Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia

Study Overview
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Brief Summary
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The main objective is to assess the efficacy of Acceptance & Commitment Therapy (ACT) in group for the treatment of fibromyalgia. The secondary aims are: 1.- To assess the cost-effectiveness of ACT and 2.- To assess the efficacy of ACT in other variables such as anxiety, depression, pain or global function. 3.- To evaluate the usefulness or electroencephalographic cordance as a prognostic variable of the treatment. HYPOTHESIS: ACT in group is effective for improvement of pain acceptance and other outcome variables (pain, anxiety, depression, global function) in fibromyalgia, and it is cost-effective. Cordance is an useful predictor of treatment efficacy in these patients. DESIGN: Multicentre, randomized, controlled study, with parallel groups, and a 6-month follow-up period. Participants will be randomly allocated to one of two conditions: 1.- Group Acceptation & Commitment Therapy or 2.- Treatment as usual by his general practitioner. Patients diagnosed of fibromyalgia, according to the American College of Rheumatology, will be recruited in primary care. Assuming an alpha=0.05 and p=80%, using two tails, and calculating 5% of refusals, it will be necessary a sample size of 55 patients for each group of patients.

Detailed Description
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The main outcome will be pain acceptance. Other outcome measures will be global function (assessed with the Fibromyalgia Impact Questionnaire, FIQ), cost-effectiveness (evaluated by the Client Service Receipt Inventory, CSRI) and electroencephalographic cordance. The mediating variables included are anxiety and depression (assessed with the Hospital Anxiety and Depression scale, HADS) and pain (measured with an analog visual scale). A psychiatric interview will be administered to the participants to diagnose Posttraumatic Stress Disorder. Statistical analysis will be carried out for intention to treat, and using the method Last Observation Carried Forward. A Repeated Measures Mixed Model will be used to study the main outcome. All calculations will be made with two tails and a significance of 0.05.

Official Title
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Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia: a Randomized, Controlled Study.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: ACT in group
* Behavioral: Improved treatment as usual by General Practitioners


