tDCS for Inhibitory Control Deficits: A Test in OCD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score
研究概览
简要总结
This study is investigating whether combining noninvasive brain stimulation with behavior therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and response prevention (ERP) -- a specific type of behavior therapy -- is a first line treatment for OCD. This study will test whether a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS), can help ERP work better.
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
- Double (Participant, Outcomes Assessor)
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
- •Current primary OCD diagnosis and current Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score of ≥16
- •18-65 years of age
- •Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
- •Right-handed
- •No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry. Psychiatric medications will be limited to the following: serotonin reuptake inhibitors (SRI; including clomipramine), combination antidepressants (including bupropion and serotonin-norepinephrine reuptake inhibitors), buspirone, benzodiazepines, and/or stimulants
- •Naive to tDCS
排除标准
- •Active substance use disorder
- •Lifetime diagnosis of psychotic or bipolar mood disorder
- •Previous minimally adequate trial of ERP (e.g., at least 16 sessions including both therapist and self-directed exposure and response prevention)
- •Therapy outside the study protocol which has evidence for efficacy with OCD during the study intervention period
- •Active suicidal or homicidal ideation
- •Organic brain disease or injury
- •Any health problems that would interfere with study participation, including contraindications to tDCS (e.g., skin condition, mental implant in skull)
- •Women who are pregnant or breastfeeding. All women participants of child-bearing age are required to have a negative pregnancy test prior to treatment, and must use medically acceptable birth control during study participation. Medically acceptable birth control includes: established oral, injected, implanted, or vaginal ring hormonal contraception, an intrauterine device (IUD), two barrier contraception methods (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), or having a vasectomized partner
- •Use of anticonvulsant medications (including depakote, gabapentin, tegretol, dilantin, lamictal) and/or glutamate-acting agents (including n-acetylcysteine, riluzole, amantadine, memantine).
研究组 & 干预措施
ERP plus tDCS
ERP plus anodal tDCS of right inferior frontal gyrus
干预措施: ERP plus tDCS (Other)
ERP plus sham tDCS
ERP plus sham tDCS of right inferior frontal gyrus
干预措施: ERP plus sham tDCS (Other)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score
时间窗: Post-treatment (approximately 6.5 weeks post-baseline)
The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.
Client Satisfaction Questionnaire-8: Total Score
时间窗: Post-treatment (approximately 6.5 weeks post-baseline)
The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.
Rates of Session Completion
时间窗: Approximately 6.5 weeks post-baseline
Average number of intervention sessions completed
次要结局
- Yale-Brown Obsessive-Compulsive Scale: Total Score(1-month follow up (Approximately 11 weeks after baseline assessment))
- Client Satisfaction Questionnaire-8: Total Score(1-month follow up (Approximately 11 weeks after baseline assessment))
- Rates of Retention in Intervention(Approximately 6.5 weeks post-baseline)