Effect of EMDR in the Treatment of Fibromyalgia

NCT ID: NCT06265194

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2018-03-31

Brief 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.

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).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention (TAU and EMDR)

Intervention Group: Received TAU and EMDR Therapists delivering EMDR Therapy provided psychotherapeutic services to clients in the experimental group using the EMDR Fibromyalgia Treatment.

Group Type: EXPERIMENTAL

EMDR

Intervention Type: BEHAVIORAL

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.

TAU

Intervention Type: BEHAVIORAL

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.

Control (TAU)

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.

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: BEHAVIORAL

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.

Interventions

EMDR

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.

Intervention Type: BEHAVIORAL

TAU

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of fibromyalgia,

2. Age between 18-65,

3. Compliance with routine medical fibromyalgia treatment,

4. Cognitive and technical competence to meet the working conditions,

5. Volunteering to participate in the study.

Exclusion Criteria

1. Receiving any psychotherapy,

2. 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.),

d) Presence of an organic cause that can cause pain.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academy of Therapeutic Sciences, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 38835548 (View on PubMed)

Other Identifiers

ZAT2024

Identifier Type: -

Identifier Source: org_study_id