Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

NCT04517929 | Completed

• 1 other identifier: 20-6.1T/49
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

fibromyalgia; group therapy; group psychotherapy; pain; depression; anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Change in 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

  At the beginnning of the study ,through study completion-8th week, after study completion -6th month

• Change in 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

  At the beginnning of the study ,through study completion-8th week, after study completion -6th month

• Change in The Fatigue Severity Scale

  At the beginnning of the study ,through study completion-8th week, after study completion -6th month

Study Arms (2)

control group

NO INTERVENTION

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

intervention group

EXPERIMENTAL

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

Other: Group Psychotherapy

Interventions

Group Psychotherapy OTHER

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

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine

Izmır, 35100, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 21878603 BACKGROUND

• 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.

  PMID: 25323744 BACKGROUND

• 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.

  PMID: 17349056 BACKGROUND

• 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.

  PMID: 16965199 BACKGROUND

• 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.

  PMID: 13688369 BACKGROUND

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

  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.

  PMID: 3204199 BACKGROUND

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

  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.

  PMID: 1491853 BACKGROUND

• 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.

  PMID: 8037246 BACKGROUND

• 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.

  PMID: 12615092 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain; Depression; Anxiety Disorders

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Simin HEPGULER, Prof

  Ege University

  STUDY CHAIR

• Basak DURDU AKGUN, Dr

  Ege University

  PRINCIPAL INVESTIGATOR

• Ece Cinar, Assistant Prof

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invastigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 19, 2020
• Study Start: October 20, 2020
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)