A Randomized Controlled Trial of a Preventive Behavioral Intervention for Young Adults With Psychotic Experiences
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Peters Delusions Inventory
研究概览
简要总结
This is a randomized controlled trial testing the efficacy of Resilience Training in college students with elevated transdiagnostic risk for developing a serious mental illness.
详细描述
This is a definitive, randomized controlled trial that will measure the efficacy of Resilience Training, a four-session group-based behavioral intervention conducted in transdiagnostically at-risk young adults who have psychotic experiences. The primary goal is to determine whether Resilience Training is superior to a time-matched active control condition, Life Skills Training, in reducing transdiagnostic symptoms of psychopathology, such as psychotic experiences, and improving long-term psychiatric (preventing the onset of psychiatric diagnoses) and functional (improving academic performance and retention in college) outcomes in this at-risk population. In addition, a proposed model of the mechanisms of action of RT, involving reducing emotion reactivity and changes in hippocampal function and connectivity, will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-30 years old
- •Enrolled as a first or second year student (i.e., freshman or sophomore) in an undergraduate program at the college or university where the intervention takes place
- •Students who endorse some psychotic experiences (Peter's et al. Delusion Inventory (PDI) score > 3)
排除标准
- •Inability to provide informed consent
- •Not proficient in English
- •Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization
- •Current enrollment in psychological or behavioral health treatment.
- •Current use of psychotropic medications (other than stimulants) prescribed by a physician.
- •A diagnosis of a serious, chronic mental illness as determined by the Mini-International Neuropsychiatric Interview (MINI)
研究组 & 干预措施
Resilience Training (RT)
RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization.
干预措施: Resilience Training (RT) (Behavioral)
Life Skills Training (LST)
LST is a 4-week program of weekly 90-minute sessions, in which participants are provided information about helpful life skills, including financial literacy, health, physical and internet safety.
干预措施: Life Skills Training (LST) (Behavioral)
结局指标
主要结局
Peters Delusions Inventory
时间窗: Baseline, 4-weeks, 6 month, 12 months, and 24 months
The Peters Delusions Inventory (PDI) is a brief 21-item survey using non-stigmatizing and non-clinical language that obtains ratings of common delusional experiences (e.g. paranoia, grandiosity, ideas of reference) and perceptual aberrations (e.g. experiences of being controlled; thought insertion, withdrawal, and echoing), i.e., psychotic experiences. The PDI also measures conviction, preoccupation, and distress related to these experiences. This scale is scored from 0-21, with higher scores indicating a greater number of experiences endorsed.
次要结局
- Looming network functional activation during fMRI looming paradigm(Baseline, 4-weeks, and 12 months)
- Arterial Spin Labeling -measured perfusion of the hippocampus and other regions(Baseline, 4-weeks, and 12 months)
- Neuromelanin-sensitive Magnetic Resonance Imaging in the midbrain(Baseline, 4-weeks, and 12 months)
- Structural Connectivity: Diffusion Tensor Imaging(Baseline, 4-weeks, and 12 months)
- Grade Point Average(Baseline, 12 months, and 24 months)
- Registrar Enrollment Status Report(Baseline, 12 months, and 24 months)
- Health Services Utilization(Baseline, 12 months, and 24 months)
- Mini-International Neuropsychiatric Interview - DSM 5(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Beck Depression Inventory(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Spielberger State-Trait Anxiety Inventory(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Columbia-Suicide Severity Rating Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- UCLA Loneliness Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Temporal Experience of Pleasure Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Anticipatory and Consummatory Interpersonal Pleasure Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Time Alone Questionnaire(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Social Discomfort Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Prodromal Questionnaire - Brief(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Phalen et al. Screener(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Launay-Slade Hallucination Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Structured Interview for Psychosis/Scale for the Assessment of Prodromal Symptoms(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Connor-Davidson Resilience Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Five Facet Mindfulness Questionnaire(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Self-Compassion Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Reflective Functioning Questionnaire(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Positive and Negative Affect Schedule(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- General Self-Efficacy Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Emotional Reactivity Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Difficulties in Emotion Regulation Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Perceived Stress Scale(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Emotion Recognition Task(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Emotion Differentiation Task(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Reading the Mind in the Eyes(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Stop Distance Paradigm(Baseline, 4-weeks, 6 month, 12 months, and 24 months)
- Hippocampal-frontal functional connectivity(Baseline, 4-weeks, and 12 months)
- Fear conditioning responses of the hippocampus(Baseline, 4-weeks, and 12 months)
- Network-level functional connectivity(Baseline, 4-weeks, and 12 months)
- Network-level functional activation during fear conditioning(Baseline, 4-weeks, and 12 months)
研究者
Daphne Holt
Associate Professor
Massachusetts General Hospital