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
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
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Jiangsu
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Yangzhou, Jiangsu, China, 225000
- Yangzhou University
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-
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.
|
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.
|
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.
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Baseline, 1 and 3 months post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
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
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