Disgust Reduction Through Evaluative Conditioning and tDCS in Patients With Contamination-Based OCD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Disgust Feeling
研究概览
简要总结
Obsessive-compulsive disorder (OCD) is a debilitating health condition that is known by intrusive and unwanted thoughts and repetitive behavioral or mental acts. 2-3% of the population suffers from OCD in their lifetime. The most common OCD subtype is contamination. The Serotonin-selective reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT) based on exposure and response prevention (ERP) technique are the first-line treatments for OCD. The challenge is that nearly half do not respond to the first-line treatments or have residual symptoms after completion of treatments. However, the prevalence of the disorder, diversity of symptoms, inadequate response rate, and necessity of having long-lasting treatment effects make the treatments of OCD more challenging.
It seems that abnormal, more intense disgust experience has a prominent role in developing and maintaining OCD symptoms, particularly the contamination subtype. Evaluative conditioning (EC), defined as transferring the value of the US to the CS through pairing them, is the most common way of establishing disgust responses. The present study aims to develop an emotion-based intervention technique using EC targeting disgust emotion in contamination-based OCD (C-OCD). The hypothesis is that EC training may modify disgust experiences. Disgust may be the culprit, at least in part, of cognitive deficiencies in OCD. The other hypothesis is whether disgust reduction-focused EC may improve cognitive function, such as attention bias and inhibitory control.
The orbitofrontal cortex (OFC) is one of the brain areas engaged in disgust processing and is mostly hyperactive in OCD patients. Cathodal transcranial direct current stimulation (tDCS) over OFC is one of the helpful neuromodulation methods in treating OCD. We aim to see if this method may help to regulate disgust experiences in combination with EC. The participants may be referred by psychiatrists or psychotherapists or be self-referred due to online advertisements or paper flyers. They will be randomly assigned to one of for arms of the study for sham or active EC training along with sham or active tDCS, to which they are blind. The novelty of the present study is the application of EC training in the clinical OCD population in combination with a neuromodulation method.
详细描述
Disgust as a primary emotion has evolved to protect our lives by driving dirt and disease avoidance behaviors and motivating for cleaning and hygienic behaviors. In recent years, many studies have focused on the role of disgust in psychiatric disorders such as anxiety disorders, eating disorders, body dysmorphic disorders, and phobias. Nowadays, we have robust evidence of the correlation between disgust and the etiology and treatment of OCD symptoms, particularly the contamination subtype. The principal explanation for the insufficient treatment effect of ERP is that disgust is resistant to extinction.
Since evaluative conditioning is one of the main sources of disgust feeling, the same process may effectively reduce disgust. The present trial will try to pair contamination-related pictures that are disgust-eliciting with positive, pleasant pictures in order to modify their disgust valence. We also will administer this EC training plus to OFC cathodal tDCS to see if the EC effect becomes more significant than EC alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blind to which of the interventions is active or a sham. Interventional sessions look the same for all participants regarding duration and activities (including doing a computerized EC task and receiving tDCS).
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Diagnostic criteria of OCD in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5-TR) with the symptoms of contamination subtype
- •Able to read, write and do computerized tasks
- •Stable medication for at least the last three months
- •Filling out the written consent
排除标准
- •Severe physical illness
- •Severe other mental disorders
- •Alcohol and drug dependence
- •A history of epilepsy or seizure
- •Have metal or electronic implants in the head or use a cardiac pacemaker
- •History of head trauma or neurological disorders
- •Women who are pregnant or may be pregnant
- •Unable to complete questionnaires, computerized tasks, or informed consent
研究组 & 干预措施
aEC/ stDCS
Participants in this group receive active EC training but sham tDCS.
干预措施: Active EC training (Other)
aEC/ stDCS
Participants in this group receive active EC training but sham tDCS.
干预措施: Sham tDCS (Other)
sEC/atDCS
Participants in this group receive active tDCS training but sham EC training.
干预措施: Sham EC training (Other)
sEC/atDCS
Participants in this group receive active tDCS training but sham EC training.
干预措施: Active tDCS (Other)
aEC/atDCS
Participants in this group receive both active EC training and active tDCS.
干预措施: Active EC training (Other)
aEC/atDCS
Participants in this group receive both active EC training and active tDCS.
干预措施: Active tDCS (Other)
sEC/stDCS
Participants in this group receive the sham EC training and also sham tDCS.
干预措施: Sham EC training (Other)
sEC/stDCS
Participants in this group receive the sham EC training and also sham tDCS.
干预措施: Sham tDCS (Other)
结局指标
主要结局
Disgust Feeling
时间窗: From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)
Effect of evaluative conditioning, cathodal tDCS over OFC, and both on changing disgust feeling intensity measured by disgust rating scale. The scale rates from 0 (not disgusting) to 10 (very disgusting). Lower scores show less disgust feeling.
Clinical Symptoms Severity of Contamination-Based OCD
时间窗: From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment)
Change in Clinical symptoms of contamination-based OCD after evaluative conditioning, cathodal tDCS over OFC, and both, measured by Yale-Brown Obsessive-Compulsive scale. It is scored on a 5-point rating. The lower scores show less symptom severity.
次要结局
- Inhibitory control(From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment))
- The power spectrum of brain waves based on quantitative electroencephalogram(From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment))
- Attentional bias(From pre- to post-assessment (2 weeks after baseline assessment) and from pre- to follow-up assessment (10 weeks after baseline assessment))
研究者
Ali Moghimi
Professor
Ferdowsi University of Mashhad
