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Clinical Trials/NCT06456710
NCT06456710
Completed
Not Applicable

Effect of Acceptance and Commitment Therapy on Stigma in College Students With Irritable Bowel Syndrome: a Randomized Controlled Study

Yangzhou University1 site in 1 country80 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
Yangzhou University
Enrollment
80
Locations
1
Primary Endpoint
Stigma
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
January 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yangzhou University
Responsible Party
Principal Investigator
Principal Investigator

Gao Yajun

Principal Investigator

Yangzhou University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Stigma

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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