The Validation of ICBT Clinical Trial: Disease Stress Adjustment in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Psychological Distress as Assessed by the Depression, Anxiety and Stress Scale-21
研究概览
简要总结
Breast cancer and its treatment can cause ongoing emotional distress, including anxiety, depressive symptoms, stress-related reactions, and difficulties adjusting to life after treatment. This study evaluates an 8-week Internet-based cognitive behavioral therapy (ICBT) program designed to support psychological adjustment and improve quality of life among adults with stage I-III breast cancer who have completed primary cancer treatment.
Approximately 100 participants will be randomly assigned to either an ICBT group or a control group. Participants in the ICBT group will receive treatment as usual together with the 8-week online program, while participants in the control group will receive treatment as usual alone during the main study period. The study will compare changes in anxiety, depressive symptoms, post-traumatic stress symptoms, and quality of life between the two groups.
详细描述
Breast cancer survivors may continue to experience psychological distress after completing primary cancer treatment. Barriers such as limited access to psychological services, time constraints, and concerns about stigma may prevent patients from receiving timely mental health support. Internet-based cognitive behavioral therapy may provide a flexible and accessible approach to supporting psychological adjustment among this population.
This randomized, parallel-group study aims to evaluate the effectiveness of an 8-week culturally adapted Internet-based cognitive behavioral therapy program for adults with stage I-III breast cancer who have completed primary treatment. The program, titled "Healthy Steps: Women's Mental Well-Being," integrates cognitive behavioral therapy principles, psycho-oncology experience, and digital intervention technology.
Approximately 100 participants will be randomly assigned to one of two groups. Participants in the intervention group will continue to receive treatment as usual and will additionally complete the 8-week ICBT program through a mobile application developed by the National Health Research Institutes. The program includes content and exercises related to self-compassion, cognitive restructuring, emotional regulation, and stress management. The study system will be used to record learning progress, questionnaire completion, and program use.
Participants in the control group will receive treatment as usual without additional ICBT during the main comparative study period. After completing the study assessments, control-group participants may request access to the ICBT program.
Assessments will be conducted at baseline, week 5, week 9, and 3 months after completion of the intervention period. The primary analyses will compare changes in anxiety symptoms, depressive symptoms, post-traumatic stress symptoms, and quality of life between the intervention and control groups. Exploratory analyses will examine the relationships between attachment orientation and changes in psychological outcomes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years.
- •Diagnosis of stage I-III breast cancer.
- •Completion of primary breast cancer treatment, including surgery, chemotherapy, radiation therapy, and/or targeted therapy. Participants currently receiving endocrine therapy are eligible.
- •Ability to read and write Chinese and to use a mobile application and the Internet.
- •Access to an Internet-enabled device and ability to independently participate in the online intervention.
- •Willingness to complete the online intervention modules and study assessment questionnaires.
排除标准
- •Diagnosis of stage IV breast cancer.
- •Concurrent diagnosis of another type of cancer.
- •Currently receiving surgery, chemotherapy, radiation therapy, or targeted therapy for breast cancer.
- •Diagnosis of a psychiatric disorder within the past 6 months, including major depressive disorder, generalized anxiety disorder, or schizophrenia.
- •No current psychiatric diagnosis but a Patient Health Questionnaire-9 (PHQ-9) score greater than 20 at screening.
- •Current suicidal intent or a history of actual self-harm behavior.
- •Currently receiving another form of psychotherapy or having recently received cognitive behavioral therapy.
- •Inability to independently use the online intervention application because of insufficient Chinese literacy, Internet proficiency, or access to an Internet-enabled device.
研究组 & 干预措施
Treatment as Usual Control
Participants assigned to this arm will receive treatment as usual (TAU), consisting of routine clinical care provided by their treating health care professionals. They will not receive the Internet-based cognitive behavioral therapy program during the main comparative study period and will complete assessments according to the same schedule as the intervention group. After completing all study assessments, participants may request access to the ICBT program.
干预措施: Treatment as Usual (TAU) (Other)
ICBT Plus Treatment as Usual
Participants will continue to receive treatment as usual and will additionally complete the 8-week "Healthy Steps: Women's Mental Well-Being" Internet-based cognitive behavioral therapy program through a mobile application. The program includes psychoeducational content and exercises related to self-compassion, cognitive restructuring, emotional regulation, and stress management. Participants' learning progress, questionnaire completion, and application use will be recorded through the study system.
干预措施: Internet-Based Cognitive Behavioral Therapy Program for Breast Cancer Survivors (Behavioral)
结局指标
主要结局
Change in Psychological Distress as Assessed by the Depression, Anxiety and Stress Scale-21
时间窗: Baseline to Week 9
Psychological distress will be assessed using the 21-item Depression, Anxiety and Stress Scale (DASS-21), which includes depression, anxiety, and stress subscales. Each item is rated on a 4-point scale from 0 to 3. Higher scores indicate greater levels of psychological distress. Changes in scores will be compared between the ICBT and TAU groups.
次要结局
- Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire-9(Baseline, Week 5, Week 9, and 3 months after the intervention period)
- Change in Post-Traumatic Stress Symptoms as Assessed by the Posttraumatic Diagnostic Scale for DSM-5(Baseline, Week 5, Week 9, and 3 months after the intervention period)
- Change in Life Satisfaction as Assessed by the Satisfaction With Life Scale(Baseline, Week 5, Week 9, and 3 months after the intervention period)
- Change in Insomnia Severity as Assessed by the Insomnia Severity Index(Baseline, Week 5, Week 9, and 3 months after the intervention period)
- Change in Fatigue as Assessed by the Brief Fatigue Inventory(Baseline, Week 5, Week 9, and 3 months after the intervention period)
- Change in Fear of Cancer Recurrence as Assessed by the 7-Item Fear of Cancer Recurrence Scale(Baseline, Week 5, Week 9, and 3 months after the intervention period)
- Change in Self-Compassion as Assessed by the Self-Compassion Scale(Baseline, Week 5, Week 9, and 3 months after the intervention period)
- Change in Post-Traumatic Growth as Assessed by the Posttraumatic Growth Inventory-X(Baseline, Week 5, Week 9, and 3 months after the intervention period)