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.
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.
- Insomnia for more than 1 month
- Fibromyalgia diagnosis
- Participants must live within easy commuting distance of Duke Medical Center, Durham,
- 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.)