NCT00000397

Brief Summary

This study tests the effectiveness of a nondrug treatment for the insomnia that often occurs in people with fibromyalgia. The treatment is a type of psychotherapy called cognitive-behavioral therapy. Cognitive-behavioral therapy combines cognitive therapy, which can modify or eliminate thought patterns contributing to the person's symptoms, and behavioral therapy, which aims to help the person change his or her behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 1999

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

July 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

July 21, 2014

Status Verified

December 1, 2005

First QC Date

November 3, 1999

Last Update Submit

July 18, 2014

Conditions

FibromyalgiaInsomnia

Keywords

FibromyalgiaInsomniaCognitive-behavioral therapy (CBT)Behavioral insomnia therapy

Interventions

Behavioral insomnia therapyBEHAVIORAL

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insomnia for more than 1 month
  • Fibromyalgia diagnosis
  • Participants must live within easy commuting distance of Duke Medical Center, Durham, North Carolina

You may not qualify if:

  • Terminal illness
  • Major psychiatric disorder
  • Substance abuse
  • Dependence on hypnotic drugs
  • Other sleep disorders (sleep apnea, restless legs, etc.)
  • Other sleep-disturbing medical disorders (painful arthritis, thyroid condition, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • Krystal AD, Edinger J, Wohlgemuth W, Marsh GR. Sleep in peri-menopausal and post-menopausal women. Sleep Med Rev. 1998 Nov;2(4):243-53. doi: 10.1016/s1087-0792(98)90011-9.

    PMID: 15310495BACKGROUND

  • Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.

    PMID: 16314551RESULT

MeSH Terms

Conditions

FibromyalgiaSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Jack D. Edinger, PhD

    VA Medical Center-Durham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1999

Study Completion

September 1, 2004

Last Updated

July 21, 2014

Record last verified: 2005-12

Locations

US(1)