Effects of Cognitive Behavioral Therapy-Based Intervention on Depression, Anxiety, Quality of Life, Immune Indicators, and Survival Among Patients With Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in depression symptoms at 6 months
研究概览
简要总结
This study investigates the effects of a CBT- based intervention on depression, anxiety, immune function, quality of life, and overall survival. It also explores if the effects of the intervention on immune function and quality of life are mediated through the improvements in depression and anxiety among patients with liver cancer.
详细描述
In the present research project, the investigators have developed a Cognitive Behavioral Therapy (CBT)-based intervention protocol to investigate the impact of this intervention on depression, anxiety, quality of life, immune function, and overall survival in patients diagnosed with liver cancer. Additionally, this research protocol aims to examine the hypothesized mechanisms underlying the effects of the CBT-based intervention on quality of life and immune function. Specifically, we will investigate: 1) whether the effect of the CBT-based intervention on quality of life is mediated by improvements in anxiety and depression, and 2) whether the effect of the CBT-based intervention on immune function is mediated by improvements in anxiety and depression among patients with liver cancer.
A total of 160 participants will be recruited and randomly assigned to either the CBT-based intervention group or an educational group receiving non-psychological interventions. Assessments will be conducted at baseline (pre-treatment) and at 3, 6, and 12 months after the intervention period. Survival data will be collected throughout the follow-up period until the patients' end-of-life.
By examining the effects of the CBT-based intervention on multiple outcomes and exploring the potential mediating mechanisms, this research project aims to contribute to a comprehensive understanding of the intervention's effectiveness and its impact on the well-being of liver 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
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
We will ensure that the assessors are unaware of the treatment assignments or intervention details for each participant. We will use anonymized coded data that does not reveal the group allocation during the outcome assessment. The data will be presented in a standardized format that prevents any identification of treatment groups.
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
- •Adults (aged ≥18);
- •Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record;
- •The severity level of depression and anxiety: Depression > 7 using HAD-D, or Anxiety > 7 using HAD-A (Hospital Anxiety and Depression Scale, HADS; HAD-D, Hospital Depression Scale; HAD-A, Hospital Anxiety Scale).
排除标准
- •Patients who are taking part in another psychological intervention clinical trial or consented to receive another psychotherapy, suffered from aphasia and other communication difficulties will be excluded from the study
- •Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases.
- •Patients accepting hormone therapy or taking long-term antibiotic drugs.
- •Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.
结局指标
主要结局
Change in depression symptoms at 6 months
时间窗: T2(6 months)
Change in participants' depression score with the HADS depression subscale from baseline to 6 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
Change in depression symptoms at 12 months
时间窗: T3(12 months)
Change in participants' depression score with the HADS depression subscale from baseline to 12 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
Change in anxiety symptoms at 3 months
时间窗: T1(3 months)
Change in participants' anxiety score with the HADS anxiety subscale from baseline to 3 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Change in depression symptoms at 3 months
时间窗: T1(3 months)
Change in participants' depression score with the HADS depression subscale from baseline to 3 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
Anxiety symptoms at baseline
时间窗: T0(Baseline)
Participants' anxiety score with the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Change in anxiety symptoms at 12 months
时间窗: T3(12 months)
Change in participants' anxiety score with the HADS anxiety subscale from baseline to 12 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Depression symptoms at baseline
时间窗: T0(Baseline)
Participants' depression score with the depression subscale of the Hospital depression and Depression Scale (HADS). The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.
Change in anxiety symptoms at 6 months
时间窗: T2(6 months)
Change in participants' anxiety score with the HADS anxiety subscale from baseline to 6 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
次要结局
- Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months(T1(3 months))
- Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months(T3(12 months))
- Change in Immune variables 4 at 6 months(T2(6 months))
- Immune variables 5 at baseline(T0(Baseline))
- Quality of life score (The EORTC QLQ-C30) at baseline(T0(Baseline))
- Change in Quality of life score (The EORTC QLQ-C30) at 6 months(T2(6 months))
- Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months(T2(6 months))
- Change in Quality of life score (The EORTC QLQ-C30) at 3 months(T1(3 months))
- Change in Quality of life score (The EORTC QLQ-C30) at 12 months(T3(12 months))
- Quality of life score (The EORTC QLQ-HCC18) at baseline(T0(Baseline))
- Immune variables 1 at baseline(T0(Baseline))
- Immune variables 3 at baseline(T0(Baseline))
- Change in Immune variables 3 at 3 months(T1(3 months))
- Change in Immune variables 5 at 6 months(T2(6 months))
- Overall survival(T3 (12 months) and later till the end of life.)
- Change in Immune variables 1 at 3 months(T1(3 months))
- Change in Immune variables 2 at 3 months(T1(3 months))
- Change in Immune variables 2 at 6 months(T2(6 months))
- Change in Immune variables 4 at 3 months(T1(3 months))
- Change in Immune variables 1 at 6 months(T2(6 months))
- Immune variables 2 at baseline(T0(Baseline))
- Change in Immune variables 3 at 6 months(T2(6 months))
- Immune variables 4 at baseline(T0(Baseline))
- Change in Immune variables 5 at 3 months(T1(3 months))
研究者
Hua Yin
Principal Investigator
The Nethersole School of Nursing