Clinical trial NCT06456710: Effect of a Psychological Intervention on Stigma: a Randomized Controlled Study
Official title: Effect of Acceptance and Commitment Therapy on Stigma in College Students With Irritable Bowel Syndrome: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Stigma
Psychological Intervention
Keywords: Irritable Bowel Syndrome
Stigma
Acceptance Commitment Therapy
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Stigma
timeFrame: Baseline, 1 and 3 months post-intervention
Secondary outcomes:
measure: Psychological flexibility (PF)
timeFrame: Baseline, 1 and 3 months post-intervention
measure: Self-acceptance (SA)
timeFrame: Baseline, 1 and 3 months post-intervention
measure: Quality of Life (QOL)
timeFrame: Baseline, 1 and 3 months post-intervention
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Yangzhou University
state: Jiangsu
Study officials:
affiliation: Yangzhou University
name: Yajun Gao, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dear BF, Scott AJ, Fogliati R, Gandy M, Karin E, Dudeney J, Nielssen O, McDonald S, Heriseanu AI, Bisby MA, Sharpe L, Jones MP, Ali S, Titov N. The Chronic Conditions Course: A Randomised Controlled Trial of an Internet-Delivered Transdiagnostic Psychological Intervention for People with Chronic Health Conditions. Psychother Psychosom. 2022;91(4):265-276. doi: 10.1159/000522530. Epub 2022 Apr 1.