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 year old Discontinuation drug treatment 7 days before the start of the trial Not having received psychological treatment previously or at least in the last 2 years Ability to understand Spanish Given consent to participate in the study Exclusion Criteria: Age: <18 year old and > 65 year old Clinical or psychological disease that, at investigator's opinion, can interfere the psychological examination or the adherence to psychotherapy (dementia, alcohol or drug abuse, psychosis, severe personality disorder)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT in group<br>Patients assigned to this arm will receive Acceptation and Commitment Therapy (ACT) in groups of 8-12 patients. Intervention has been protocolized. Therapy will be administered by two experienced therapists (psychologists). | Behavioral: ACT in group<br>* A protocol based on the main research studies describing the therapy and adapted for fibromyalgia treatment by our research group will be used. This protocol is available for the investigators. There will be 9 group sessions of 90 minutes duration each. Patients assigned to this arm will be allowed to occasionally take minor analgesics.<br>* Other names: Acceptation Committment Therapy in group.;|
| Active Comparator: Improved Treatment as usual by General practitioner<br>Patients assigned to this arm will receive treatment as usual by their General Practitioner in the Primary Care center. To enhance treatment, investigators participating in the trial will receive the Guidelines for fibromyalgia treatment in Primary Care handed by Health Service in Aragón. | Behavioral: Improved treatment as usual by General Practitioners<br>* General practitioners (GPs) will administer treatment as usual to the patients with fibromyalgia. To enhance the intervention, the Clinical Guidelines on the Treatment of Fibromyalgia approved by the Health Services of Aragon will be provided to the GPs.<br>* Other names: Improved Treatment as Usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLOBAL FUNCTION | GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used. | At baseline | 
| GLOBAL FUNCTION | GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used. | At month 3 | 
| GLOBAL FUNCTION | GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used. | At month 6 | 
| GLOBAL FUNCTION | GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used. | At month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEMOGRAPHIC AND CLINICAL DATA | It has been designed a questionnaire to collect demographic data (sex, age, marital status, education level, job, work disability) and clinical data (psychiatric medical history, disease duration, main symptoms, medical comorbidity etc) | At Baseline | 
| PAIN CATASTROPHIZING | It is described as a negative and exaggerated reaction towards painful stimulus. It is measured with the Pain Catastrophizing Scale that allows investigators to discriminate 3 sub-scales: rumination, magnification and helplessness. The Spanish validation of this scale will be used. | At Baseline | 
| ANXIETY AND DEPRESSION | They will be evaluated with the Hospital Anxiety and Depression Scale (HADS), a scale to detect anxiety and depression in people with medical diseases such as fibromyalgia. It is a 14-item self report scale in which items are scored in a Likert scale from 1 to 4. It includes 2 subscales: anxiety and depression, scored independently. The HADS has been validated in Spanish. | At Baseline | 
| PSYCHIATRIC DIAGNOSIS | The Standardized Polyvalent Psychiatric Interview (SPPI) will be used. It is a psychiatric interview developed by our research group to assess psychiatric morbidity in primary care. It allows the use of different diagnosis criteria like DSM-IV and ICD-10. The Posttraumatic stress disorder will be assessed specifically as it has been shown to be related to a worse prognosis in fibromyalgia. | At baseline | 
| PAIN | It will be assessed with The Analogue Visual Pain Scale. Pain is self-reported by the patient in a visual analogue scale from 0 (pain absence) to 100 (the worst pain anyone can ever imagine) | At baseline | 
| COST-EFFECTIVENESS ANALYSIS | COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services. | At Baseline | 
| PAIN ACCEPTANCE | Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group. | At Baseline | 
| CORDANCE | CORDANCE: the Fast Fourier Transform (FFT) will be applied to artefact-free electroencephalogram activity segments to calculate absolute and relative powers for each electrode. | At baseline | 
| PAIN CATASTROPHIZING | It is described as a negative and exaggerated reaction towards painful stimulus. It is measured with the Pain Catastrophizing Scale that allows investigators to discriminate 3 sub-scales: rumination, magnification and helplessness. The Spanish validation of this scale will be used. | At month 3 | 
| PAIN CATASTROPHIZING | It is described as a negative and exaggerated reaction towards painful stimulus. It is measured with the Pain Catastrophizing Scale that allows investigators to discriminate 3 sub-scales: rumination, magnification and helplessness. The Spanish validation of this scale will be used. | At month 6 | 
| ANXIETY AND DEPRESSION | They will be evaluated with the Hospital Anxiety and Depression Scale (HADS), a scale to detect anxiety and depression in people with medical diseases such as fibromyalgia. It is a 14-item self report scale in which items are scored in a Likert scale from 1 to 4. It includes 2 subscales: anxiety and depression, scored independently. The HADS has been validated in Spanish. | At month 3 | 
| ANXIETY AND DEPRESSION | They will be evaluated with the Hospital Anxiety and Depression Scale (HADS), a scale to detect anxiety and depression in people with medical diseases such as fibromyalgia. It is a 14-item self report scale in which items are scored in a Likert scale from 1 to 4. It includes 2 subscales: anxiety and depression, scored independently. The HADS has been validated in Spanish. | At month 6 | 
| PAIN | It will be assessed with The Analogue Visual Pain Scale. Pain is self-reported by the patient in a visual analogue scale from 0 (pain absence) to 100 (the worst pain anyone can ever imagine) | At month 3 | 
| PAIN | It will be assessed with The Analogue Visual Pain Scale. Pain is self-reported by the patient in a visual analogue scale from 0 (pain absence) to 100 (the worst pain anyone can ever imagine) | At month 6 | 
| COST-EFFECTIVENESS ANALYSIS | COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services. | At month 3 | 
| COST-EFFECTIVENESS ANALYSIS | COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services. | At month 6 | 
| COST-EFFECTIVENESS ANALYSIS | COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services. | At month 9 | 
| PAIN ACCEPTANCE | Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group. | At month 3 | 
| PAIN ACCEPTANCE | Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group. | At month 6 | 
| PAIN ACCEPTANCE | Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group. | At month 9 | 
| CORDANCE | CORDANCE: the Fast Fourier Transform (FFT) will be applied to artefact-free electroencephalogram activity segments to calculate absolute and relative powers for each electrode. | At month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, Acceptation & Commitment Therapy, randomized controlled trial