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

NCT06456710 | Completed DMC

• 1 other identifier: YZUHL20220044
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Stigma; Psychological Intervention

Keywords

Irritable Bowel Syndrome; Stigma; Acceptance Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• Stigma

  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.

  Baseline, 1 and 3 months post-intervention

Secondary Outcomes (3)

• Psychological flexibility (PF)

  Baseline, 1 and 3 months post-intervention

• Self-acceptance (SA)

  Baseline, 1 and 3 months post-intervention

• Quality of Life (QOL)

  Baseline, 1 and 3 months post-intervention

Study Arms (2)

Conventional IBS Health Education

PLACEBO COMPARATOR

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.

Behavioral: Conventional IBS Health Education

Based on ACT Theory of Psychological Intervention

EXPERIMENTAL

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

Behavioral: Based on ACT Theory of Psychological Intervention

Interventions

Conventional IBS Health Education BEHAVIORAL

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.

Conventional IBS Health Education

Based on ACT Theory of Psychological Intervention BEHAVIORAL

On the basis of the control group, the stigma intervention program of college students with IBS based on ACT theory was implemented. The duration of intervention was 40 to 50 minutes for 6 times, once a week for 6 weeks. Week1: established relationships; introduced the core contents of ACT, the treatment process, and the effects of application. Week2: encouraged to express negative emotions and behaviors; made patients accept the disease. Week3: explained the importance of coping with negative emotions; instructed to separate negative thoughts from reality through cognitive dissociation exercises. Week4: changed the concept of "self" and actively accepted IBS; guided to focus on the current life and true self. Week5: introduced the values in ACT; helped clarify the values; guided to build confidence and focused on the core values. Week6: introduced the importance of commitment to action; developed goals and plans together; encouraged to strengthen the use of ACT.

Based on ACT Theory of Psychological Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Yangzhou University

Yangzhou, Jiangsu, 225000, China

Location

Related Publications (1)

• 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.

  PMID: 35367986 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Social Stigma

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Social Behavior; Behavior

Study Officials

• Yajun Gao, Master

  Yangzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)