Precision Medicine for OCD - Biobehavioral Tracking of Transcranial Magnetic Stimulation (TMS) With Exposure and Response Prevention (ERP) for Refractory OCD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score
研究概览
简要总结
This study will test how people with OCD respond to a type of noninvasive brain stimulation, repetitive Transcranial Magnetic Stimulation (rTMS), when it is combined with psychotherapy. Participants will either engage in Exposure and Response Prevention (ERP) Therapy or supportive therapy (ST) while receiving rTMS. Biobehavioral data from wearable devices and smartphones will be collected to better predict treatment responses. Participants will also undergo repeat resting state functional Magnetic Resonance Imaging (rsfMRI) in order to assess neural predictors and mechanisms of treatment response.
详细描述
This is a randomized, controlled pilot study to evaluate the feasibility, tolerability, and preliminary effects of combining repetitive transcranial magnetic stimulation (rTMS) with one of two types of therapy for adults with Obsessive-Compulsive Disorder (OCD). All participants will receive rTMS targeted to a specific brain area (the dorsomedial prefrontal cortex/anterior cingulate cortex) five days per week (Monday through Friday) for six weeks, utilizing the FDA-cleared treatment protocol. In addition, participants will receive either Exposure and Response Prevention (ERP), a form of cognitive behavioral therapy, or supportive therapy (ST), delivered virtually twice per week during the rTMS treatment period.
The study lasts a total of 16 weeks. During the first week, participants will complete baseline assessments, including questionnaires about symptoms, functioning, quality of life, and treatment priorities. Participants will undergo a brain scan (rsfMRI) and receive a Fitbit device (Charge 6) to wear throughout the study. Participants will also be guided on how to complete daily self-report check-ins using their smartphone. These check-ins, along with the Fitbit, will collect information about behavior (e.g., sleep, physical activity), physiology (e.g., heart rate), and lived experience (e.g., stress, mood, and symptoms) throughout the study period.
rTMS treatment begins in week 2 and continues for six weeks. ERP or supportive therapy sessions are scheduled twice per week, on the same days as rTMS (Tuesdays and Thursdays), and take place while participants are receiving rTMS in the treatment room. Weekly assessments of OCD symptom severity will be conducted throughout the six-week treatment phase.
After the treatment phase ends in week 8, participants will repeat the brain scan and complete final symptom and functioning assessments. At this time, Fitbit data collection and daily surveys will cease. At week 16 (two months after treatment ends), participants will complete a follow-up assessment to evaluate longer-term outcomes.
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)
盲法说明
Participants will know which treatment group they are in but will be blinded to study hypothesis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Obsessive-Compulsive Disorder (OCD) as determined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria.
- •Live in Southern California and be willing to attend in-person to receive repetitive Transcranial Magnetic Stimulation (rTMS) 5 times per week for 6 weeks.
- •Have completed a prior course of Exposure and Response Prevention (ERP) therapy (at least ten sessions)
- •Currently take or have previously tried Serotonin Reuptake Inhibitor (SRI) medication for OCD
- •Willing to maintain psychotropic medication levels throughout the 16 weeks of the study
排除标准
- •Primary psychiatric diagnosis other than OCD
- •Active substance use disorder
- •Active suicidality
- •Active psychosis
- •History of seizures
- •Severe neurological impairment
- •Pregnant or planning to become pregnant
- •Received a prior rTMS course
研究组 & 干预措施
rTMS+ERP
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
rTMS+ERP
干预措施: Exposure and Response Prevention (ERP) Therapy (Behavioral)
rTMS+ST
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
rTMS+ST
干预措施: Supportive Therapy (ST) (Behavioral)
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score
时间窗: From enrollment to end of study at 16 weeks.
The investigators will use the Yale-Brown Obsessive-Compulsive Scale (YBOCS), the gold standard measure of OCD severity, to assess symptom levels. The YBOCS scale assesses five domains of obsessive and compulsive symptoms, which are each scored on a four-point scale, with 0 being "no symptoms" and 4 being "extreme symptoms". Combined scores range from 0 (no symptoms) to 40 (severe symptoms). A trained clinician, blinded to participant treatment, will administer the YBOCS at study enrollment, weekly during rTMS, at study end, and at 2-month follow-up to determine rate of change of YBOCS score, overall change after treatment, and durability of change at follow-up. Greater decreases in YBOCS scores sustained over time represent a better outcome.
次要结局
- Resting state functional connectivity(From enrollment to the end of treatment at 8 weeks.)
- Study dropout rate(From enrollment to end of study at 16 weeks.)
- Stanford Expectations of Treatment Scale (SETS)(Assessed at study start; 1 session.)
- Self-report priorities in treatment(Assessed at study start; 1 session.)
- Fidelity of Adherence to Therapy(From start of therapy at week 2 to end of therapy at end of week 7.)
- Adverse and serious adverse event rates(From enrollment to end of study at 16 weeks.)
- Resting state functional connectivity(From enrollment to the end of treatment at 8 weeks.)
- Recruitment rate(From screening to enrollment.)
- Study dropout rate(From enrollment to end of study at 16 weeks.)
- Stanford Expectations of Treatment Scale (SETS)(Assessed at study start; 1 session.)
- Self-report priorities in treatment(Assessed at study start; 1 session.)
- Fidelity of Adherence to Therapy(From start of therapy at week 2 to end of therapy at end of week 7.)
研究者
Adam Frank
Assistant Professor of Clinical Psychiatry and the Behavioral Sciences
University of Southern California