Augmentation of EMDR With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Fibromyalgia: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in severity and in pain intensity as measured by the Visual Analogue Scale (VAS)
研究概览
简要总结
Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is transcranial Direct Current Stimulation (tDCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 96 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to tDCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that tDCS enhances this effect, which will be superior to tDCS-sham.
详细描述
Fibromyalgia (FM) affects 2-4% of the general population with typical symptoms such as generalized and widespread pain, sleep disturbances, problems in memory and attention, anxiety and depression. Pharmacological treatment and psychotherapeutic interventions have produced limited effects so far. Interestingly, lifetime psychosocial adversities are substantially elevated in FM but no interventions are currently offered. Given the complex etiology of FM, combining a psychotherapy with other treatment options can maximize the potential benefit of this intervention. The investigators will test in Barcelona, whether a trauma-oriented therapy, Eye Movement Desensitization Reprocessing (EMDR), in combination with a non-invasive brain stimulation technique, transcranial Direct Current Stimulation (tDCS), can improve typical FM symptoms.
Outcomes
Primary outcomes:
- To test whether EMDR plus tDCS or EMDR plus sham-tDCS in comparison to TAU group, improve pain intensity, depressive and anxious symptoms and trauma associated symptoms after therapy and follow-up.
- To test whether an improvement in pain intensity, depressive and anxious symptoms and trauma associated symptoms can be augmented by simultaneous tDCS comparing EMDR plus tDCS with EMDR plus sham-tDCS after the intervention and whether this is maintained at the follow-up visit.
Secondary outcomes: 3. To test whether the EMDR plus tDCS or EMDR plus sham-tDCS in comparison to TAU group, improves more in subjective wellbeing after the treatment, and whether this is maintained at the follow-up visit.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participant and the care provider will be blind to the tDCS condition as sham-tDCS will be used, whereas the Outcomes assessor will be blind to both conditions.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years old
- •Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks preceding the clinical trial
- •Presence of one or more traumatic events causing current trauma-related symptoms
- •Current clinical symptoms of depression and/or anxiety
- •2 weeks of stable medication
排除标准
- •Comorbid autoimmune or chronic inflammatory disease
- •Neurological or serious medical diseases
- •Bipolar disorder, schizoaffective disorder and schizophrenia
- •Suicidal ideation
- •Previous EMDR therapy in the past two years
- •Substance abuse/dependency within 1 month prior to participation (except for nicotine abuse/dependency),
- •Pending FM-related litigation or disability
- •Metallic implants in the head
- •Positive test for pregnancy
- •Skin sensitivity diseases (psoriasis, eczema, dermatitis, etc.)
结局指标
主要结局
Change in severity and in pain intensity as measured by the Visual Analogue Scale (VAS)
时间窗: Change from baseline to visits at 6 and 12 months
The VAS pain consists of a straight horizontal line anchored between 2 verbal descriptors: "No pain" on the left side and "Unbearable pain" on the right. Scores are interpreted as follows: no pain (0-2), mild pain (2-4), moderate pain (4-6), severe pain (6-8), and maximum pain (8-10). This measure assesses the intensity of the perceived pain over the last 2 weeks.
Change in the impact of fatigue as assessed by the Brief Fatigue Inventory (BFI)
时间窗: Change from baseline to visits at 6 and 12 months
9 item self-report questionnaire used to assess the severity and impact of fatigue on individuals in the past 24h, as well as its interference with various aspects of daily life, such as mood, walking ability, work, relationships, and enjoyment of life. Scores range from 0-10 with 0: "no fatigue"; 1-3: "low"; 4-6: "moderate" y 7-10: "severe"
PTSD diagnosis assessed by the Global Evaluation of Posttraumatic Stress (EGEP-5)
时间窗: Change from baseline to 6 and 12 months
55-item clinician-applied scale to determine current PTSD diagnosis, based on DSM-V criteria. The scale can determine a diagnosis of PTSD, specifying the presence of dissociative symptoms (depersonalization and derealization) and delayed expression.
Change in physical impairment due to FM assessed by The Revised Fibromyalgia Impact Questionnaire (FIQ-R)
时间窗: Change from baseline to visits at 6 and 12 months
9-item self-administered scale for measuring physical impairment due to FM over the last week. Scores range from 0-100 and higher scores indicate greater impact in functioning.
Change in catastrophic thinking related to pain experiences assessed by the Pain Catastrophizing Scale (PCS)
时间窗: Change from baseline to visits at 6 and 12 months
13 item self-report questionnaire designed to assess the extent to which individuals magnify, ruminate, and feel helpless about their pain. Scores range from 0-52 with higher scores indicating greater catastrophizing.
