Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring fibromyalgia, group therapy, group psychotherapy, pain, depression, anxiety
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
Sites / Locations
- Ege University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
intervention group
Arm Description
Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia.
Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy.
Outcomes
Primary Outcome Measures
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.
Change in Depression-Beck Depression Inventory
Depression in Fibromyalgia patients
Change in Anxiety-Beck Anxiety Inventory
Anxiety in Fibromyalgia patients
Secondary Outcome Measures
Change in The Short Form (36) Health Survey
The Short Form (36) Health Survey
Change in Fibromyalgia Impact Questionaire
Fibromyalgia Impact Questionaire
Change in Revised Fibromyalgia Impact Questionnaire
Revised Fibromyalgia Impact Questionnaire
Change in Hospital Anxiety and Depression Scale
Hospital 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 Scale
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.
Change in Pain beliefs questionnaire
Pain beliefs questionnaire
Change in Emotional Expression Questionnaire
Emotional Expression Questionnaire
CHILDHOOD TRAUMA QUESTIONNAIRE
CHILDHOOD TRAUMA QUESTIONNAIRE
Change in 2016 Fibromyalgia Syndrome Criteria
2016 Fibromyalgia Syndrome Criteria
2016 Fibromyalgia Diagnostic Criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04517929
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome
Keywords
fibromyalgia, group therapy, group psychotherapy, pain, depression, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia.
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy.
Intervention Type
Other
Intervention Name(s)
Group Psychotherapy
Intervention Description
9 week group psychotherapy, given by a psychologist trained in group psychotherapy.
Primary Outcome Measure Information:
Title
Change in Pain-Visual Analog Scale
Description
Chronic musculoskeletal pain in Fibromyalgia syndrome patients, in this scale minumum value is 0, maximum value is 10, higher scores means worse outcome.
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in Depression-Beck Depression Inventory
Description
Depression in Fibromyalgia patients
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in Anxiety-Beck Anxiety Inventory
Description
Anxiety in Fibromyalgia patients
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Secondary Outcome Measure Information:
Title
Change in The Short Form (36) Health Survey
Description
The Short Form (36) Health Survey
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in Fibromyalgia Impact Questionaire
Description
Fibromyalgia Impact Questionaire
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in Revised Fibromyalgia Impact Questionnaire
Description
Revised Fibromyalgia Impact Questionnaire
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale, in this scale minumum value is 0, maximum value is 21, high scores mean worse outcome.
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in The Fatigue Severity Scale
Description
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.
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in Pain beliefs questionnaire
Description
Pain beliefs questionnaire
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
Change in Emotional Expression Questionnaire
Description
Emotional Expression Questionnaire
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Title
CHILDHOOD TRAUMA QUESTIONNAIRE
Description
CHILDHOOD TRAUMA QUESTIONNAIRE
Time Frame
At the beginning of the study
Title
Change in 2016 Fibromyalgia Syndrome Criteria
Description
2016 Fibromyalgia Syndrome Criteria
2016 Fibromyalgia Diagnostic Criteria
Time Frame
At the beginnning of the study ,through study completion-8th week, after study completion -6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simin HEPGULER, Prof
Organizational Affiliation
Ege University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Basak DURDU AKGUN, Dr
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ece Cinar, Assistant Prof
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University Faculty of Medicine
City
Izmır
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21878603
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.
Results Reference
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Citation
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17349056
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.
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PubMed Identifier
16965199
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.
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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.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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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.
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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.
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Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome
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