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Completed

NCT Number: NCT04265196

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

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.

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Key information

Conditions

Fibromyalgia Behavior Behavioral Symptoms Depression Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases PTSD Parasomnias Rheumatic Diseases Sleep Disturbance Sleep Wake Disorders Stress Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bar Ilan University

Ramat Gan, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral group therapy

Other

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

Mindfulness-based group therapy

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Secondary outcomes

  1. Mindfulness (Five Fact Mindfulness Questionnaire)

    Time frame: change through study completion, an average of 6 month

    The questionnaire includes 5 scales, which relate to various mindfulness factors - observing / paying attention to internal and external stimuli , the ability to verbally describe or label stimuli, behavior, non-judgmental and non-reactivity

  2. Psychological Inflexibility in Pain (PIPS)

    Time frame: change through study completion, an average of 6 month

    A questionnaire designed to assess the extent to which a person is trying to control and struggle with physical pain, as opposed to trying and accepting it, and "making friends" with him. The questionnaire includes 12 items.

  3. Body Vigilance (BVS)

    Time frame: change through study completion, an average of 6 month

    Self-report questionnaire designed to examine attention regarding normal physical processes, periodic susceptibility / rhythm sensitivity, and ability to predict physical responses. Each item in the questionnaire is rated on a 7-rank Likert scale (1 = not at all true, 7 = very true), with a higher score representing a higher body awareness.

  4. Meta-cognition (MCQ-30)

    Time frame: change through study completion, an average of 6 month

    A self-report questionnaire designed to test metacognitive ability, with an emphasis on beliefs, judgment, and regulation.

  5. Difficulties in emotion regulation (DERS)

    Time frame: change through study completion, an average of 6 month

    Self-report questionnaire designed to test difficulties in the emotional regulation process. The questionnaire contains 36 items that relate to awareness of emotions and emotional reactions

  6. Pain Catastrophizing (PCS)

    Time frame: change through study completion, an average of 6 month

    A questionnaire examining the tendency to intensify the threat and sense of helplessness arising from pain, and the inability to prevent it

  7. Trauma Exposure (The Life Events Checklist)

    Time frame: Pre-treatment

    An index that examines exposure to traumatic life events. Exposure is rated at various levels (direct, indirect, experience)

  8. Self- Compassion (SCS)

    Time frame: change through study completion, an average of 6 month

    Self-report questionnaire that examines the participant's compassionate ability. The questionnaire refers to 3 components of compassion - Self-Kindness, Common Humanity and Mindfulness

  9. Distress tolerance

    Time frame: change through study completion, an average of 6 month

    Self-report questionnaire covering four different categories: perceived ability to bear emotional distress, subjective assessment of distress, attentiveness to negative emotions, and regulation efforts to reduce distress.

    A combination of categories allows for an overall measure of distress resistance

  10. Alexithymia

    Time frame: change through study completion, an average of 6 month

    Self-Reporting Questionnaire Examining three subscales: (1) difficulty identifying feelings and distinguishing between feelings and bodily sensations in emotional activation, (2) difficulty in the verbal expression of emotions, and (3) externally oriented thinking.

Sponsors and collaborators

Lead sponsor

Bar-Ilan University, Israel

Other

Collaborators

  • Maccabi Healthcare Services, Israel

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 11, 2020
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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