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

NCT ID: NCT04265196

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2022-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cognitive behavioral group therapy

A Cognitive Behavioral Therapy intervention is based on a unique protocol built in the light of previous research in the field and includes a 10-week treatment focused on coping with pain and stress.

Group Type: EXPERIMENTAL

cognitive behavioral group therapy

Intervention Type: OTHER

A unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain

Mindfulness-based group therapy

A mindfulness-based group therapy intervention was built inspired by a mindfulness protocol that is effective in treating pain, and includes adjustments to the physical distress of fibromyalgia patients as well as an emphasis on coping with stress and pain.

Group Type: EXPERIMENTAL

Mindfulness-based group therapy

Intervention Type: OTHER

Unique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain

control group

A control group will wait for 3 months, during which the subjects will complete the questionnaires and only after the end of the period will they participate in the treatment so that it will serve as a control group without intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cognitive behavioral group therapy

A unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain

Intervention Type: OTHER

Mindfulness-based group therapy

Unique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with fibromyalgia
• Hebrew speakers

Exclusion Criteria

• Patients who are actively suicidal
• Patients who suffering from psychotic status
• Patients who are chronically use addictive substances,
• Patients who had unusual cognitive or physical disability that would prevent them from participating in mindfulness exercises

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

Bar-Ilan University, Israel

OTHER

Sponsor Role: lead

Responsible Party

Danny Horesh

Senior lecturer and head of the Trauma and Stress Research Lab at Bar-Ilan University's Department of Psychology.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danny Horesh, Phd

Role: PRINCIPAL_INVESTIGATOR

Bar Ilan University

Locations

Bar Ilan University

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

10112019

Identifier Type: -

Identifier Source: org_study_id