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Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04517929
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Meryem Burcu Turkoglu, Ege University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Syndrome Other: Group Psychotherapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Fibromyalgia

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




Primary Outcome Measures :
  1. Change in Pain-Visual Analog Scale [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Chronic musculoskeletal pain in Fibromyalgia syndrome patients, in this scale minumum value is 0, maximum value is 10, higher scores means worse outcome.

  2. Change in Depression-Beck Depression Inventory [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Depression in Fibromyalgia patients

  3. Change in Anxiety-Beck Anxiety Inventory [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Anxiety in Fibromyalgia patients


Secondary Outcome Measures :
  1. Change in The Short Form (36) Health Survey [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    The Short Form (36) Health Survey

  2. Change in Fibromyalgia Impact Questionaire [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Fibromyalgia Impact Questionaire

  3. Change in Revised Fibromyalgia Impact Questionnaire [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Revised Fibromyalgia Impact Questionnaire

  4. Change in Hospital Anxiety and Depression Scale [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Hospital Anxiety and Depression Scale, in this scale minumum value is 0, maximum value is 21, high scores mean worse outcome.

  5. Change in The Fatigue Severity Scale [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    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.

  6. Change in Pain beliefs questionnaire [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Pain beliefs questionnaire

  7. Change in Emotional Expression Questionnaire [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]
    Emotional Expression Questionnaire

  8. CHILDHOOD TRAUMA QUESTIONNAIRE [ Time Frame: At the beginning of the study ]
    CHILDHOOD TRAUMA QUESTIONNAIRE

  9. Change in 2016 Fibromyalgia Syndrome Criteria [ Time Frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month ]

    2016 Fibromyalgia Syndrome Criteria

    2016 Fibromyalgia Diagnostic Criteria




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517929


Contacts
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Contact: Meryem Burcu TURKOGLU 00905077974838 meryemburcu.turkoglu@gmail.com

Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Simin HEPGULER Ege University
Principal Investigator: Basak DURDU AKGUN Ege University
Publications:
Hisli N. Beck Depresyon Ölçeği'nin bir Türk örnekleminde geçerlik ve güvenirliği. Psikoloji Dergisi 1988; 6:118-122.
Ulusoy M, Şahin NH, Erkmen H. Turkish version of the Beck Anxiety Inventory: Psychometric properties. J Cognit Psychother 1996; 12:163- 172
Kuzucu Y. , "Duyguları İfade Etme Ölçeği'nin Uyarlanması: Geçerlik Ve Güvenirlik Çalışmaları" Kastamonu Eğitim Dergisi, Cilt:19 No:3, 2011,779-792.

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Responsible Party: Meryem Burcu Turkoglu, Principal invastigator, Ege University
ClinicalTrials.gov Identifier: NCT04517929    
Other Study ID Numbers: 20-6.1T/49
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meryem Burcu Turkoglu, Ege University:
fibromyalgia
group therapy
group psychotherapy
pain
depression
anxiety
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases