NCT04265196

Group Therapy for Fibromyalgia:the Effectiveness of Mindfulness -Based VS Cognitive-behavioral Therapy

Group Therapy for Fibromyalgia: RCT Testing the Effectiveness of Mindfulness -Based Therapy Versus Cognitive-behavioral Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Bar-Ilan University, Israel · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Fibromyalgia
• PTSD
• Depression
• Stress
• Sleep Disturbance

Interventions

Type	Name	Description
OTHER	cognitive behavioral group therapy	A unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain
OTHER	Mindfulness-based group therapy	Unique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain

Timeline

• Start date: 2019-04-04
• Primary completion: 2021-10-01
• Completion: 2022-08-31
• First posted: 2020-02-11
• Last updated: 2022-10-04

Locations

1 site across 1 country: Israel