Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

Fibromyalgia Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517929
• Other study ID #: 20-6.1T/49
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Other:
• Group Psychotherapy
9 week group psychotherapy, given by a psychologist trained in group psychotherapy.

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

Kuzucu Y. , "Duygulari Ifade Etme Ölçegi'nin Uyarlanmasi: Geçerlik Ve Güvenirlik Çalismalari" Kastamonu Egitim Dergisi, Cilt:19 No:3, 2011,779-792.

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

* Note: There are 12 references in all — Click here to view all references

Outcome

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