Effect of Acceptance and Commitment Therapy on Stigma in College Students With Irritable Bowel Syndrome: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Stigma
研究概览
简要总结
The purpose of this study was to construct a Stigma intervention program for college students with Irritable Bowel Syndrome (IBS) based on the Acceptance and Commitment Therapy (ACT) theory and to investigate the effectiveness in reducing stigma in IBS patients with the aim of enhancing their mental health and improving their quality of life.
详细描述
Using purposive sampling method, 84 college students with irritable bowel syndrome (IBS) accompanied by a sense of shame who met the inclusion and exclusion criteria from June 2023 to January 2024 in a comprehensive university in Yangzhou City were selected for the study. Using the method of random grouping, the patients who met the inclusion and exclusion criteria were numbered and randomly divided into the control group and the intervention group by computer random number procedure. Because individual patients fell out during the study, the final sample size for inclusion in the study was 80 cases, with 40 cases in each group. The control group was given conventional health education on irritable bowel syndrome, and the intervention group was given a 6-week acceptance and commitment therapy-based intervention programme for college students with irritable bowel syndrome based on stigma, with a 6-week intervention period and a 3-month follow-up period. The ANOVA of repeated measures data was used to analyse the trends in the Stigma, Psychological flexibility (PF), Self-acceptance (SA) and Quality of Life (QOL) score trends over time to assess the effects of the intervention. A single-blind method was used in this study, and only the outcomes assessor was blinded.
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)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with IBS who meet the Rome IV diagnostic criteria;
- •Duration of IBS disease≥0.5 years;
- •The Perceived Stigma Scale in IBS (PSS-IBS) total score≥80;
- •Patients can proficiently use WeChat and participate in remote follow-ups;
- •Understand the research content, participate voluntarily and sign the informed consent.
排除标准
- •Patients with other intestinal diseases or serious primary diseases;
- •Patients with comorbid psychiatric diseases;
- •Patients who engaged in psychological workers or received psychological counseling within 3 months;
- •Patients who have recently participated in or are currently participating in other similar studies.
结局指标
主要结局
Stigma
时间窗: Baseline, 1 and 3 months post-intervention
The Perceived Stigma Scale in IBS (PSS-IBS) was used to assess perceived stigma in terms of disease disclosure, attitude and knowledge about disease, disease efficacy, severity, and blame. The scale has 10 entries with 6 dimensions and is scored on a 5-point Likert scale from 0 to 4, with total scores ranging from 0 to 240, with the higher scores indicating the higher the level of perceived stigma. A score of 1 to 80 indicates mild, a score of 81 to 161 is moderate, and a score of \> 161 is severe.
次要结局
- Quality of Life (QOL)(Baseline, 1 and 3 months post-intervention)
- Psychological flexibility (PF)(Baseline, 1 and 3 months post-intervention)
- Self-acceptance (SA)(Baseline, 1 and 3 months post-intervention)
研究者
Gao Yajun
Principal Investigator
Yangzhou University