FibromyalgiaEMDRNCT06265194
Effect of EMDR in the Treatment of Fibromyalgia
A study testing EMDR and TAU in people with Fibromyalgia, run by Academy of Therapeutic Sciences, Turkey.
Trial summary
The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- EMDR and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to Mar 2018
- 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
- Diagnosis of fibromyalgia,
- Age between 18-65,
- Compliance with routine medical fibromyalgia treatment,
- Cognitive and technical competence to meet the working conditions,
- Volunteering to participate in the study.
Who cannot join
- Receiving any psychotherapy,
- Presence of psychiatric disorders such as Schizophrenia or Bipolar Affective Disorder, c) No other physical and psychological targets apart from trauma needing to be addressed before fibromyalgia pain (e.g., suicide, domestic violence, etc.),
- Presence of an organic cause that can cause pain.
About this study
Official title: A Randomized Controlled Trial of Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Fibromyalgia
The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.
The main questions it aims to answer are:
- Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?
- Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?
- Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia?
Read the detailed description
Background: In addition to pharmacological treatments, psychotherapeutic approaches are recommended for the treatment of fibromyalgia. There is a suggestion that Eye Movement Desensitization and Reprocessing (EMDR) therapy may be effective. This study aims to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients through a Randomized Controlled Study (RCT).
Material and methods: The sample for this study comprises 79 individuals diagnosed with fibromyalgia. Participants were randomly assigned to two groups: the 'Treatment as Usual' (TAU) group and the TAU+EMDR group. Prior to the study and at six different time points (before starting the study, at the end of the 5th, 10th, and 15th sessions, 1 month later, and 3 months later), participants completed assessments, including the Fibromyalgia Impact Questionnaire (FIQ), Visual Analog Scale (VAS), Fibromyalgia ACR 2010 Diagnostic Criteria (Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Trauma Symptom Checklist-40 (TSC-40).
- Conditions
- Fibromyalgia
- Being tested
- EMDR, TAU
- Keywords
- EMDR, RCT, Depression, Pain
- Medical subject headings
- Fibromyalgia, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
The fibromyalgia protocol applied to the patients in the study was developed specifically for fibromyalgia by Konuk, and colleagues (Konuk et al.). In addition to the article, the details of the protocol and the study sheet are presented supplementary. After a short introduction, the participants were informed about the protocol, their -consent was obtained for registration, and a visual, tactile and audio bilateral stimulus that will be used in the application was introduced.
TAUBehavioural
Treatment as Usual (TAU): Routine fibromyalgia treatments, referred to as Treatment as Usual (TAU) in this study, were initiated in the outpatient clinic conditions. TAU are treatments designed by rheumatologists in accordance with current rheumatology guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (TAU and EMDR) | Experimental | Intervention Group: Received TAU and EMDR Therapists delivering EMDR Therapy provided psychotherapeutic services to clients in the experimental group using the EMDR Fibromyalgia Treatment. Receives: Behavioral: EMDR; Behavioral: TAU |
| Control (TAU) | Active comparator | Control Group: TAU Routine fibromyalgia treatments, referred to as Treatment as Usual (TAU) in this study, were initiated in the outpatient clinic conditions. TAU are treatments designed by rheumatologists in accordance with current rheumatology guidelines. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
Patients with fibromyalgia pain who underwent the EMDR fibromyalgia protocol will exhibit greater improvement compared to the control group. The scores are between 0-4, and more scores mean worse results for the relevant items.
Measured: 1-month and 3-month follow-up.
Pittsburgh Sleep Quality Index (PSQI)
The experimental group will show a significant reduction in sleep difficulties, and this improvement will persist in one-month and three-month follow-ups. The scores are between 0-3, and more scores mean worse results for the relevant items.
Measured: 1-month and 3-month follow-up.
Trauma Symptom Checklist-40 (TSC-40)
Traumatic stress symptoms in fibromyalgia patients from the experimental group will significantly decrease after undergoing the EMDR Fibromyalgia Protocol. The scores are between 0-3, and more scores mean worse results for the relevant items.
Measured: 1-month and 3-month follow-up.
Secondary outcomes (1)
Beck Depression Inventory (BDI)
The EMDR Fibromyalgia Protocol used in the study is not designed for depression primarily, however, even in this case, the level of depression will be decreased in the experimental group. The scores are between 0-3, and more scores mean worse results for the relevant items.
Measured: 1-month and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2015
- Primary completion1 Jan 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Model description
- Eligible participants were randomized into two groups: one receiving TAU treatment (control group) and the other receiving both TAU and EMDR (experimental group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy of Therapeutic Sciences, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265194
- Sponsor's protocol ID
- ZAT2024
- Acronym
- EMDR
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zat Ciftci Z, Delibas DH, Kaya T, Kulcu DG, Sari A, Nazlikul H, Coskun Topsakal I, Aydin YE, Kavakci O, Savran C, Konuk E. A randomized controlled trial of Eye Movement Desensitization and Reprocessing (EMDR) Therapy in the treatment of fibromyalgia. Front Psychiatry. 2024 May 21;15:1286118. doi: 10.3389/fpsyt.2024.1286118. eCollection 2024.
