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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Insomnia Primary Insomnia Secondary Insomnia Behavioral: Cognitive-Behavioral Therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Behavioral Insomnia Therapy in Primary Care
Study Start Date : March 2002
Actual Study Completion Date : July 2006

Arm Intervention/treatment
Arm 1 Behavioral: Cognitive-Behavioral Therapy



Primary Outcome Measures :
  1. Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months

Secondary Outcome Measures :
  1. Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jack D. Edinger, PhD Durham VA Medical Center, Durham, NC

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105872     History of Changes
Other Study ID Numbers: IIR 00-091
First Posted: March 18, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: March 2007

Keywords provided by VA Office of Research and Development:
insomnia
cognitive behavior therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders