Insomnia Treatment for Women Veterans

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.

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, the investigators will have sufficient power to test
the study hypotheses.

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