I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Dropout rates
研究概览
简要总结
The goal of this clinical trial is to learn if CBT(Cognitive Behavioural Therapy)-MyOWL(Optimizing Wellness through Literature) is feasible, leads to better patient retention, and has high acceptability by youth psychiatric outpatients with mood and/or anxiety disorder aged 14-19. The main questions it aims to answer are:
Primary Objective (feasibility): To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.
Primary Objective (acceptability): To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants.
Secondary Objectives:
- To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.
- To determine whether youth who receive CBT-MyOWL have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive CBT-as usual: i) depression and anxiety ii) suicidal ideation, iii) self-harm, and iv) coping and emotional resiliency.
Participants will:
Participate in 12 sessions of either CBT-MyOWL or CBT-as-usual (active control) Completes 4-5 questionnaires at sessions 3,6,9,12 Complete the acceptability and exit interview at session 12
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
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 14-19
- •Primary diagnosis of a mood disorder or an anxiety disorder
- •Ability to understand written and spoken English and to read a novel
- •Treating physician considers CBT as indicated for the patient
排除标准
- •Patients already participating in active CBT therapy or recently completed CBT treatment (within the past 3 months)
- •Active psychosis or mania
结局指标
主要结局
Dropout rates
时间窗: Comparing the baseline and across the 12 weeks
To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.
Acceptability Questionnaire
时间窗: 12 week session
To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants.\* \*Note, given that CBT-as-usual is the gold standard treatment, we assume it will be feasible and acceptable and are mainly interested in the feasibility and acceptability of CBT-MyOWL. However, we believe it is important to measure both and will report on any differences identified.
次要结局
- Change from Baseline in The Cognitive and Behavioural Response to Stress Scale score to weeks 3, 6, 9 and 12(Baseline, Week 3, Week 6, Week 9 and Week 12)
- Change from Baseline in Revised Children's Anxiety and Depression Scale score to weeks 3, 6, 9 and 12(Baseline, Week 3, Week 6, Week 9 and Week 12)
- Changes from Baseline in The Columbia-Suicide Severity Rating Scale score to weeks 3, 6, 9 and 12(Baseline, Week 3, Week 6, Week 9 and Week 12)
- Retention(Comparing the baseline and across the 12 weeks)
- Change from Baseline in The Coping Scale for Children and Youth score to weeks 3, 6, 9 and 12(Baseline, Week 3, Week 6, Week 9 and Week 12)
研究者
Mark Sinyor
Staff Psychiatrist
Sunnybrook Health Sciences Centre