Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

Study Overview
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Brief Summary
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The hypothesis of the study is that group therapy in fibromyalgia patients can provide significant improvement in pain, fatigue, anxiety and depression levels and emotional expressions.

Detailed Description
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The purpose of our study; to determine the effectiveness of group psychotherapy in the treatment of Fibromyalgia Syndrome. Patients who received 9 weeks of group therapy and those who did not, at the beginning of treatment, at the end of 9 weeks and 6 months after treatment will be evaluated using The Short Form-36, Fibromyalgia Impact Questionnaire, Revised Fibromyalgia Impact Questionnaire, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Beck Depression Inventory, Beck Anxiety Inventory, Pain Beliefs Scale, Emotional Expression Questionnaire, Visual Analogue Scale, Childhood Trauma Questionnaire, 2016 Fibromyalgia Diagnostic Criteria. At the end of the study, individuals are expected to show less depressive symptoms and anxiety symptoms compared to the beginning of the study, and it is thought that their complaints about pain will decrease.

Official Title
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Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study

Conditions
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Fibromyalgia Syndrome

Intervention / Treatment
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* Other: Group Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibromyalgia Syndrome diagnosed according to 2016 Fibromyalgia Syndrome diagnostic criteria Volunteers between the ages of 18-65 Literate volunteers Volunteering to participate in group work There is no obstacle to attend the sessions regularly every week Exclusion Criteria: Who cannot participate in 9-week group therapy Under 18, over 65 years old Confused enough to not be able to complete and understand the scales given cognitively Having serious mental illness (eg Psychotic disorder, Mental Retardation etc.) Illiterate individuals

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia. | |
| Experimental: intervention group<br>Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy. | Other: Group Psychotherapy<br>* 9 week group psychotherapy, given by a psychologist trained in group psychotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain-Visual Analog Scale | Chronic musculoskeletal pain in Fibromyalgia syndrome patients, in this scale minumum value is 0, maximum value is 10, higher scores means worse outcome. | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in Depression-Beck Depression Inventory | Depression in Fibromyalgia patients | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in Anxiety-Beck Anxiety Inventory | Anxiety in Fibromyalgia patients | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Short Form (36) Health Survey | The Short Form (36) Health Survey | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in Fibromyalgia Impact Questionaire | Fibromyalgia Impact Questionaire | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in Revised Fibromyalgia Impact Questionnaire | Revised Fibromyalgia Impact Questionnaire | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in Hospital Anxiety and Depression Scale | Hospital Anxiety and Depression Scale, in this scale minumum value is 0, maximum value is 21, high scores mean worse outcome. | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in The Fatigue Severity Scale | The Fatigue Severity Scale, In this scale consisting of 9 items, each item is scored between 1 and 7 (1 = strongly disagree, 7 = totally agree) and the total score is calculated by taking the average of 9 items, high scores mean worse outcome. | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in Pain beliefs questionnaire | Pain beliefs questionnaire | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| Change in Emotional Expression Questionnaire | Emotional Expression Questionnaire | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 
| CHILDHOOD TRAUMA QUESTIONNAIRE | CHILDHOOD TRAUMA QUESTIONNAIRE | At the beginning of the study | 
| Change in 2016 Fibromyalgia Syndrome Criteria | 2016 Fibromyalgia Syndrome Criteria 2016 Fibromyalgia Diagnostic Criteria | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, group therapy, group psychotherapy, pain, depression, anxiety