Neurofeedback With Magnetic Resonance Imaging (MRI) for OCD Participants With Treatment-resistance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean change from baseline in the score of Perceived Stress Scale with 10 items.
研究概览
简要总结
The aim of this study is to teach participants with a OCD diagnosis and treatment-resistance how to decrease the response from a brain region involved in the disease by using a technique called neurofeedback. While using this technique, the participants visualize their own brain response in a screen during a MRI exam. Participants will learn strategies to decrease brain responses. The neurofeedback technique is non-invasive, without known risks to participants. With this study, it is expect that the neurofeedback training over 2 weeks (2 sessions) will reduce the OCD symptoms when compared to a control intervention based on neurofeedback's placebo effects.
详细描述
OCD individuals will be recruited at Hospital of Braga, Braga, Portugal, in collaboration with the Psychiatry Unit (n = 30, nonrandom convenience sample based on effect size of 0.30, alpha = beta = 0.05, and ANOVA repeated measures within-between interaction). Some participants may quit the study but sample size was predetermined considering a putative 30 percent dropout rate. Clinical history will be assessed (sociodemographic information, disease onset and severity, and previous/current treatments). The participants' neuropsychological state, the blood hormonal levels, and brain function and structure as baseline measures before and after the neurofeedback intervention will be assessed. Two MRI neurofeedback sessions will be performed during 2 weeks (2 distinct days; 36 min per session) in a 3 T MRI scanner. Data analysis will be performed with a repeated measures design (baseline and after neurofeedback) between the groups to measure brain, blood, and neuropsychological changes. Patients will be supervised by a physician to track putative complications/adverse effects during the intervention. The participation will be immediately interrupted in case of adverse reactions or symptomatic worsening and a physician will follow the participants to provide the appropriated care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
OCD participants will be blindly split into the two groups before the neurofeedback intervention. The psychologist evaluating the psychometric outcomes will be blind to the type of intervention of each participant.
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
- •Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders;
- •Treatment resistance (≥ 3 selective serotonin reuptake inhibitors in proper dose for ≥ 12 weeks).
排除标准
- •Concomitant psychiatric or neurological illness;
- •Substance abuse/dependence in the past 6 months (except nicotine/caffeine);
- •Acute suicidal ideation;
- •Psychotropic medication (except selective serotonin reuptake inhibitors, anafranil, or low-dose hypnotic or anxiolytic taken occasionally);
- •MRI contraindications (pregnancy, major head trauma, severe claustrophobia, severe back pain, ferromagnetic materials/prostheses/implants inside the body, or other).
结局指标
主要结局
Mean change from baseline in the score of Perceived Stress Scale with 10 items.
时间窗: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Psychometric scale to evaluate perceived stress symptoms. The total score ranges from 0 to 40. Lower total scores represent a better outcome.
Mean change from baseline in Emotion Regulation Questionnaire score.
时间窗: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Psychometric scale to evaluate cognitive regulation and emotional suppression capabilities. The cognitive regulation subscale score ranges from 6 to 42 and the emotional suppression subscale score ranges from 4 to 28. Lower emotional suppression scores and higher cognitive regulation scores represent a better outcome.
Mean change from baseline in Hamilton Anxiety Rating Scale score.
时间窗: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Psychometric scale to evaluate anxiety symptoms. The total score ranges from 0 to 56 with the following classification: 0-16 mild anxiety symptoms, 17-24 mild to moderate anxiety symptoms, 25-30 moderate to severe anxiety symptoms, and \>= 31 severe anxiety symptoms. Lower total scores represent a better outcome.
Mean change from baseline in Yale-Brown Obsessive Compulsive Scale score.
时间窗: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Psychometric scale to evaluate obsessive-compulsive symptoms. The total score ranges from 0 to 50 with the following classification: 0-7 sub-clinical symptoms, 8-15 moderate symptoms, 16-31 severe symptoms, and \>= 32 extreme symptoms. This scale can be divided into two subscales: compulsions subscale (score ranging from 0 to 25) and obsessions subscale (score ranging from 0 to 25). The sum of the subscales scores gives the total score of the scale. Lower total and subscale scores represent a better outcome.
Mean change from baseline in Hamilton Depression Rating Scale score.
时间窗: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Psychometric scale to evaluate depression symptoms. The total score ranges from 0 to 52 with the following classification: 0-7 no symptoms, 8-16 mild depression symptoms, 17-23 moderate depression symptoms, and \>= 24 severe depression symptoms. Lower total scores represent a better outcome.
Mean change from baseline in Obsessive-Compulsive Inventory-Revised score.
时间窗: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Psychometric scale to evaluate obsessive-compulsive symptoms. The total score ranges from 0 to 72. This scale can be divided into six subscales: checking subscale (score ranging from 0 to 12), hoarding subscale (score ranging from 0 to 12), neutralizing subscale (score ranging from 0 to 12), obsessing subscale (score ranging from 0 to 12), ordering subscale (score ranging from 0 to 12), and washing subscale (score ranging from 0 to 12). The sum of the subscales scores gives the total score of the scale. Lower total and subscale scores represent a better outcome.
Mean change from baseline in State-Trait Anxiety Inventory score.
时间窗: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Psychometric scale to evaluate anxiety symptoms. The total score ranges from 40 to 160 with the following classification: 40-76 sub-clinical symptoms, \>= 78 clinical symptoms. This scale can be divided into two subscales: state anxiety subscale (score ranging from 20 to 80) and trait anxiety subscale (score ranging from 20 to 80). The sum of the subscales scores gives the total score of the scale. Lower total and subscale scores represent a better outcome.
次要结局
- Differences from baseline in brain grey and white matter structure.(2-3 days before the intervention, 2-3 days after the intervention)
- Difference from baseline in functional connectivity patterns in the brain.(2-3 days before the intervention, 2-3 days after the intervention)
- Mean change from baseline in blood hormonal composition(2-3 days before the intervention, 2-3 days after the intervention)
研究者
Pedro Morgado
Assistant Professor, M.D., Ph.D.
University of Minho