Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia Syndrome
• Intervention / Treatment: Other: Group Psychotherapy

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmır, Turkey, 35100
    • Ege University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 15, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: pain; depression; fibromyalgia; anxiety; group therapy; group psychotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 20-6.1T/49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No