Insomnia Clinical Trial
Official title:
Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 1 or more deployments to OEF or OIF - Exposure to Trauma - Nightmares 2 or more times per week - Insomnia for 1 month or more - Live in greater San Diego County region Exclusion Criteria: - Use of medications for sleep or nightmares in the past 2 weeks - Current enrollment in psychotherapy for PTSD - Current or recent substance or alcohol abuse or dependence - Other untreated sleep disorders (e.g., sleep apnea) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs San Diego Healthcare System | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | National Institute of Nursing Research (NINR), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | nightmares and insomnia symptoms | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment | No | |
Secondary | daytime (non-sleep) PTSD symptoms | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment | No | |
Secondary | health-related quality of life | pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment | No |
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