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临床试验/NCT06473636
NCT06473636已完成不适用

Mindfulness Training Improves Depression Among Female Abdominal Cancer Patients Through Improving Cognitive Emotion Regulation and Emotional State

Zunyi Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:
适应症

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
The change from baseline Positive and Negative Affect Scale at post-training

研究概览

简要总结

We first explored the effect of mindfulness training on depression in patients with abdominal cancer. Then the effects of cognitive emotion regulation and emotional state in the training effect were examined. Sixty patients with abdominal cancer were recruited from a hospital and divided into two groups: the mindfulness group (n=30) who received a four-week mindfulness training program, and the control group (n=30) who received only one mindfulness lecture. All participants were assessed using the Mindful Attention Awareness Scale, Cognitive Emotion Regulation Strategy Questionnaire, Positive and Negative Affect Scale, and depression subscale of the Patient Health Questionnaire before and after the mindfulness training program.

详细描述

Participants Sixty patients with abdominal cancer from a hospital were recruited. All patients were divided into a mindfulness group (n=30) who received a four-week mindfulness training program and a control group (n=30) who received only one mindfulness lecture over four weeks. No age difference was found between the mindfulness group (M=53.87, SD=10.31, ranging from 35 to 75) and the control group (M=52.73, SD=7.27, ranging from 42 to 69), t(58) =0.49, p=0.625. The participants were all women and none of them reported a history of neurological or psychiatric illness.

Ethics approval statement All procedures involving human participants in this study were conducted in strict accordance with the ethical standards of the Ethical Committee at a medical university, as well as the 1964 Helsinki Declaration and its subsequent amendments, or any comparable ethical standards. All participants gave informed consent before participating. Furthermore, following the completion of the study, the control group could also undergo the same mindfulness training program if they volunteered.

Measurements Mindful Attention Awareness Scale. It contains 15 items in a single dimension. All of the items are rated on a 7-point Likert scale from 1 ("strongly agree") to 7 ("strongly disagree"). Higher scores reflect a higher level of trait mindfulness and awareness of the present moment. The Cronbach's α was 0.89 and the two-week test-retest reliability was 0.87 in the Chinese sample. The Cronbach's α coefficient of the scale in the present study was 0.87.

The Patient Health Questionnaire. Its depression subscale consists of 9 items. All of the items are rated on a 4-point Likert scale from 1 ("strongly disagree") to 4 ("strongly agree"). Higher scores indicate a greater level of depression. The Cronbach's α was 0.86 and the two-week test-retest reliability was 0.86 in the Chinese sample. The Cronbach's α coefficient of the scale in the present study was 0.87.

The Cognitive Emotion Regulation Questionnaire. It consists of 36 items and nine subscales. These subscales assess various strategies employed in cognitive emotion regulation, such as self-blame, blaming others, acceptance, refocus on planning, positive refocusing, rumination or focus on thought, positive reappraisal, putting into perspective, and catastrophizing. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events. Adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the acceptance, putting into perspective, refocus on planning, positive refocusing, and positive reappraisal subscales. Non-adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the self-blame, blaming others, rumination or focus on thought, and catastrophizing subscales. In the Chinese samples, the Cronbach's α coefficients for these subscales ranged from 0.48 to 0.89. The Cronbach's α coefficients of the adaptive and non-adaptive cognitive emotion regulation strategies subscales in the present study were 0.84 and 0.74 respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with abdominal cancer; female; over 19 years old

排除标准

  • a history of neurological or psychiatric illness; intellectual or speech disorders

结局指标

主要结局

The change from baseline Positive and Negative Affect Scale at post-training

时间窗: Baseline (Day 0)/Post-training (Month 1)

It contains 20 items and consists of two self-report subscales including positive emotions and negative emotions. All of the items are rated on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). The higher the score, the stronger the emotions in a certain dimension.

The change from baseline Mindful Attention Awareness Scale at post-training

时间窗: Baseline (Day 0)/Post-training (Month 1)

It contains 15 items in a single dimension. All of the items are rated on a 7-point Likert scale from 1 ("strongly agree") to 7 ("strongly disagree"). Higher scores reflect a higher level of trait mindfulness and awareness of the present moment.

The change from baseline Cognitive Emotion Regulation Questionnaire at post-training

时间窗: Baseline (Day 0)/Post-training (Month 1)

It consists of 36 items and nine subscales. These subscales assess various strategies employed in cognitive emotion regulation, such as self-blame, blaming others, acceptance, refocus on planning, positive refocusing, rumination or focus on thought, positive reappraisal, putting into perspective, and catastrophizing. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events.

The change from baseline Patient Health Questionnaire at post-training

时间窗: Baseline (Day 0)/Post-training (Month 1)

Its depression subscale consists of 9 items. All of the items are rated on a 4-point Likert scale from 1 ("strongly disagree") to 4 ("strongly agree"). Higher scores indicate a greater level of depression.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kou Hui

Principal Investigator

Zunyi Medical College

研究点 (1)

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