Effect of a Psychological Intervention on Stigma: a Randomized Controlled Study
- Conditions
- Psychological InterventionStigmaIrritable Bowel Syndrome
- Interventions
- Behavioral: Conventional IBS Health EducationBehavioral: Based on ACT Theory of Psychological Intervention
- Registration Number
- NCT06456710
- Lead Sponsor
- Yangzhou University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional IBS Health Education Conventional IBS Health Education Patients were provided with IBS related knowledge (e.g., the pathogenesis of IBS and the reasons affecting the treatment effect), exercise guidance, drug guidance and dietary management precautions; and timely answers to patients' clinical problems and psychological support. Based on ACT Theory of Psychological Intervention Based on ACT Theory of Psychological Intervention A psychological intervention program based on ACT theory was implemented on top of the control group.
- Primary Outcome Measures
Name Time Method Stigma 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.
- Secondary Outcome Measures
Name Time Method Quality of Life (QOL) Baseline, 1 and 3 months post-intervention IBS quality of life (IBS-QOL) consisted of 34 items with 8 dimensions, namely, anxiety, behavior disorder, body ideation, health worry, food avoidance, social function, sexual behavior, and interpersonal relationship. The scale adopts Likert's 5-point scale, with scores ranging from 1-5 from the lowest to the highest. The score of each dimension is converted by the formula to make the value range from 0 to 100. The higher the score, the better the quality of life.
Psychological flexibility (PF) Baseline, 1 and 3 months post-intervention Acceptance and Action Questionnaire-II (AAQ-II) was used to assess the patients' level of psychological flexibility. The scale consists of 7 entries and is scored on a 7-point Likert scale from 1 to 7, with total scores ranging from 7 to 49. The higher the score, the lower the psychological flexibility, the higher the degree of empirical avoidance.
Self-acceptance (SA) Baseline, 1 and 3 months post-intervention Self-Acceptance Questionnaire (SAQ) consists of two dimensions (self-acceptance and self-evaluation) with a total of 16 entries. The scale is scored on a 4-point Likert scale from 1 to 4, with total scores ranging from 16 to 64. A higher score indicates a higher level of self-acceptance.
Trial Locations
- Locations (1)
Yangzhou University
🇨🇳Yangzhou, Jiangsu, China