Effect of EMDR in the Treatment of Fibromyalgia (EMDR)

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?

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: EMDR; Behavioral: TAU

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1-month and 3-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-month and 3-month follow-up.

Collaborators and Investigators

• Sponsor: Academy of Therapeutic Sciences, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Pain; RCT; EMDR
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: ZAT2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No