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Insomnia Treatment for Women Veterans

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02076165
First received: February 27, 2014
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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. The proposed study will compare two non-medication behavioral treatments for insomnia to determine impacts on adherence rates and sleep/wake patterns. The results of this study will ultimately improve the repertoire of available behavioral treatments for insomnia within VA and improve important health and quality of life outcomes among women Veterans who receive VA healthcare.


Condition Intervention
Insomnia
Behavioral: Behavioral treatment for insomnia-Group I
Behavioral: Behavioral treatment for insomnia-Group II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Patient-Focused Approach to Insomnia Treatment for Women Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Adherence with behavioral treatment for insomnia [ Time Frame: 3 months after end of treatment ] [ Designated as safety issue: No ]
    Adherence to behavioral recommendations and attrition will be measured.


Secondary Outcome Measures:
  • Sleep/wake patterns [ Time Frame: 3 months following randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABC-I
Participants will participate in 5 individual sessions with a trained instructor.
Behavioral: Behavioral treatment for insomnia-Group I
Participants will attend 5 individual sessions with a trained instructor.
Active Comparator: CBT-I
Participants will participate in 5 individual sessions with a trained instructor.
Behavioral: Behavioral treatment for insomnia-Group II
Participants will attend in 5 individual sessions with a trained instructor.

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 we completed the first descriptive study of sleep problems among women Veterans who receive VA Healthcare (HSRD PPO 09-282-1; PI: Martin). We found high rates of insomnia (54% of respondents) and comorbid conditions that may impact treatment acceptability and delivery. We 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.

The proposed study is a randomized trial to compare two non-medication behavioral treatments for insomnia. The objectives are: 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 will be mailed to approximately 5,000 women Veterans who have received healthcare within 6 months from the VA Greater Los Angeles Healthcare System. All women who return the survey indicating symptoms of insomnia will be contacted by phone and invited to participate in the treatment study. Exclusion criteria will be 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 will be 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 (n=74 in each group). Adherence and attrition will be 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 will be used to test for differences between groups in adherence and attrition. Equivalency/noninferiority methods will be used to determine whether sleep-related outcomes are comparable between the two groups, using both intent to treat and per protocol analyses. With the proposed sample size, we will have sufficient power to test the study hypotheses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female Veteran
  • Community-dwelling
  • Age 18 years
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076165

Contacts
Contact: Jennifer Martin, PhD (818) 891-7711 ext 9173 jennifer.martin@va.gov
Contact: Karen J Camacho, MPH (818) 891-7711 ext 9167 Karen.Camacho@va.gov

Sponsors and Collaborators
Investigators
Principal Investigator: Jennifer Martin, PhD VA Greater Los Angeles Healthcare System, Sepulveda, CA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02076165     History of Changes
Other Study ID Numbers: IIR 13-058
Study First Received: February 27, 2014
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
insomnia
women

ClinicalTrials.gov processed this record on September 18, 2014