Effect of EMDR in the Treatment of Fibromyalgia

NCT06265194 | Completed

• 1 other identifier: ZAT2024
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Fibromyalgia

Keywords

EMDR; RCT; Depression; Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Beck Depression Inventory (BDI)

  1-month and 3-month follow-up.

Study Arms (2)

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.

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.

Behavioral: TAU

Interventions

EMDR 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.

Intervention (TAU and EMDR)

TAU 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); Intervention (TAU and EMDR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Academy of Therapeutic Sciences, Turkey: lead

Related Publications (1)

• 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.

  PMID: 38835548 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Depression; Pain

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not have the knowledge of group interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants were randomized into two groups: one receiving TAU treatment (control group) and the other receiving both TAU and EMDR (experimental group).

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 20, 2024

Record last verified: 2024-02