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Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04517929
Enrollment
24
Registered
2020-08-19
Start date
2020-10-20
Completion date
2022-04-01
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Syndrome

Keywords

fibromyalgia, group therapy, group psychotherapy, pain, depression, anxiety

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.

Interventions

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

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain-Visual Analog ScaleAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthChronic 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 InventoryAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthDepression in Fibromyalgia patients
Change in Anxiety-Beck Anxiety InventoryAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthAnxiety in Fibromyalgia patients

Secondary

MeasureTime frameDescription
Change in Hospital Anxiety and Depression ScaleAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthHospital Anxiety and Depression Scale, in this scale minumum value is 0, maximum value is 21, high scores mean worse outcome.
Change in The Fatigue Severity ScaleAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthThe 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.
Change in Pain beliefs questionnaireAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthPain beliefs questionnaire
Change in The Short Form (36) Health SurveyAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthThe Short Form (36) Health Survey
CHILDHOOD TRAUMA QUESTIONNAIREAt the beginning of the studyCHILDHOOD TRAUMA QUESTIONNAIRE
Change in 2016 Fibromyalgia Syndrome CriteriaAt the beginnning of the study ,through study completion-8th week, after study completion -6th month2016 Fibromyalgia Syndrome Criteria 2016 Fibromyalgia Diagnostic Criteria
Change in Emotional Expression QuestionnaireAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthEmotional Expression Questionnaire
Change in Fibromyalgia Impact QuestionaireAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthFibromyalgia Impact Questionaire
Change in Revised Fibromyalgia Impact QuestionnaireAt the beginnning of the study ,through study completion-8th week, after study completion -6th monthRevised Fibromyalgia Impact Questionnaire

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026