A Randomized Controlled Trial of Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 主要终点
- Trauma Symptom Checklist-40 (TSC-40)
研究概览
简要总结
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?
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants do not have the knowledge of group interventions.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: TAU (Behavioral)
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.
干预措施: TAU (Behavioral)
结局指标
主要结局
Trauma Symptom Checklist-40 (TSC-40)
时间窗: 1-month and 3-month follow-up.
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.
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 1-month and 3-month follow-up.
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.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 1-month and 3-month follow-up.
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.
次要结局
- Beck Depression Inventory (BDI)(1-month and 3-month follow-up.)