Clinical trial NCT06265194: Effect of EMDR in the Treatment of Fibromyalgia
Official title: A Randomized Controlled Trial of Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: EMDR
RCT
Depression
Pain
Lead sponsor: Academy of Therapeutic Sciences, Turkey
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 1-month and 3-month follow-up.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1-month and 3-month follow-up.
measure: Trauma Symptom Checklist-40 (TSC-40)
timeFrame: 1-month and 3-month follow-up.
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 1-month and 3-month follow-up.
Other outcomes:
Locations:
Study officials:
References: