Group Dialectical Behaviour Therapy (DBT) Skills Training for Individuals With First Episode Psychosis: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Adherence
研究概览
简要总结
Psychosis is a serious mental health condition that can affect how a person thinks, feels, and functions in daily life, often making it harder to maintain relationships, continue education, or work. Even with standard treatment, many people continue to experience emotional distress, depression, anxiety, and difficulty coping with strong emotions. These challenges can worsen recovery, increase the risk of substance use and suicidal behaviour, and place a significant burden on individuals, families, and the healthcare system.
Dialectical Behaviour Therapy (DBT) is a skills-based psychological treatment that helps people manage emotions, tolerate distress, and improve relationships. Although DBT has been effective in other mental health conditions, it has not been well studied in people with first-episode psychosis.
This study will evaluate an 8-week group DBT skills training adapted for individuals with first-episode psychosis. The study aims to assess whether the program is acceptable and feasible to deliver, and whether it may improve emotion regulation, mood, resilience, and functioning. Findings will inform whether a larger clinical trial of this intervention should be conducted.
详细描述
Despite evidence that individuals with psychotic disorders experience marked emotion dysregulation, impulsivity and elevated suicide risk, they have largely been excluded from clinical trials evaluating DBT. Nevertheless, emerging pilot studies support the feasibility and potential efficacy of brief DBT-informed skills group in individuals with psychosis, with participants reporting high satisfaction and improvements in understanding and managing emotions, suicidality, and interpersonal functioning. However, this literature remains preliminary and underdeveloped, and no studies have evaluated group DBT skills intervention specifically for individuals with first-episode psychosis.
Aim 1: To evaluate the acceptability of the group DBT skills training invention and the feasibility of conducting a fully powered randomized controlled trial (RCT) of in young men with psychosis.
Aim 2: To assess the preliminary efficacy of group DBT skills training in improving emotion regulation, resilience, and functioning and reducing, mood and anxiety and substance use, in a single-arm exploratory clinical trial.
This study will provide evidence of the feasibility, acceptability, and preliminary efficacy of a group DBT skills training for young men with first-episode psychosis. Findings will advance understanding of emotion regulation as a treatment target in psychosis and inform the development of larger controlled trials evaluating emotion-focused interventions in early psychosis care. The intervention could represent a scalable and practical psychosocial treatment to address emotional difficulties that are common but often under-treated in psychosis.
This study employing qualitative and quantitative methods to evaluate the group DBT skills training intervention and test its feasibility, and acceptability in individuals with psychosis. A single arm trial where DBT skills group delivered over 8-weeks, will be conducted. Thirty-two participants are planned to be enrolled in the trial. Participants will continue with their standard outpatient care during the trial. Outcome measures will be completed at study entry and post-treatment. For the qualitative component of the study, 15 post-intervention semi-structured interviews will be conducted.
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
- 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.
- •All gender identities are eligible to participate.
- •Being competent as demonstrated by comprehension of the study procedures, risks, benefits and their rights as a volunteer in the research study and willing to consent to study participation.
- •Meets criteria for a psychotic spectrum disorder as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum disorder, or other unspecified schizophrenia spectrum disorder), or bipolar disorder with psychotic features, and is within 3 years of their initial diagnosis.
排除标准
- •Diagnosis of intellectual disability previously documented in the patient chart.
- •Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
- •Receiving any additional structured psychotherapy interventions during the study period.
研究组 & 干预措施
Group DBT
Receive 8-week Group DBT intervention
干预措施: group DBT (Behavioral)
结局指标
主要结局
Adherence
时间窗: post treatment (8 weeks after baseline)
Percent sessions attended
Retention rates
时间窗: post treatment (8 weeks after baseline)
Percent participants who complete 8-week study.
Attrition
时间窗: post treatment (8 weeks after baseline)
Percent participants that dropout at 8 weeks
Client Satisfaction Questionnaire
时间窗: post treatment (8 weeks after baseline)
A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
Timeline Follow Back (TLFB)
时间窗: From enrollment to the end of treatment at 8 weeks
A self-report method for substance use, and will be used to quantify the amount/frequency of cannabis in the past 14 days.
次要结局
- Brief Psychiatric Rating Scale (BPRS)(From enrollment to the end of treatment at 8 weeks)
- Scale for the Assessment of Negative Symptoms (SANS)(From enrollment to the end of treatment at 8 weeks)
- Calgary Depression Scale for Schizophrenia (CDSS)(From enrollment to the end of treatment at 8 weeks)
- State-Trait Anxiety Inventory (STAI)(From enrollment to the end of treatment at 8 weeks)
- Borderline Symptom List (BSL-23)(From enrollment to the end of treatment at 8 weeks)
- Difficulties in emotion regulation scale (DERS)(From enrollment to the end of treatment at 8 weeks)
- Global Functioning: Social and Role Scales(From enrollment to the end of treatment at 8 weeks)
- Connor-Davidson Resilience Scale (CD-RISC)(From enrollment to the end of treatment at 8 weeks)
- Adolescent Alcohol and Drug Involvement Scale (AADIS)(From enrollment to the end of treatment at 8 weeks)
- Cannabis Use Disorders Identification Test-Revised (CUDIT-R)(From enrollment to the end of treatment at 8 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(From enrollment to the end of treatment at 8 weeks)