Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

Sponsor
Ege University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04517929
Collaborator
(none)
16
1
2
18.3
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group Psychotherapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study
Actual Study Start Date :
Oct 20, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

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

Experimental: intervention group

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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

  1. 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

  2. Change in Fibromyalgia Impact Questionaire [At the beginnning of the study ,through study completion-8th week, after study completion -6th month]

    Fibromyalgia Impact Questionaire

  3. 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

  4. 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.

  5. 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.

  6. Change in Pain beliefs questionnaire [At the beginnning of the study ,through study completion-8th week, after study completion -6th month]

    Pain beliefs questionnaire

  7. Change in Emotional Expression Questionnaire [At the beginnning of the study ,through study completion-8th week, after study completion -6th month]

    Emotional Expression Questionnaire

  8. CHILDHOOD TRAUMA QUESTIONNAIRE [At the beginning of the study]

    CHILDHOOD TRAUMA QUESTIONNAIRE

  9. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University Faculty of Medicine Izmır Turkey 35100

Sponsors and Collaborators

  • Ege University

Investigators

  • Principal Investigator: Simin HEPGULER, Ege University
  • Principal Investigator: Basak DURDU AKGUN, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Meryem Burcu Turkoglu, Principal invastigator, Ege University
ClinicalTrials.gov Identifier:
NCT04517929
Other Study ID Numbers:
  • 20-6.1T/49
First Posted:
Aug 19, 2020
Last Update Posted:
Nov 20, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Meryem Burcu Turkoglu, Principal invastigator, Ege University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 20, 2020