Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
Condition: Fibromyalgia; Sleep Initiation and Maintenance Disorders
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain,
      fatigue, and multiple tender points. The majority of individuals with FM report sleep
      problems, including delayed sleep onset, extended awakenings, and non-restorative sleep.
      These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The
      purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia
      therapy in reducing sleep disturbances and improving other FM-related symptoms.
    

Detailed description: 
      FM is a debilitating condition that can lead to impaired occupational and social functioning,
      disability, and increased health care utilization. FM symptoms vary among individuals, but
      they typically include chronic widespread pain, persistent daytime fatigue, sleep
      disturbances, low mood, and loss of stamina. The cause of FM remains unknown, and current
      treatment involves symptom-focused interventions such as antidepressants, behavioral stress
      management, coping skills training, and exercise programs. However, there are no
      interventions specifically designed to reduce sleep disturbances in people with FM.

      Past research has shown that individuals with FM experience the same behavioral and
      psychological factors that individuals suffering from insomnia experience. Cognitive
      behavioral insomnia therapy, a form of psychotherapy that aims to eliminate factors that
      disrupt sleep, may prove useful for people with FM. The purpose of this study is to evaluate
      the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and
      improving FM-related pain, fatigue, mood, and quality of life among individuals with FM. The
      study will also examine the use of sleep electroencephalogram (EEG) as a means to measure
      improvements in FM symptoms.

      This study will last about 9 months and will include approximately 16 study visits. An
      initial 2-week screening period will include a physical examination, blood collection, a
      mental status exam, a tender-point exam, a sleep history questionnaire, and structured sleep
      and psychiatric interviews. Participants will complete a 1-week sleep log and one overnight
      polysomnogram test, in which several body functions (e.g., brain activity, eye movement,
      heart rate, etc.) are recorded. If an FM diagnosis is confirmed, an additional 2-week
      assessment period will take place, followed by an 8-week treatment period. During treatment,
      participants will be randomly assigned to one of the following three treatment groups: 1)
      usual FM care (medical advice and medication prescription), 2) usual FM care plus
      psychological treatment to decrease insomnia, and 3) usual FM care plus placebo psychological
      treatment to decrease insomnia. Groups 2 and 3 will attend four bi-weekly individual therapy
      sessions with a sleep psychologist. Participants will meet with a rheumatologist at least
      once. Throughout treatment, nightly sleep logs and medication questionnaires will be
      completed, and participants will wear a wrist-watch sized device that will record their day-
      and night-time activity. A therapy evaluation questionnaire will be completed during the
      first and last weeks of treatment and an outcome questionnaire packet will be completed after
      4 weeks of treatment. All participants will be evaluated following the end of treatment and
      again 6 months later.
    

Intervention name(s): Cognitive behavioral therapy for insomnia; Pseudo-desensitization procedure; Usual care
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 4 biweekly outpatient sessions with sleep psychologist; 4 biweekly outpatient visits with sleep psychologist; 3 outpatient visits with study physician
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insomnia; cognitive behavior therapy