Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

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ClinicalTrials.gov Identifier: NCT04517929

Recruitment Status : Completed

First Posted : August 19, 2020

Last Update Posted : January 25, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Meryem Burcu Turkoglu, Ege University

Study Description

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 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
Actual Study Start Date :	October 20, 2020
Actual Primary Completion Date :	January 1, 2022
Actual Study Completion Date :	April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Fibromyalgia

MedlinePlus related topics: Anxiety Fibromyalgia

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.
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
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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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

Locations

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Turkey
Ege University Faculty of Medicine
Izmır, Turkey, 35100

Sponsors and Collaborators

Ege University

Investigators

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Study Chair:	Simin HEPGULER, Prof	Ege University
Principal Investigator:	Basak DURDU AKGUN, Dr	Ege University
Principal Investigator:	Ece Cinar, Assistant Prof	Ege University

More Information

Publications:

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.

Jones GT, Atzeni F, Beasley M, Fluss E, Sarzi-Puttini P, Macfarlane GJ. The prevalence of fibromyalgia in the general population: a comparison of the American College of Rheumatology 1990, 2010, and modified 2010 classification criteria. Arthritis Rheumatol. 2015 Feb;67(2):568-75. doi: 10.1002/art.38905.

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.

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.

BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

Hisli N. Beck Depresyon Ölçeği'nin bir Türk örnekleminde geçerlik ve güvenirliği. Psikoloji Dergisi 1988; 6:118-122.

Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

Ulusoy M, Şahin NH, Erkmen H. Turkish version of the Beck Anxiety Inventory: Psychometric properties. J Cognit Psychother 1996; 12:163- 172

Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.

Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6. doi: 10.1176/ajp.151.8.1132.

Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.

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:	January 25, 2023
Last Verified:	January 2023
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

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