Behavioral Insomnia Therapy for Fibromyalgia

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00000397

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

106

Enrollment

Location

62.1

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 1999

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)