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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome Stigma Psychological Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Conventional IBS Health Education

Intervention Type 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.

Based on ACT Theory of Psychological Intervention

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

Group Type EXPERIMENTAL

Based on ACT Theory of Psychological Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No