Behavioral Insomnia Therapy for Fibromyalgia

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. Identifier: NCT00000397
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 21, 2014
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Insomnia Behavioral: Behavioral insomnia therapy Not Applicable

Detailed Description:

Fibromyalgia (FM) is a prevalent and debilitating condition that contributes to impaired occupational and social functioning and increased disability among affected individuals. The vast majority of people with FM experience persistent sleep disturbances (e.g., onset difficulty, repeated or extended awakenings, nonrestorative sleep) that worsen other FM-related symptoms (e.g., chronic pain, fatigue) and sustain their general dysfunction. Pharmacologic treatments (e.g., antidepressants, hypnotics) may reduce symptoms for some people with FM, but many FM patients display little enduring improvement in their sleep and other FM-related symptoms in response to such agents.

Our clinical observations and initial pilot work suggest that factors common among other insomnia subtypes such as conditioned bedtime arousal, erratic sleep/wake scheduling, and spending too much time in bed likely perpetuate the sleep problems of these medication-refractory FM patients. Over the past decade, we have developed, refined, and repeatedly tested a cognitive-behavioral therapy (CBT) that has proven effective for reducing sleep disturbances perpetuated by such underlying cognitive/behavioral mechanisms. The major objectives of this project are to conduct a prospective randomized clinical trial to confirm these preliminary findings and to determine the efficacy of CBT insomnia treatment for interrupting the disturbed nocturnal sleep and daytime pain, fatigue, and distress symptom complex that defines FM.

One arm of this study's three-by-four factorial design will compare CBT with both a contact control treatment and standard care. The other arm in the design is a repeated-measures factor consisting of four time points (i.e., baseline, mid-treatment, post-treatment, and 6-month follow-up periods) at which we will assess outcome. We will assess participants at all four time points with objective (wrist actigraphy) and subjective (sleep logs, Insomnia Symptom Questionnaire) measures of sleep improvements, measures of subjective pain, and questionnaires that assess mood (State-Trait Anxiety and Beck Depression Scales) and general quality of life (SF-36). We will conduct multivariate statistical analyses and tests of clinical significance with these various measures. We will also conduct exploratory analyses to determine if polysomnographically-derived sleep measures obtained prior to treatment correlate with initial levels of pain and distress or eventual treatment outcome.

Results should provide information about the usefulness of CBT for treating FM-related sleep difficulties. Results should also improve understanding of the FM syndrome in general and provide new information about the potential role of behavioral therapy in the overall management of this disorder.

Individuals interested in participating in this study should live within reasonable commuting distance from the Duke University Medical Center (Durham, NC), because this research requires multiple outpatient visits for screening and treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Behavioral Insomnia Therapy for Fibromyalgia Patients
Study Start Date : July 1999
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.)

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 identifier (NCT number): NCT00000397

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Jack D. Edinger, PhD VA Medical Center-Durham

Publications of Results:
Other Publications:
Responsible Party: Duke University Identifier: NCT00000397     History of Changes
Other Study ID Numbers: Pro00008633
R21AR046094 ( U.S. NIH Grant/Contract )
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: December 2005

Keywords provided by Duke University:
Cognitive-behavioral therapy (CBT)
Behavioral insomnia therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Myofascial Pain Syndromes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases