Group Therapy for Fibromyalgia: RCT Testing the Effectiveness of Mindfulness -Based Therapy Versus Cognitive-behavioral Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pain (VAS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Subjects will be assigned to the different treatment groups randomly and without receiving information about the different treatment options included in the study.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Pain (VAS)
Time Frame: change through study completion, an average of 6 month
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).
Sleep Quality (Pittsburgh Sleep Quality Index)
Time Frame: change through study completion, an average of 6 month
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.
Perceived Stress Scale (PSS)
Time Frame: change through study completion, an average of 6 month
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.
The Fibromyalgia Impact Questionnaire Revised (FIQR)
Time Frame: change through study completion, an average of 6 month
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
The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: change through study completion, an average of 6 month
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.
Secondary Outcomes
- Difficulties in emotion regulation (DERS)(change through study completion, an average of 6 month)
- Meta-cognition (MCQ-30)(change through study completion, an average of 6 month)
- Body Vigilance (BVS)(change through study completion, an average of 6 month)
- Trauma Exposure (The Life Events Checklist)(Pre-treatment)
- 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)
- Pain Catastrophizing (PCS)(change through study completion, an average of 6 month)
- Self- Compassion (SCS)(change through study completion, an average of 6 month)
- Distress tolerance(change through study completion, an average of 6 month)
- Alexithymia(change through study completion, an average of 6 month)
Investigators
Danny Horesh
Senior lecturer and head of the Trauma and Stress Research Lab at Bar-Ilan University's Department of Psychology.
Bar-Ilan University, Israel