Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percentage of participants who confirm acceptability of the intervention during interviews
研究概览
简要总结
This project's overall goal is to test the feasibility, acceptability and efficacy of two coach-assisted, computer-based, cognitive- behavioral therapy (C-CBT) interventions in treating depression and anxiety in adolescent and young adult cancer survivors. The two coach-assisted interventions will be compared to the standard C-CBT intervention.
详细描述
This will be a three-arm randomized controlled trial with two treatment arms and one control arm. Participants in the first treatment arm will receive a coach-assisted C-CBT intervention called "Beating the Blues" (BtB). A second treatment arm will receive a coach-assisted, animated C-CBT intervention called "Entertain Me Well" (EMW). Both treatment arms will have 8 weekly sessions that contain core components of CBT. A coach will provide between-session support throughout the 8 sessions. The control arm will use the standard care of BtB without coach assistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer survivor, either receiving active treatment or completed cancer treatment
- •Experiencing depression and anxiety as measured by PHQ-9 or GAD-7
排除标准
- •Severe medical or mental condition (e.g. suicidal ideation)
- •Medical condition that prevents patients from operating a computer or tablet
- •Receiving end-of-life care
结局指标
主要结局
Percentage of participants who confirm acceptability of the intervention during interviews
时间窗: 10 weeks
Participants will be interviewed about their perceptions regarding the delivery format, treatment content, and other treatment related factors. Qualitative interviews will be transcribed by research staff and coded using thematic content analysis and axial coding. Qualitative data will be reviewed iteratively until saturation is reached, that is when no new information seems to emerge during coding. Emergence or non-emergence of acceptability theme will be assessed. Findings will be descriptive and will include the percentage of participants who confirm acceptability.
Rate of C-CBT completion
时间窗: 10 weeks
Percentage of participants in each arm who complete at least 6 out of 8 sessions, as measured by online service usage data.
次要结局
- Change in level of distress from baseline to end of intervention(10 weeks)
- Change in level of involvement and participation in health care from baseline to end of intervention(10 weeks)
- Change in level of depression from baseline to end of intervention(10 weeks)
- Change in level of anxiety from baseline to end of intervention(10 weeks)
- Change in level of self-efficacy from baseline to end of intervention(10 weeks)