We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Behavioral Insomnia Therapy in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105872
First Posted: March 18, 2005
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Insomnia Primary Insomnia Secondary Insomnia Behavioral: Cognitive-Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Behavioral Insomnia Therapy in Primary Care

Further study details as provided by VA Office of Research and Development:

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

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

Estimated Enrollment: 100
Study Start Date: March 2002
Study Completion Date: July 2006
Arms Assigned Interventions
Arm 1 Behavioral: Cognitive-Behavioral Therapy

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105872     History of Changes
Other Study ID Numbers: IIR 00-091
First Submitted: March 17, 2005
First Posted: March 18, 2005
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