Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

NCT ID: NCT04517929

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-04-01

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.

Conditions

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Fibromyalgia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia.

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy.

Group Type EXPERIMENTAL

Group Psychotherapy

Intervention Type OTHER

9 week group psychotherapy, given by a psychologist trained in group psychotherapy.

Interventions

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Group Psychotherapy

9 week group psychotherapy, given by a psychologist trained in group psychotherapy.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Meryem Burcu Turkoglu

Principal invastigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simin HEPGULER, Prof

Role: STUDY_CHAIR

Ege University

Basak DURDU AKGUN, Dr

Role: PRINCIPAL_INVESTIGATOR

Ege University

Ece Cinar, Assistant Prof

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

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Ege University Faculty of Medicine

Izmır, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21878603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25323744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17349056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16965199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13688369 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 3204199 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 1491853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8037246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12615092 (View on PubMed)

Kuzucu Y. , "Duyguları İfade Etme Ölçeği'nin Uyarlanması: Geçerlik Ve Güvenirlik Çalışmaları" Kastamonu Eğitim Dergisi, Cilt:19 No:3, 2011,779-792.

Reference Type BACKGROUND

Other Identifiers

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20-6.1T/49

Identifier Type: -

Identifier Source: org_study_id

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