PubMed 38835548
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT06265194
- Acronym / sponsor ID
- EMDR / ZAT2024
- Conditions
- Fibromyalgia
- Keywords
- EMDR, RCT, Depression, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Academy of Therapeutic Sciences, TurkeyUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Feb 2024 (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 goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.
The main questions it aims to answer are:
- Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?
- Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?
- Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia?
Detailed description
Background: In addition to pharmacological treatments, psychotherapeutic approaches are recommended for the treatment of fibromyalgia. There is a suggestion that Eye Movement Desensitization and Reprocessing (EMDR) therapy may be effective. This study aims to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients through a Randomized Controlled Study (RCT).
Material and methods: The sample for this study comprises 79 individuals diagnosed with fibromyalgia. Participants were randomly assigned to two groups: the 'Treatment as Usual' (TAU) group and the TAU+EMDR group. Prior to the study and at six different time points (before starting the study, at the end of the 5th, 10th, and 15th sessions, 1 month later, and 3 months later), participants completed assessments, including the Fibromyalgia Impact Questionnaire (FIQ), Visual Analog Scale (VAS), Fibromyalgia ACR 2010 Diagnostic Criteria (Widespread Pain Index (WPI) and Symptom Severity Scale (SSS)), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Trauma Symptom Checklist-40 (TSC-40).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible participants were randomized into two groups: one receiving TAU treatment (control group) and the other receiving both TAU and EMDR (experimental group).
| Arm | Type | Receives |
|---|---|---|
| Intervention (TAU and EMDR) | Experimental | Behavioral: EMDR, Behavioral: TAUIntervention Group: Received TAU and EMDR Therapists delivering EMDR Therapy provided psychotherapeutic services to clients in the experimental group using the EMDR Fibromyalgia Treatment. |
| Control (TAU) | Active comparator | Behavioral: TAUControl Group: TAU Routine fibromyalgia treatments, referred to as Treatment as Usual (TAU) in this study, were initiated in the outpatient clinic conditions. TAU are treatments designed by rheumatologists in accordance with current rheumatology guidelines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of fibromyalgia,
- Age between 18-65,
- Compliance with routine medical fibromyalgia treatment,
- Cognitive and technical competence to meet the working conditions,
- Volunteering to participate in the study.
Key exclusion criteria (3 listed)
- Receiving any psychotherapy,
- Presence of psychiatric disorders such as Schizophrenia or Bipolar Affective Disorder, c) No other physical and psychological targets apart from trauma needing to be addressed before fibromyalgia pain (e.g., suicide, domestic violence, etc.),
- Presence of an organic cause that can cause pain.
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 |
|---|---|---|
| EMDRThe fibromyalgia protocol applied to the patients in the study was developed specifically for fibromyalgia by Konuk, and colleagues (Konuk et al.). In addition to the article, the details of the protocol and the study sheet are presented supplementary. After a short introduction, the participants were informed about the protocol, their -consent was obtained for registration, and a visual, tactile and audio bilateral stimulus that will be used in the application was introduced. | Behavioural | Intervention (TAU and EMDR) |
| TAUTreatment as Usual (TAU): Routine fibromyalgia treatments, referred to as Treatment as Usual (TAU) in this study, were initiated in the outpatient clinic conditions. TAU are treatments designed by rheumatologists in accordance with current rheumatology guidelines. | Behavioural | Control (TAU), Intervention (TAU and EMDR) |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 1-month and 3-month follow-up.
Patients with fibromyalgia pain who underwent the EMDR fibromyalgia protocol will exhibit greater improvement compared to the control group. The scores are between 0-4, and more scores mean worse results for the relevant items.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1-month and 3-month follow-up.
The experimental group will show a significant reduction in sleep difficulties, and this improvement will persist in one-month and three-month follow-ups. The scores are between 0-3, and more scores mean worse results for the relevant items.
Trauma Symptom Checklist-40 (TSC-40)
Time frame: 1-month and 3-month follow-up.
Traumatic stress symptoms in fibromyalgia patients from the experimental group will significantly decrease after undergoing the EMDR Fibromyalgia Protocol. The scores are between 0-3, and more scores mean worse results for the relevant items.
1 secondary outcome
Beck Depression Inventory (BDI)
Time frame: 1-month and 3-month follow-up.
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 20 Feb 2024.
- Derived from this study: PubMed 38835548Zat Ciftci Z, Delibas DH, Kaya T, Kulcu DG, Sari A, Nazlikul H, Coskun Topsakal I, Aydin YE, Kavakci O, Savran C, Konuk E. A randomized controlled trial of Eye Movement Desensitization and Reprocessing (EMDR) Therapy in the treatment of fibromyalgia. Front Psychiatry. 2024 May 21;15:1286118. doi: 10.3389/fpsyt.2024.1286118. eCollection 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR and TAU in people with Fibromyalgia, run by Academy of Therapeutic Sciences, Turkey.
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 3 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: 1-month and 3-month follow-up.). 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 NCT06265194, which also lists 1 linked publication.
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 20 Feb 2024.