Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

Not Applicable

Completed

• Conditions: Fibromyalgia Syndrome
• Interventions: Other: Group Psychotherapy

• Registration Number: NCT04517929
• Lead Sponsor: Ege University

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.

Study Timeline

• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-08-15
• Study First Posted: 2020-08-19
• Study Start: 2020-10-20
• Primary Completion: 2022-01-01
• Study Completion: 2022-04-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-22
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Group Psychotherapy	Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy.

Primary Outcome Measures

Name	Time	Method
Change in Pain-Visual Analog Scale	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Chronic musculoskeletal pain in Fibromyalgia syndrome patients, in this scale minumum value is 0, maximum value is 10, higher scores means worse outcome.
Change in Depression-Beck Depression Inventory	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Depression in Fibromyalgia patients
Change in Anxiety-Beck Anxiety Inventory	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Anxiety in Fibromyalgia patients

Secondary Outcome Measures

Name	Time	Method
Change in Revised Fibromyalgia Impact Questionnaire	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Revised Fibromyalgia Impact Questionnaire
Change in Emotional Expression Questionnaire	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Emotional Expression Questionnaire
Change in The Short Form (36) Health Survey	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	The Short Form (36) Health Survey
Change in The Fatigue Severity Scale	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	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.
CHILDHOOD TRAUMA QUESTIONNAIRE	At the beginning of the study	CHILDHOOD TRAUMA QUESTIONNAIRE
Change in Fibromyalgia Impact Questionaire	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Fibromyalgia Impact Questionaire
Change in Hospital Anxiety and Depression Scale	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Hospital Anxiety and Depression Scale, in this scale minumum value is 0, maximum value is 21, high scores mean worse outcome.
Change in Pain beliefs questionnaire	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	Pain beliefs questionnaire
Change in 2016 Fibromyalgia Syndrome Criteria	At the beginnning of the study ,through study completion-8th week, after study completion -6th month	2016 Fibromyalgia Syndrome Criteria; 2016 Fibromyalgia Diagnostic Criteria

Trial Locations

Locations (1)

Ege University Faculty of Medicine; 🇹🇷 Izmır, Turkey