Fibromyalgia SyndromeNCT04517929
Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome
A study testing Group Psychotherapy in people with Fibromyalgia Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Group Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2020to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmır, 35100
About this study
Official title: Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study
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.
Read the 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.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Group Psychotherapy
- Keywords
- fibromyalgia, group therapy, group psychotherapy, pain, depression, anxiety
- Medical subject headings
- Fibromyalgia, Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PsychotherapyOther
9 week group psychotherapy, given by a psychologist trained in group psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia. |
| intervention group | Experimental | Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy. Receives: Other: Group Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Depression-Beck Depression Inventory
Depression in Fibromyalgia patients
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Anxiety-Beck Anxiety Inventory
Anxiety in Fibromyalgia patients
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Secondary outcomes (9)
Change in The Short Form (36) Health Survey
The Short Form (36) Health Survey
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Fibromyalgia Impact Questionaire
Fibromyalgia Impact Questionaire
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Revised Fibromyalgia Impact Questionnaire
Revised Fibromyalgia Impact Questionnaire
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
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.
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
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.
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Pain beliefs questionnaire
Pain beliefs questionnaire
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Emotional Expression Questionnaire
Emotional Expression Questionnaire
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
CHILDHOOD TRAUMA QUESTIONNAIRE
CHILDHOOD TRAUMA QUESTIONNAIRE
Measured: At the beginning of the study
Change in 2016 Fibromyalgia Syndrome Criteria
2016 Fibromyalgia Syndrome Criteria
2016 Fibromyalgia Diagnostic Criteria
Measured: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start20 Oct 2020
- Primary completion1 Jan 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Burcu Turkoglu, Ege University
- Investigators
- Simin HEPGULER, Prof, Study chair, Ege UniversityBasak DURDU AKGUN, Dr, Principal investigator, Ege UniversityEce Cinar, Assistant Prof, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517929
- Sponsor's protocol ID
- 20-6.1T/49
- Status last verified
- Jan 2023
- First submitted
- 27 Jul 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21878603Jones 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.
PubMed 25323744Bennett 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.
PubMed 17349056Arnold 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.
PubMed 16965199BECK 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.
PubMed 13688369Hisli N. Beck Depresyon Ölçeği'nin bir Türk örnekleminde geçerlik ve güvenirliği. Psikoloji Dergisi 1988; 6:118-122.
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.
PubMed 3204199Ulusoy M, Şahin NH, Erkmen H. Turkish version of the Beck Anxiety Inventory: Psychometric properties. J Cognit Psychother 1996; 12:163- 172
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.
PubMed 1491853Bernstein 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.
PubMed 8037246Bernstein 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.
PubMed 12615092Kuzucu Y. , "Duyguları İfade Etme Ölçeği'nin Uyarlanması: Geçerlik Ve Güvenirlik Çalışmaları" Kastamonu Eğitim Dergisi, Cilt:19 No:3, 2011,779-792.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04517929
- Acronym / sponsor ID
- 20-6.1T/49
- Conditions
- Fibromyalgia Syndrome
- Keywords
- fibromyalgia, group therapy, group psychotherapy, pain, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia. |
| intervention group | Experimental | Other: Group PsychotherapyPatients in this group will receive recommendations regarding lifestyle change, exercise, and nutrition related to fibromyalgia and group psychotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Psychotherapy9 week group psychotherapy, given by a psychologist trained in group psychotherapy. | Other | intervention group |
Primary outcome
Change in Pain-Visual Analog Scale
Time frame: 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
Time frame: 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
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Anxiety in Fibromyalgia patients
9 secondary outcomes
Change in The Short Form (36) Health Survey
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Fibromyalgia Impact Questionaire
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Revised Fibromyalgia Impact Questionnaire
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Hospital Anxiety and Depression Scale
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in The Fatigue Severity Scale
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Pain beliefs questionnaire
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Change in Emotional Expression Questionnaire
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
CHILDHOOD TRAUMA QUESTIONNAIRE
Time frame: At the beginning of the study
Change in 2016 Fibromyalgia Syndrome Criteria
Time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 21878603Clauw 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.
- Background: PubMed 25323744Jones 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.
- Background: PubMed 17349056Bennett 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.
- Background: PubMed 16965199Arnold 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.
- Background: PubMed 13688369BECK 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.
- BackgroundHisli N. Beck Depresyon Ölçeği'nin bir Türk örnekleminde geçerlik ve güvenirliği. Psikoloji Dergisi 1988; 6:118-122.
- Background: PubMed 3204199Beck 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.
- BackgroundUlusoy M, Şahin NH, Erkmen H. Turkish version of the Beck Anxiety Inventory: Psychometric properties. J Cognit Psychother 1996; 12:163- 172
- Background: PubMed 1491853Edwards 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.
- Background: PubMed 8037246Bernstein 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.
- Background: PubMed 12615092Bernstein 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.
- BackgroundKuzucu Y. , "Duyguları İfade Etme Ölçeği'nin Uyarlanması: Geçerlik Ve Güvenirlik Çalışmaları" Kastamonu Eğitim Dergisi, Cilt:19 No:3, 2011,779-792.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simin HEPGULER, Prof study chair
Ege University
Basak DURDU AKGUN, Dr principal investigator
Ege University
Ece Cinar, Assistant Prof principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Psychotherapy in people with Fibromyalgia Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain-Visual Analog Scale (time frame: At the beginnning of the study ,through study completion-8th week, after study completion -6th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517929, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.