Behavioral Insomnia Therapy in Primary Care
Tracking Information | |||||
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First Received Date ICMJE | March 17, 2005 | ||||
Last Updated Date | April 23, 2012 | ||||
Start Date ICMJE | March 2002 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months | ||||
Change History | Complete list of historical versions of study NCT00105872 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Behavioral Insomnia Therapy in Primary Care | ||||
Official Title ICMJE | Behavioral Insomnia Therapy in Primary Care | ||||
Brief Summary | 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. |
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Detailed Description | Background: 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. Objectives: This project tests the incremental benefits of adding CBT to usual primary care for reducing sleep disturbance, diurnal dysfunction, quality of life concerns and health care utilization among veterans enrolled in the DVAMC Primary Care Clinics. Study hypotheses predict that patients who receive CBT along with usual care will show greater improvements in sleep, mood, and quality of life, as well as larger reductions in health care utilization than will those who receive usual care alone. Methods: This is a single-blind, randomized, parallel group, clinical effectiveness study of 106 veteran insomnia sufferers. Eligibility criteria include: meeting structured interview criteria for insomnia, mean subjective total wake time of > 60 minutes per night, mental status score > 27 on Folstein MMSE, no unstable medical or psychiatric disorder, no polysomnographic evidence of sleep apnea or periodic limb movements, and approval of primary provider. Participants are randomly assigned to CBT + Usual Care or to Usual Care Control condition which provides therapist contact but no active behavioral treatment. Measures of sleep, mood, and quality of life are obtained before and after treatment and at a 6-month follow up. Computerized utilization data is obtained for the six months preceding and following treatment. A series of multivariate and univariate statistical tests will be conducted. Status: Major activities over the past year involved ongoing recruiting and enrolling participants. The study closed to enrollment on 7/19/05. Of 357 patients who completed screening procedures, 81 were eligible and enrolled in the project. Of these, five are in the pre-treatment phase, one is in the treatment phase, and 12 are in the post-treatment phase. Fifty-one patients have completed all study procedures. Eleven patients dropped out prior to completing the study, and one patient withdrew consent. A 1-year no cost extension was requested on 7/26/05 because of unavoidable delays in subject recruitment and enrollment, and we are awaiting a response. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Cognitive-Behavioral Therapy | ||||
Study Arm (s) | Arm 1
Intervention: Behavioral: Cognitive-Behavioral Therapy |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 100 | ||||
Completion Date | July 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00105872 | ||||
Other Study ID Numbers ICMJE | IIR 00-091 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Department of Veterans Affairs | ||||
Study Sponsor ICMJE | Department of Veterans Affairs | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Department of Veterans Affairs | ||||
Verification Date | March 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |