Harnessing Hormonal Variation to Probe Neural Mechanisms and Optimize CBT Outcomes for OCD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- fMRI
研究概览
简要总结
Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.
详细描述
This study involves neuroimaging and a brief EX/RP protocol. The investigators will recruit both male and female participants. All participants will complete neuroimaging, hormonal assays and symptom ratings before and after a brief course of EX/RP. Female participants will be randomized to complete brief EX/RP during distinct phases of their menstrual cycles. This design will allow the investigators to study the effects of hormonal variation during the menstrual cycle and sex on the fear extinction network and on EX/RP outcome. The long-term goal is to optimize EX/RP for individuals suffering from OCD. Men will also be recruited for this study to further explore biological sex differences. The results will elucidate treatment mechanisms and could lead to personalized treatment recommendations for women with OCD.
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
Study hypotheses will be masked to participant, therapist, and outcome assessor. Assignment of women participants to groups will be masked to therapist, investigator, and outcome assessor.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD;
- •Male and female subjects aged between 18- 45;
- •Women must be menstruating and regularly cycling
- •Ability to tolerate a treatment-free period;
- •No psychotropic medication in the past 12 weeks
- •At entry, at least moderate severity OCD
- •Willingness and ability to give written informed consent after full explanation of study procedures.
排除标准
- •Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause.
- •Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study.
- •Neurologic or medical condition that would prevent safe participation in the full study protocol.
- •Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices).
- •Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results.
- •Patients with prominent suicidal ideation or with a recent suicide attempt.
- •Current psychotherapy
研究组 & 干预措施
Experimental 2
Half of female participants will be randomized to receive a brief EX/RP protocol in days 12-22 of the menstrual cycle (late follicular, early luteal phase).
干预措施: Exposure & Response Prevention (EX/RP) (Behavioral)
Active Comparator
Male participants will receive a brief EX/RP protocol within a 10-day window.
干预措施: Exposure & Response Prevention (EX/RP) (Behavioral)
Experimental 1
Half of female participants will be randomized to receive a brief EX/RP protocol within the first 10 days after the start of menstruation (early follicular phase).
干预措施: Exposure & Response Prevention (EX/RP) (Behavioral)
结局指标
主要结局
fMRI
时间窗: Baseline to approximately 4 weeks later
Slope of change in brain activation (fMRI)
OCD Symptoms
时间窗: Baseline to approximately 4 weeks later
Slope of change in Obsessive Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
次要结局
- rs fMRI(Baseline to approximately 4 weeks later)