Digital Acceptance and Commitment Therapy (Digi-ACT): A Randomized Controlled Trial Pilot Assessing the Efficacy and Feasibility of Software-based Self-managed Intervention Targeting Subclinical Depression and Anxiety in Curative Cancer Patients Within Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Changes in Quality of Life as assessed by the Chinese Functional Assessment of Cancer Therapy (FACT-G) from baseline to immediately after treatment and 3 month follow up
研究概览
简要总结
The goal of this clinical trial is to validate the use of digital Acceptance and Commitment Therapy (Digi-ACT) in Hong Kong curative cancer patients with depressive and anxiety symptoms. The main questions it aims to answer are:
- Can Digi-ACT reduce depressive or anxiety symptoms?
- Can Digi-ACT improved health-related quality of life?
- Is Digi-ACT an acceptable and feasible intervention for users?
- What are the factors that influence the success of Digi-ACT?
- Can the video journals used in Digi-ACT predict depressive symptoms?
Intervention group participants will install the Digi-ACT mobile application and undergo a 3-4 week long intervention. They will have to fill out questionnaires at baseline, immediately after the intervention, and at three month follow up to measure depression and anxiety symptoms, health-related quality of life, acceptability of the intervention, and other process outcomes related to the intervention itself.
Researchers will compare the outcomes with a group of participants that undergo a 3-4 week long period where they navigate a similar mobile platform that gives bi-daily psychoeducational videos that also fill out the same clinical questionnaires at baseline, post-intervention, and at three month follow up.
详细描述
Patients with cancer experience increased rates and severity of depression and anxiety symptoms. This could be due to difficulty dealing with the diagnostic process, treatment side effects, limited social opportunities, physical symptoms, and other cancer-related complications. Acceptance and Commitment Therapy (ACT) has proven to be effective in treating these symptoms for cancer patients. Compared to other evidence based therapies, such as second wave cognitive behavioral therapy (CBT), ACT has shown to have larger effect sizes and success in treating this population. One possible explanation could be due to the theoretical and practical approaches of ACT over traditional CBT. Traditional CBT aims to identify illogical thought patterns that are biased or distorted and try to change them, while ACT makes no attempt at changing these thought patterns and simply teaches the participant to accept and experience these thoughts, emotions, and sensations. For cancer patients, feelings of depression when faced with their own mortality, are unavoidable and could be invalidating if told they are "illogical" or "distorted". Therefore, ACT may have the advantage here in recognizing the severity of the cancer journey and providing an alternative way that does not try to change their experiences.
Furthermore, Hong Kong has a persisting mental health treatment gap due to insufficient mental health practitioners. Oftentimes, only moderate to severe cases of common mental disorders are addressed, thereby leaving milder cases untreated. A possible solution to such under-treatment is digital Health, which requires no additional practitioners and has shown promising results in past studies.
Therefore, we aim to test the efficacy, acceptability, and feasibility of a digitized version (mobile application) of ACT for cancer patients in Hong Kong.
We aim to answer several key questions with the current randomized controlled trial (RCT):
- Can Digi-ACT reduce depressive and anxiety symptoms from baseline to post-treatment and will this reduction be sustained at three month follow up?
- Can Digi-ACT improve health related quality of life from baseline to post-treatment and will this reduction be sustained at three month follow up?
- Is Digi-ACT perceived as an acceptable intervention prior to use? How about after use?
- Can different ACT process measures moderate the relationship between treatment and clinical outcomes?
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 (Participant, Care Provider)
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
- •Aged 18 and above
- •PHQ-9 score of 5 to 14
- •BAI score of 8 to 25
- •Fluent in Cantonese or Mandarin
- •Diagnosed with stage 0 to 3 cancer
- •Received surgery as primary treatment at least four months ago
排除标准
- •Diagnosed with metastatic cancer (stage 4)
- •Language/intellectual difficulties
- •Prior diagnoses of other psychiatric conditions other than unipolar depression or anxiety
结局指标
主要结局
Changes in Quality of Life as assessed by the Chinese Functional Assessment of Cancer Therapy (FACT-G) from baseline to immediately after treatment and 3 month follow up
时间窗: baseline, immediately after treatment, 3 month follow up
The 27 item Chinese FACT-G is a validated, self-report instrument that assesses health related quality of life in the past week. Possible scores range from 0 (poor quality of life) to 108 (strong quality of life).
Changes in Depressive Symptoms severity as assessed by the 9 item Chinese Patient Health Questionnaire (PHQ-) from baseline to immediately after treatment and 3 month follow up
时间窗: baseline, immediately after treatment, 3 month follow up
The Chinese PHQ9 is a validated, self-report instrument that assesses depressive symptoms in the past 2 weeks. Possible scores range from 0 (no signs of depressive symptoms) to 27 (severe depressive symptoms).
Changes in Anxiety Symptoms severity as assessed by the Chinese Beck Anxiety Inventory (BAI) from baseline to immediately after treatment and 3 month follow up
时间窗: baseline, immediately after treatment, 3 month follow up
The 21 item Chinese (BAI) is a validated, self-report instrument that assesses anxiety symptoms in the past 2 weeks. Possible scores range from 0 (no signs of anxiety symptoms) to 63 (severe anxiety symptoms).
次要结局
- Feasibility, measured by proportion of content completed by immediately after treatment(immediately after treatment)
- Acceptability, measured by responses to 4 statements regarding expectations of the intervention at baseline and, immediately after treatment, and 3 month follow up.(baseline, immediately after treatment, 3 month follow up)
研究者
Duncan Lim
Cognitive Scientist
Hollo