Clinical trial NCT04517929: Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome
Official title: Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: fibromyalgia
group therapy
group psychotherapy
pain
depression
anxiety
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Pain-Visual Analog Scale
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in Depression-Beck Depression Inventory
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in Anxiety-Beck Anxiety Inventory
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Secondary outcomes:
measure: Change in The Short Form (36) Health Survey
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in Fibromyalgia Impact Questionaire
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in Revised Fibromyalgia Impact Questionnaire
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in The Fatigue Severity Scale
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in Pain beliefs questionnaire
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: Change in Emotional Expression Questionnaire
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
measure: CHILDHOOD TRAUMA QUESTIONNAIRE
timeFrame: At the beginning of the study
measure: Change in 2016 Fibromyalgia Syndrome Criteria
timeFrame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Other outcomes:
Locations:
city: Izmır
country: Turkey
facility: Ege University Faculty of Medicine
Study officials:
affiliation: Ege University
name: Simin HEPGULER, Prof
role: STUDY_CHAIR
affiliation: Ege University
name: Basak DURDU AKGUN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Ece Cinar, Assistant Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.
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.
citation: Hisli N. Beck Depresyon Ölçeği'nin bir Türk örnekleminde geçerlik ve güvenirliği. Psikoloji Dergisi 1988; 6:118-122.
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.
citation: Ulusoy M, Şahin NH, Erkmen H. Turkish version of the Beck Anxiety Inventory: Psychometric properties. J Cognit Psychother 1996; 12:163- 172
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.
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.
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.
citation: Kuzucu Y. , "Duyguları İfade Etme Ölçeği'nin Uyarlanması: Geçerlik Ve Güvenirlik Çalışmaları" Kastamonu Eğitim Dergisi, Cilt:19 No:3, 2011,779-792.