Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
This proposal aims to adapt an evidence-based comprehensive psychosocial and mental health support program, the Optimal Health Program (OHP), to improve functioning, reduce distress, and build resiliency in youth who are at clinical risk of developing psychosis (CHR).
The main aims of the studies are 1). To adapt an existing, effective, validated psychological intervention for use in young people with CHR; 2). To evaluate the acceptability of OHP and the feasibility of conducting a clinical trial of OHP in individuals with CHR; 3). To assess the preliminary efficacy of OHP in enhancing resiliency, reducing depression and anxiety, and improving functioning in individuals with CHR in a single-arm exploratory clinical trial.
Participants will be delivered OHP intervention over 12-weeks. Measures will be completed at study entry and repeated immediately post-treatment at 12-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 16-29 years old
- •Being competent and willing to consent to study participation
- •Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) either currently or at some point in the past 3 years.
排除标准
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
- •Diagnosis of intellectual disability previously documented in the patient chart
- •Severe developmental disorder
- •Acute suicidality requiring immediate intervention
研究组 & 干预措施
treatment arm
The single treatment arm will be administered optimal health program (OHP) intervention.
干预措施: Optimal Health Program (Behavioral)
结局指标
主要结局
Adherence
时间窗: post treatment (12 weeks after baseline)
Percent sessions attended.
Retention rates
时间窗: post treatment (12 weeks after baseline)
Percent participants who complete 12-week sessions.
Attrition
时间窗: post treatment (12 weeks after baseline)
Percent participants that dropout at 12-weeks
Client Satisfaction Questionnaire
时间窗: post treatment (12 weeks after baseline)
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
次要结局
- Structured Interview for Prodromal Symptoms(baseline and post treatment (12 weeks after baseline))
- State and trait anxiety inventory(baseline and post treatment (12 weeks after baseline))
- Global Functioning: Social(baseline and post treatment (12 weeks after baseline))
- Psychiatric diagnoses(baseline and post treatment (12 weeks after baseline))
- Connor-Davidson Resilience Scale(baseline and post treatment (12 weeks after baseline))
- Calgary Depression Scale for Schizophrenia(baseline and post treatment (12 weeks after baseline))
- Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)(baseline and post treatment (12 weeks after baseline))
- Global Functioning: Role(baseline and post treatment (12 weeks after baseline))