Behavioral Insomnia Therapy in Primary Care

Insomnia Clinical Trial

Official title:

Behavioral Insomnia Therapy in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105872
• Other study ID #: IIR 00-091
• Status: Completed
• Phase: N/A
• First received: March 17, 2005
• Last updated: April 6, 2015
• Start date: March 2002
• Est. completion date: July 2006

Study information

• Verified date: March 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Primary Insomnia
• Secondary Insomnia

Intervention

Behavioral:
• Cognitive-Behavioral Therapy

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Edinger JD, Glenn DM, Bastian LA, Marsh GR, Dailey D, Hope TV, Young M, Shaw E, Meeks G. Daytime testing after laboratory or home-based polysomnography: comparisons of middle-aged insomnia sufferers and normal sleepers. J Sleep Res. 2003 Mar;12(1):43-52. — View Citation

Edinger JD, Means MK, Stechuchak KM, Olsen MK. A pilot study of inexpensive sleep-assessment devices. Behav Sleep Med. 2004;2(1):41-9. — View Citation

Edinger JD, Olsen MK, Stechuchak KM, Means MK, Lineberger MD, Kirby A, Carney CE. Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial. Sleep. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months			No
Secondary	Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months			No