Insomnia Clinical Trial
Official title:
Behavioral Insomnia Therapy in Primary Care
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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