Effect of a Psychological Intervention on Stigma: a Randomized Controlled Study

Yangzhou University

Status: Completed

Conditions: Irritable Bowel Syndrome; Psychological Intervention; Stigma

Treatments: Behavioral: Conventional IBS Health Education; Behavioral: Based on ACT Theory of Psychological Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06456710

YZUHL20220044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Conventional IBS Health Education

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Conventional IBS Health Education

Based on ACT Theory of Psychological Intervention

Experimental group

Description:

A psychological intervention program based on ACT theory was implemented on top of the control group.

Treatment:

Behavioral: Based on ACT Theory of Psychological Intervention