Fibromyalgia Syndrome Clinical Trial
Official title:
Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study
Verified date | January 2023 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University Faculty of Medicine | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Arnold LM, Hudson JI, Keck PE, Auchenbach MB, Javaras KN, Hess EV. Comorbidity of fibromyalgia and psychiatric disorders. J Clin Psychiatry. 2006 Aug;67(8):1219-25. doi: 10.4088/jcp.v67n0807. — View Citation
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Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L. An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord. 2007 Mar 9;8:27. doi: 10.1186/1471-2474-8-27. — View Citation
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Clauw DJ, Arnold LM, McCarberg BH; FibroCollaborative. The science of fibromyalgia. Mayo Clin Proc. 2011 Sep;86(9):907-11. doi: 10.4065/mcp.2011.0206. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Change in Fibromyalgia Impact Questionaire | Fibromyalgia Impact Questionaire | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change in Pain beliefs questionnaire | Pain beliefs questionnaire | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | |
Secondary | Change in Emotional Expression Questionnaire | Emotional Expression Questionnaire | At the beginnning of the study ,through study completion-8th week, after study completion -6th month | |
Secondary | CHILDHOOD TRAUMA QUESTIONNAIRE | CHILDHOOD TRAUMA QUESTIONNAIRE | At the beginning of the study | |
Secondary | 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 |
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