Clinical trial NCT04265196: Group Therapy for Fibromyalgia:the Effectiveness of Mindfulness -Based VS Cognitive-behavioral Therapy
Official title: Group Therapy for Fibromyalgia: RCT Testing the Effectiveness of Mindfulness -Based Therapy Versus Cognitive-behavioral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
PTSD
Depression
Stress
Sleep Disturbance
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2020-02-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: The Fibromyalgia Impact Questionnaire Revised (FIQR)
timeFrame: change through study completion, an average of 6 month
measure: Perceived Stress Scale (PSS)
timeFrame: change through study completion, an average of 6 month
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: change through study completion, an average of 6 month
measure: Pain (VAS)
timeFrame: change through study completion, an average of 6 month
measure: Sleep Quality (Pittsburgh Sleep Quality Index)
timeFrame: change through study completion, an average of 6 month
Secondary outcomes:
measure: Mindfulness (Five Fact Mindfulness Questionnaire)
timeFrame: change through study completion, an average of 6 month
measure: Psychological Inflexibility in Pain (PIPS)
timeFrame: change through study completion, an average of 6 month
measure: Body Vigilance (BVS)
timeFrame: change through study completion, an average of 6 month
measure: Meta-cognition (MCQ-30)
timeFrame: change through study completion, an average of 6 month
measure: Difficulties in emotion regulation (DERS)
timeFrame: change through study completion, an average of 6 month
measure: Pain Catastrophizing (PCS)
timeFrame: change through study completion, an average of 6 month
measure: Trauma Exposure (The Life Events Checklist)
timeFrame: Pre-treatment
measure: Self- Compassion (SCS)
timeFrame: change through study completion, an average of 6 month
measure: Distress tolerance
timeFrame: change through study completion, an average of 6 month
measure: Alexithymia
timeFrame: change through study completion, an average of 6 month
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Bar Ilan University
Study officials:
affiliation: Bar Ilan University
name: Danny Horesh, Phd
role: PRINCIPAL_INVESTIGATOR
References: