Trials / Completed
CompletedNCT06456710
Effect of a Psychological Intervention on Stigma: a Randomized Controlled Study
Effect of Acceptance and Commitment Therapy on Stigma in College Students With Irritable Bowel Syndrome: a Randomized Controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Yangzhou University · Academic / Other
- Sex
- All
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2024-01-31
- Completion
- 2024-01-31
- First posted
- 2024-06-13
- Last updated
- 2024-06-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06456710. Inclusion in this directory is not an endorsement.