Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Recruitment
研究概览
简要总结
This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.
详细描述
This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at Clinical High Risk (CHR) for psychosis. Given the limited availability of evidence-based digital interventions tailored to this group, this trial explores whether a digital DBT approach can address emotion dysregulation, mood symptoms, and functional impairments, which are common in CHR populations and may contribute to distress and progression of disease.
Participants will be randomized to receive either d-DBT or treatment-as-usual (TAU). The intervention is designed to be self-directed, incorporating, interactive exercises, and skill-building modules targeting emotional regulation, distress tolerance, mindfulness, and substance use. Primary outcomes include measuring feasibility, acceptability, and usability. Secondary measures will evaluate preliminary clinical outcomes related to psychiatric symptoms, substance use, and functioning. Results will inform future adaptations, larger trials, and clinical applications.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessments will be conducted by a blinded assessor.
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 14-35 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) within 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
- •Severe developmental disorder
- •Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
- •Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.
研究组 & 干预措施
Experimental
This arm will receive the d-DBT intervention.
干预措施: d-DBT (Behavioral)
Control (Treatment as Usual)
This arm will not receive the intervention. Participants continue with standard outpatient care, including routine healthcare provider appointments and medication management.
结局指标
主要结局
Recruitment
时间窗: 8 weeks
The percentage of participants enrolled in the study, with higher numbers indicating greater recruitment success.
Retention
时间窗: 8 weeks
The percentage of participants who remain enrolled by the end of the study, with higher numbers indicating better retention.
Adherence
时间窗: 8 weeks
Percentage of modules completed; higher percentages indicate greater adherence.
Client Satisfaction Questionnaire
时间窗: 8 weeks
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
System Usability Scale
时间窗: 8 weeks
A 10-item Likert scale scored from 1-5; total scores range from 0-100, with higher scores indicating greater perceived usability.
次要结局
- PRIME-Revised (PRIME-R)(Baseline and 8 weeks)
- Borderline Symptom List (BSL-23)(Baseline and 8 weeks)
- Brief Difficulties in Emotion Regulation Scale (DERS-16)(Baseline and 8 weeks)
- Connor-Davidson Resilience Scale (CD-RISC)(Baseline and 8 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline and 8 weeks)
- MATRICS Consensus Cognitive Battery (MCCB)(Baseline and 8 weeks)
- Timeline Follow Back (TLFB)(Baseline and 8 weeks)
- Cannabis Use Disorders Identification Test-Revised (CUDIT-R)(Baseline and 8 weeks)
- Adolescent Alcohol and Drug Involvement Scale (AADIS)(Baseline and 8 weeks)
- Structured Interview for Psychosis-risk Syndromes (SIPS)(Baseline and 8 weeks)
- State-Trait Anxiety Inventory (STAI)(Baseline and 8 weeks)
- Calgary Depression Scale for Schizophrenia (CDSS)(Baseline and 8 weeks)
- Global Functioning: Social and Role Scales(Baseline and 8 weeks)
- Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)(Baseline and 8 weeks)
研究者
Omair Husain
Clinician Scientist, Psychiatrist, Associate Professor
Centre for Addiction and Mental Health