FibromyalgiaNCT04265196
Group Therapy for Fibromyalgia:the Effectiveness of Mindfulness -Based VS Cognitive-behavioral Therapy
A study testing cognitive behavioral group therapy and Mindfulness-based group therapy in people with Fibromyalgia and PTSD, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia, PTSD, Depression
- What is being tested?
- cognitive behavioral group therapy and Mindfulness-based group therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Apr 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with fibromyalgia
- Hebrew speakers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group Therapy for Fibromyalgia: RCT Testing the Effectiveness of Mindfulness -Based Therapy Versus 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.
Read the 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
- Being tested
- cognitive behavioral group therapy, Mindfulness-based group therapy
- Medical subject headings
- Fibromyalgia, Stress Disorders, Post-Traumatic, Depression, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral group therapyOther
A unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain
Mindfulness-based group therapyOther
Unique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: change through study completion, an average of 6 month
Secondary outcomes (10)
Mindfulness (Five Fact Mindfulness Questionnaire)
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
Measured: change through study completion, an average of 6 month
Psychological Inflexibility in Pain (PIPS)
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.
Measured: change through study completion, an average of 6 month
Body Vigilance (BVS)
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.
Measured: change through study completion, an average of 6 month
Meta-cognition (MCQ-30)
A self-report questionnaire designed to test metacognitive ability, with an emphasis on beliefs, judgment, and regulation.
Measured: change through study completion, an average of 6 month
Difficulties in emotion regulation (DERS)
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
Measured: change through study completion, an average of 6 month
Pain Catastrophizing (PCS)
A questionnaire examining the tendency to intensify the threat and sense of helplessness arising from pain, and the inability to prevent it
Measured: change through study completion, an average of 6 month
Trauma Exposure (The Life Events Checklist)
An index that examines exposure to traumatic life events. Exposure is rated at various levels (direct, indirect, experience)
Measured: Pre-treatment
Self- Compassion (SCS)
Self-report questionnaire that examines the participant's compassionate ability. The questionnaire refers to 3 components of compassion - Self-Kindness, Common Humanity and Mindfulness
Measured: change through study completion, an average of 6 month
Distress tolerance
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
Measured: change through study completion, an average of 6 month
Alexithymia
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.
Measured: change through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start4 Apr 2019
- Primary completion1 Oct 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Principal investigator, Danny Horesh, Bar-Ilan University, Israel
- Investigators
- Danny Horesh, Phd, Principal investigator, Bar Ilan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265196
- Sponsor's protocol ID
- 10112019
- Status last verified
- Oct 2022
- First submitted
- 2 Feb 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Therapy for Fibromyalgia: RCT Testing the Effectiveness of Mindfulness -Based Therapy Versus Cognitive-behavioral Therapy
- ClinicalTrials.gov ID
- NCT04265196
- Acronym / sponsor ID
- 10112019
- Conditions
- Fibromyalgia, PTSD, Depression, Stress, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral group therapy | Experimental | Other: cognitive behavioral group therapyA 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. |
| Mindfulness-based group therapy | Experimental | Other: Mindfulness-based group therapyA 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with fibromyalgia
- Hebrew speakers
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral group therapyA unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain | Other | cognitive behavioral group therapy |
| Mindfulness-based group therapyUnique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain | Other | Mindfulness-based group therapy |
Primary outcome
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
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 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.
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.
10 secondary outcomes
Mindfulness (Five Fact Mindfulness Questionnaire)
Time frame: change through study completion, an average of 6 month
Psychological Inflexibility in Pain (PIPS)
Time frame: change through study completion, an average of 6 month
Body Vigilance (BVS)
Time frame: change through study completion, an average of 6 month
Meta-cognition (MCQ-30)
Time frame: change through study completion, an average of 6 month
Difficulties in emotion regulation (DERS)
Time frame: change through study completion, an average of 6 month
Pain Catastrophizing (PCS)
Time frame: change through study completion, an average of 6 month
Trauma Exposure (The Life Events Checklist)
Time frame: Pre-treatment
Self- Compassion (SCS)
Time frame: change through study completion, an average of 6 month
Distress tolerance
Time frame: change through study completion, an average of 6 month
Alexithymia
Time frame: change through study completion, an average of 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Horesh, Phd principal investigator
Bar Ilan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral group therapy and Mindfulness-based group therapy in people with Fibromyalgia and PTSD, run by Bar-Ilan University, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fibromyalgia Impact Questionnaire Revised (FIQR) (time frame: change through study completion, an average of 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.