Effect of EMDR in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

— EMDR  

Official title:

A Randomized Controlled Trial of Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06265194
• Other study ID #: ZAT2024
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: March 2018

Study information

• Verified date: February 2024
• Source: Academy of Therapeutic Sciences, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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?

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academy of Therapeutic Sciences, Turkey

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.