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 Mini Mental State Examination (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.

Condition	Treatment or Intervention
Insomnia	Behavior: Cognitive-Behavioral Therapy

Further Study Details: 

Expected Total Enrollment:  106

Ages Eligible for Study:  21 Years   -   85 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Meet 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
• Approval of primary provider

North Carolina
      VA Medical Center, Durham,  North Carolina,  27705,  United States; Recruiting
      VA Medical Center, Durham,  North Carolina,  27705,  United States; Recruiting
      VA Medical Center, Durham,  North Carolina,  27705,  United States; Recruiting

Study ID Numbers:  IIR 00-091
Record last reviewed:  March 2005
Last Updated:  March 17, 2005
Record first received:  March 17, 2005
ClinicalTrials.gov Identifier:  NCT00105872
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08