Complex PTSD diagnosis assessed by The International Trauma Questionnaire (ITQ)
时间窗: Measure at baseline
This 12 item questionnaire is a tool used to evaluate and diagnose complex post-traumatic stress disorder (C-PTSD) and other trauma-related disorders, in terms of ICD-11 classification for mental disorders. It assess the presence and severity of PTSD symptoms, as well as disturbances in self-organization associated with C-PTSD.
Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist (PCL-5)
时间窗: Change from baseline to visits at 6 and 12 months
This scale assesses DSM-5 PTSD symptoms using a 20-item questionnaire. Scores range from 0 to 80, with higher scores indicating greater severity. A cut-off score of 33 is used for diagnosis.
Change in subjective perceived distress assessed by Subjective unit of distress (SUD)
时间窗: Change from baseline to visits at 6 and 12 months
this scale, ranging from 0 (no distress) to 10 (maximum distress), evaluates the level of subjective perturbation a person experiences when they bring to mind the traumatic event chosen in the EGEP-5 scale.
Quantifying childhood trauma assessed by The Childhood Trauma Questionnaire (CTQ)
时间窗: Measure at baseline.
Self-applied scale which includes a 28-item test that measure 5 types of childhood maltreatment: emotional, physical and sexual abuse, and emotional or physical neglect. A 5-point Likert scale (from 1 to 5) is used for the responses which range from "never true" to "very often true". The final scores provide a severity score for each subscale from "none to minimal," "low to moderate," "moderate to severe," and "severe to extreme".
Assessing lifetime trauma with the Timeline of traumatic experiences
时间窗: Measure at baseline
The Timeline of traumatic experiences tool was developed specifically for this study and consists of a table that qualitatively compiles different traumatic events that the person may have suffered both in childhood and in adulthood. The table is segmented into 5-year intervals ranging from 0-5 years old to 65-70 years old. Within each segment, participants are asked: "Do you recall experiencing any traumatic or stressful events during this age interval?"
Change in depersonalization symptoms assessed by The Cambridge Depersonalization Scale (CDS)
时间窗: Change from baseline to 6 and 12 months.
A self-report questionnaire designed to assess the severity of depersonalization symptoms. It consists of 29 items that evaluate various aspects of depersonalization, including feelings of detachment from oneself, altered perceptions of time and space, and experiences of unreality. Each item on the CDS is rated on two Likert scales: one for frequency and one for duration. The total score ranges from 0 to 290. A higher total score indicates greater severity of depersonalization symptoms with a cut-off point of 70 to indicate depersonalization symptoms.
Change in somatoform dissociation symptoms assessed by Somatoform Dissociation Questionnaire 20 (SDQ-20)
时间窗: Change from baseline to visits at 6 and 12 months
The SDQ-20 is a 20-item self-report questionnaire measuring somatoform dissociation. Items refer to somatic symptoms and then ask if there is a known cause for them. The items are answered on a 5-point Likert scale and the symptoms with no known cause are summed to achieve the total scorwhich can range from 20 to 100. A higher score indicates a greater degree of somatoform dissociation.
Change in anxious and depressive symptoms assessed by with the Hospital Anxiety and Depression Scale
时间窗: Change from baseline to visits at 6 and 12 months
Severity and changes in anxious and depressive symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.
次要结局
- Change in subjective wellbeing measured with the Satisfaction With Life Scale.(Change from baseline to visits at 6 and 12 months)
- Change in insomnia symptoms assessed with the Athens Insomnia Scale.(Change from baseline to visits at 6 and 12 months)
- Change in subjective wellbeing measured with the Satisfaction With Life Scale.(Change from baseline to visits at 6 and 12 months)
- Change in insomnia symptoms assessed with the Athens Insomnia Scale.(Change from baseline to visits at 6 and 12 months)
- Change in Self-care assessed with The González self-care scale.(Change from baseline to 6 and 12 months.)
- Change in emotion regulation assessed with The Emotion-Regulation Skills Questionnaire (ERSQ).(Change from baseline to 6 and 12 months.)
- Change in self-esteem assessed with The Rosenberg Self-Esteem Scale (RSE).(Change from baseline to 6 and 12 months.)
- Change in cognitive function assessed with The Screen for Cognitive Impairment in Psychiatry (SCIP).(Change from baseline to 6 and 12 months.)
研究者
Alicia Valiente
Principal investigator
Parc de Salut Mar