Insomnia Clinical Trial
Official title:
Behavioral Insomnia Therapy in Primary Care
Verified date | March 2007 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
Insomnia reduces quality of life, increases risks for other illnesses, and enhances health care costs/utilization. Several efficacy studies have shown that Cognitive-Behavioral Therapy (CBT) for insomnia improves sleep and diurnal complaints among highly screened samples; however, its effectiveness among �real-world� primary care patients is yet to be tested. This project is highly relevant to the VA health care mission, given the high prevalence of insomnia in middle-aged and older adults. Pilot data from this VA suggest that 40% of primary care patients report trouble sleeping.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Veteran enrolled in primary care at Durham VAMC 2. Insomnia complaint for > 1 month 3. Meet structured interview criteria for at least one DSM-IV insomnia subtype 4. Mean total wake time > 60 minutes per night 5. Provide informed consent 6. Concurrence for enrollment from primary care provider Exclusion Criteria: 1. Terminal illness 2. Acute or unstable psychiatric condition 3. Acute pain or poorly managed chronic pain 4. Not mentally competent 5. Evidence of clinically significant sleep apnea or periodic limb movement disorder 6. Refuse to provide informed consent 7. In the opinion of their MD provider, have an unstable psychiatric or medical condition that makes participation unadvisable |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Durham VA Medical Center, Durham, NC | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Edinger JD, Glenn DM, Bastian LA, Marsh GR, Dailey D, Hope TV, Young M, Shaw E, Meeks G. Daytime testing after laboratory or home-based polysomnography: comparisons of middle-aged insomnia sufferers and normal sleepers. J Sleep Res. 2003 Mar;12(1):43-52. — View Citation
Edinger JD, Means MK, Stechuchak KM, Olsen MK. A pilot study of inexpensive sleep-assessment devices. Behav Sleep Med. 2004;2(1):41-9. — View Citation
Edinger JD, Olsen MK, Stechuchak KM, Means MK, Lineberger MD, Kirby A, Carney CE. Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial. Sleep. 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months | No | ||
Secondary | Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months | No |
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