Effectiveness of Internet-based Acceptance and Commitment Therapy for Cancer Patients: A Pilot Randomized Controlled Trial Using Mixed Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Psychological Distress
研究概览
简要总结
This study will focus on supporting cancer patients who often experience emotional challenges like anxiety and depression. It will test a two-week online program called Acceptance and Commitment Therapy (ACT), designed to help people manage difficult emotions and focus on what matters most in their lives.
The program will include short, easy-to-follow sessions covering helpful strategies like accepting distress and staying present in the moment. Participants will be randomly assigned to either join the ACT program or wait for the program while continuing their usual care. The study aims to determine whether the ACT program can reduce psychological distress, anxiety, and depression in cancer patients. The study will use a mixed-methods approach, combining both quantitative data (such as changes in distress, anxiety, and depression) and qualitative insights from participant interviews. This will help us gain a deeper understanding of how the ACT program may support the psychological distress of cancer patients.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 and above;
- •diagnosed cancer with a clear disease course
- •fluent in Chinese with the ability to read and understand questionnaires independently;
- •ability to operate a smartphone independently;
- •not participating in or intervening in other clinical studies.
排除标准
- •younger than 18 years of age
- •unable to use a smartphone
- •have significant cognitive impairment or a serious systemic disease or psychiatric disorder
- •concurrently participating in other clinical studies or undergoing other psychotherapy
结局指标
主要结局
Psychological Distress
时间窗: Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)
Psychological distress is assessed using the Distress Thermometer (DT) (Holland et al., 2013). Scores range from 0 (no distress) to 10 (extreme distress), with higher scores reflecting greater levels of psychological distress.
Feasibility outcomes
时间窗: Post-intervention (immediately after the 2-week intervention)
Feasibility is evaluated using retention rate and intervention completion rate. Retention rate reflects the percentage of participants who successfully completed all study-related measurements throughout the trial.
Acceptability
时间窗: Post-intervention (immediately after the 2-week intervention)
Acceptability is evaluated using the Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979). This 8-item measure uses a 4-point Likert scale (1 = low satisfaction to 4 = high satisfaction), with higher scores indicating greater satisfaction with the treatment.
Anxiety and Depression
时间窗: Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)
Anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983), a 14-item questionnaire comprising separate subscales for anxiety and depression. Each item is scored on a 4-point Likert scale, and higher scores reflect greater severity of anxiety and depression symptoms.
次要结局
未报告次要终点