention period
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3-months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start1 Sep 2014
- Primary completion28 Feb 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer Martin, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076165
- Sponsor's protocol ID
- IIR 13-058
- Status last verified
- May 2019
- First submitted
- 27 Feb 2014
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25890783Dzierzewski 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.
PubMed 25325580Culver 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.
PubMed 28314434Song 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.
PubMed 27690634Saldana 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.
PubMed 37749876Martin 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.
PubMed 37535521Carlson 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.
PubMed 33251855
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Focused Approach to Insomnia Treatment for Women Veterans
- ClinicalTrials.gov ID
- NCT02076165
- Acronym / sponsor ID
- IIR 13-058
- Conditions
- Insomnia
- Keywords
- insomnia, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABC-I | Experimental | Behavioral: Acceptance and the Behavioral Changes to Treat InsomniaParticipants 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 | Behavioral: Cognitive behavioral therapy for insomniaParticipants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Unstable housing
- No transportation to the medical center
- Current pregnancy
- Significant health or emotional problems, or use of drugs or alcohol
- Untreated sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and the Behavioral Changes to Treat InsomniaAlso: ABC-IParticipants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor. | Behavioural | ABC-I |
| Cognitive behavioral therapy for insomniaAlso: CBT-IParticipants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor. | Behavioural | CBT-I |
Primary outcome
Number of Participants Completing 5 Behavioral Treatment Sessions
Time frame: End of the 5-week behavioral treatment period
Number of participants who attended and completed all 5 behavioral treatment sessions.
Adherence With Bedtime Recommendations
Time frame: Final 7 nights of the 5-week intervention period
Minutes deviation from recommended bedtime recommendations during final week of intervention period.
Adherence to Rise Time Recommendations
Time frame: Final 7-nights of the 5-week intervention period
Minutes deviation from recommended rise time during the final week of the intervention period
Non-adherence to Nighttime Stimulus Control
Time frame: Final 7-nights of the 5-week intervention period
Average proportion of nights on which participant did not get out of bed if unable to sleep after 20 minutes awake.
6 secondary outcomes
Sleep Efficiency From Sleep Diary at Post-Treatment
Time frame: 1 week after the end of the 5-week intervention period
Sleep Efficiency From Sleep Diary at 3-month Follow-up
Time frame: 3-months after randomization
Sleep Efficiency From Actigraphy at Post-Treatment
Time frame: 1 week after the end of the 5-week intervention period
Sleep Efficiency From Wrist Actigraphy at 3-month Follow-up
Time frame: 3-months after randomization
Change From Baseline to Post-Treatment in Insomnia Severity Index Score
Time frame: 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
Time frame: Baseline and 3-months from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25890783Fung 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 publication: PubMed 25325580Dzierzewski 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 publication: PubMed 28314434Culver 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 publication: PubMed 27690634Song 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.
- Derived from this study: PubMed 37749876Saldana 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.
- Derived from this study: PubMed 37535521Martin 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.
- Derived from this study: PubMed 33251855Carlson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Martin, PhD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and the Behavioral Changes to Treat Insomnia and Cognitive behavioral therapy for insomnia in people with Insomnia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Completing 5 Behavioral Treatment Sessions (time frame: End of the 5-week behavioral treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02076165, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.