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

June 10, 2024 updated by: Gao Yajun, Yangzhou University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225000
        • Yangzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Behavioral: 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.
Experimental: Based on ACT Theory of Psychological Intervention
A psychological intervention program based on ACT theory was implemented on top of the control group.
Behavioral: Based on ACT Theory of Psychological Intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological flexibility (PF)
Time Frame: 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.
Baseline, 1 and 3 months post-intervention
Self-acceptance (SA)
Time Frame: 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.
Baseline, 1 and 3 months post-intervention
Quality of Life (QOL)
Time Frame: 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.
Baseline, 1 and 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangzhou University

Investigators

  • Principal Investigator: Yajun Gao, Master, Yangzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZUHL20220044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to provide IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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