NCT00105872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2007

First QC Date

March 17, 2005

Last Update Submit

April 6, 2015

Conditions

InsomniaPrimary InsomniaSecondary Insomnia

Keywords

insomniacognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

  • Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months

Secondary Outcomes (1)

  • Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months

Study Arms (1)

Arm 1

OTHER
Behavioral: Cognitive-Behavioral Therapy

Interventions

Cognitive-Behavioral TherapyBEHAVIORAL
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran enrolled in primary care at Durham VAMC
  • Insomnia complaint for \> 1 month
  • Meet structured interview criteria for at least one DSM-IV insomnia subtype
  • Mean total wake time \> 60 minutes per night
  • Provide informed consent
  • Concurrence for enrollment from primary care provider

You may not qualify if:

  • Terminal illness
  • Acute or unstable psychiatric condition
  • Acute pain or poorly managed chronic pain
  • Not mentally competent
  • Evidence of clinically significant sleep apnea or periodic limb movement disorder
  • Refuse to provide informed consent
  • In the opinion of their MD provider, have an unstable psychiatric or medical condition that makes participation unadvisable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related 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. doi: 10.1046/j.1365-2869.2003.00335.x.

    PMID: 12603786RESULT

  • Edinger JD, Means MK, Stechuchak KM, Olsen MK. A pilot study of inexpensive sleep-assessment devices. Behav Sleep Med. 2004;2(1):41-9. doi: 10.1207/s15402010bsm0201_4.

    PMID: 15600223RESULT

  • 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. 2009 Apr;32(4):499-510. doi: 10.1093/sleep/32.4.499.

    PMID: 19413144RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jack D. Edinger, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2005

First Posted

March 18, 2005

Study Start

March 1, 2002

Study Completion

July 1, 2006

Last Updated

April 7, 2015

Record last verified: 2007-03

Locations

US(1)