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
- 1
- 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
研究组 & 干预措施
CBT-MyOWL
A novel talk therapy model where we incorporate the standard CBT model with experiential learning while reading the third novel in the Harry Potter series to teach coping skills and emotional resiliency. The 12 sessions of CBT-MyOWL will follow a modestly adapted version of the intervention offered on www.myowl.org. The therapist will cover topics such as risk and protective factors for distress and mental health problems, cognitive distortions, cognitive reframing, fear hierarchies, behavioural activation and core beliefs while reading Harry Potter and the Prisoner of Azkaban.
干预措施: CBT-MyOWL (Behavioral)
CBT-as-usual
A talk therapy where participants will be encouraged to recognize distortions in thinking and then to reevaluate them in light of the evidence, gain a better understanding of how their behaviour contributes to wellbeing, learn to use problem-solving skills to cope with difficult situations, and learn to develop a greater sense of confidence in one's own abilities. This is the control group, and they will be utilizing the 'Mind over Mood' and/or the 'Anxiety and Phobia Workbook' according to the primary diagnosis.
干预措施: CBT-as-usual (Behavioral)
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