Behavioral Insomnia Therapy in Primary Care
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|ClinicalTrials.gov Identifier: NCT00105872|
Recruitment Status : Completed
First Posted : March 18, 2005
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Primary Insomnia Secondary Insomnia||Behavioral: Cognitive-Behavioral Therapy||Not Applicable|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Behavioral Insomnia Therapy in Primary Care|
|Study Start Date :||March 2002|
|Actual Study Completion Date :||July 2006|
|Arm 1||Behavioral: Cognitive-Behavioral Therapy|
- Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months
- Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105872
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Jack D. Edinger, PhD||Durham VA Medical Center, Durham, NC|