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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06456710
• Other study ID #: YZUHL20220044
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2024
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Psychological Intervention
• Stigma
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

References & 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 Psycholog — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Psychological flexibility (PF)	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
Secondary	Self-acceptance (SA)	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
Secondary	Quality of Life (QOL)	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