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

NCT04265196 | Completed

• 1 other identifier: 10112019
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; PTSD; Depression; Stress; Sleep Disturbance

Outcome Measures

Primary Outcomes (5)

• The Fibromyalgia Impact Questionnaire Revised (FIQR)

  Self-report questionnaire, which includes 21 items and assesses symptoms and functioning of fibromyalgia patients, taking into account the frequency of symptoms, their intensity, and the degree of impairment of patient function

  change through study completion, an average of 6 month

• Perceived Stress Scale (PSS)

  A 10-item questionnaire measuring the level at which events occurred in the individual's life in the past month is perceived as unpredictable, uncontrollable and overwhelming. A higher score indicates a higher level of perceived stress.

  change through study completion, an average of 6 month

• The Patient Health Questionnaire-9 (PHQ-9)

  A self-reported 9-item questionnaire to measure symptoms of major depression. The items relate to the key aspects of DSM, including thoughts of death, loss of appetite, sadness and mental pain, and negative cognitions.

  change through study completion, an average of 6 month

• Pain (VAS)

  Self-report questionnaire designed to measure pain intensity and unpleasantness caused by pain. This questionnaire is widely used in pain clinics. It includes one item that can be graded on a continuous scale that ranges from 0 (no pain) to 10 (the worst pain that can be).

  change through study completion, an average of 6 month

• Sleep Quality (Pittsburgh Sleep Quality Index)

  A questionnaire developed to measure sleep quality and sleep disorder. The questionnaire includes 19 items measuring seven components of sleep (sleep quality, sleep onset, sleep duration, sleep efficiency, sleep disturbance, sleep medication use, and daily functioning impairment) over the past four weeks.

  change through study completion, an average of 6 month

Secondary Outcomes (10)

• Mindfulness (Five Fact Mindfulness Questionnaire)

  change through study completion, an average of 6 month

• Psychological Inflexibility in Pain (PIPS)

  change through study completion, an average of 6 month

• Body Vigilance (BVS)

  change through study completion, an average of 6 month

• Meta-cognition (MCQ-30)

  change through study completion, an average of 6 month

• Difficulties in emotion regulation (DERS)

  change through study completion, an average of 6 month

Study Arms (3)

cognitive behavioral group therapy

EXPERIMENTAL

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.

Other: cognitive behavioral group therapy

Mindfulness-based group therapy

EXPERIMENTAL

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.

Other: Mindfulness-based group therapy

control group

NO INTERVENTION

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.

Interventions

cognitive behavioral group therapy OTHER

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

cognitive behavioral group therapy

Mindfulness-based group therapy OTHER

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

Mindfulness-based group therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with fibromyalgia
• Hebrew speakers

You may not qualify if:

• 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

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

Bar Ilan University

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Fibromyalgia; Stress Disorders, Post-Traumatic; Depression; Parasomnias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Wake Disorders

Study Officials

• Danny Horesh, Phd

  Bar Ilan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be assigned to the different treatment groups randomly and without receiving information about the different treatment options included in the study.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer and head of the Trauma and Stress Research Lab at Bar-Ilan University's Department of Psychology.

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 11, 2020
• Study Start: April 4, 2019
• Primary Completion: October 1, 2021
• Study Completion: August 31, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

IL (1)