Behavioral Insomnia Therapy for Fibromyalgia
Condition: Fibromyalgia; Insomnia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Behavioral insomnia therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Fibromyalgia; Insomnia; Cognitive-behavioral therapy (CBT); Behavioral insomnia therapy