Group Therapy for Fibromyalgia:the Effectiveness of Mindfulness -Based VS Cognitive-behavioral Therapy
Condition: Fibromyalgia; PTSD; Depression; Stress; Sleep Disturbance
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      This study was conducted as part of a collaboration between the Maccabi Health Fund and Bar
      Ilan University. Fibromyalgia is a chronic pain disorder, highly co-morbid with depression,
      stress, and anxiety. the investigators aim to examine the effect of group
      cognitive-behavioral therapy (CBT) and mindfulness-based intervention (MBI) among
      fibromyalgia patients. the investigators will also examine which intervention fits which
      patient, according to one's individual characteristics, in hope that this would enable
      Maccabi to offer personalized treatment. Furthermore, the investigators wish to identify the
      underlying cognitive and psychopathological mechanisms (measured during treatment) by which
      each intervention works.
    

Detailed description: 
      Fibromyalgia is a chronic pain disorder, highly co-morbid with depression, stress, and
      anxiety. the investigators aim to examine the effect of group cognitive-behavioral therapy
      (CBT) and mindfulness-based intervention (MBI) among fibromyalgia patients. the investigators
      will also examine which intervention fits which patient, according to one's individual
      characteristics, in hope that this would enable Maccabi to offer personalized treatment.
      Furthermore, the investigators wish to identify the underlying cognitive and
      psychopathological mechanisms (measured during treatment) by which each intervention works.

      First, the investigators expect that CBT and MBI will lead to greater improvement in
      physical, psychological, and behavioral measures among fibromyalgia patients compared to
      waitlist controls. Second, the investigators expect that MBI and CBT will have a differential
      effect, so that some outcome variables will show greater improvement following one
      intervention, but not the other. Furthermore, factors such as age, illness duration, symptom
      severity, and initial psychopathology levels will affect one's level of improvement following
      these interventions. Finally, the investigators expect to identify differential mechanisms
      driving each intervention. The study is a randomized controlled trial (RCT), including 90
      fibromyalgia patients, randomly assigned to 3 conditions: (1) Group CBT (n=30), (2) MBI
      (n=30), (3) Waitlist control group, subsequently assigned to treatment (n=30). Participants
      will complete selfreport questionnaires tapping psychological (depression, stress), cognitive
      (observing negative experiences "from afar", cognitive flexibility towards pain) and physical
      (pain, body awareness) aspects, at 4 assessments: pre-/during/post- treatment, and 3 months
      after treatment.

      To date, no RCT comparing CBT and MBI for fibromyalgia was conducted. Comparing them would be
      highly important, as they are the two most notable psychological interventions for chronic
      pain conditions. This study would enable Maccabi to offer improved psychological services for
      fibromyalgia. Furthermore, group therapy may serve as an effective treatment meeting both
      Maccabi's needs (a short, economic intervention) and patients' needs (a condition-specific
      treatment, offering group support and stigma reduction).
    

Intervention name(s): cognitive behavioral group therapy; Mindfulness-based group therapy
Intervention type(s): Other; Other
Intervention description(s): A unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain; Unique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment