Irritable Bowel SyndromeNCT06456710
Effect of a Psychological Intervention on Stigma: a Randomized Controlled Study
A study testing Conventional IBS Health Education and Based on ACT Theory of Psychological Intervention in people with Irritable Bowel Syndrome and Stigma, run by Yangzhou University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Irritable Bowel Syndrome, Stigma, Psychological Intervention
- What is being tested?
- Conventional IBS Health Education and Based on ACT Theory of Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Irritable Bowel Syndrome, Stigma, Psychological Intervention
- Being tested
- Conventional IBS Health Education, Based on ACT Theory of Psychological Intervention
- Keywords
- Irritable Bowel Syndrome, Stigma, Acceptance Commitment Therapy
- Medical subject headings
- Irritable Bowel Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional IBS Health EducationBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional IBS Health Education | Placebo comparator | 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. Receives: Behavioral: Conventional IBS Health Education |
| Based on ACT Theory of Psychological Intervention | Experimental | A psychological intervention program based on ACT theory was implemented on top of the control group. Receives: Behavioral: Based on ACT Theory of Psychological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 and 3 months post-intervention
Secondary outcomes (3)
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.
Measured: Baseline, 1 and 3 months post-intervention
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.
Measured: Baseline, 1 and 3 months post-intervention
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.
Measured: Baseline, 1 and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jun 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Yajun, Yangzhou University
- Investigators
- Yajun Gao, Master, Principal investigator, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456710
- Sponsor's protocol ID
- YZUHL20220044
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to provide IPD
Publications
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 Psychological Intervention for People with Chronic Health Conditions. Psychother Psychosom. 2022;91(4):265-276. doi: 10.1159/000522530. Epub 2022 Apr 1.
PubMed 35367986
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acceptance and Commitment Therapy on Stigma in College Students With Irritable Bowel Syndrome: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06456710
- Acronym / sponsor ID
- YZUHL20220044
- Conditions
- Irritable Bowel Syndrome, Stigma, Psychological Intervention
- Keywords
- Irritable Bowel Syndrome, Stigma, Acceptance Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional IBS Health Education | Placebo comparator | Behavioral: Conventional IBS Health EducationPatients 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 | Experimental | Behavioral: Based on ACT Theory of Psychological InterventionA psychological intervention program based on ACT theory was implemented on top of the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional IBS Health EducationPatients 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. | Behavioural | Conventional IBS Health Education |
| Based on ACT Theory of Psychological InterventionOn 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. | Behavioural | Based on ACT Theory of Psychological Intervention |
Primary outcome
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.
3 secondary outcomes
Psychological flexibility (PF)
Time frame: Baseline, 1 and 3 months post-intervention
Self-acceptance (SA)
Time frame: Baseline, 1 and 3 months post-intervention
Quality of Life (QOL)
Time frame: Baseline, 1 and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Results publication: PubMed 35367986Dear 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 Psychological Intervention for People with Chronic Health Conditions. Psychother Psychosom. 2022;91(4):265-276. doi: 10.1159/000522530. Epub 2022 Apr 1.
- Individual participant dataSharing planned: No. No plans to provide IPD
Related trials for Irritable Bowel Syndrome
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Not yet recruiting
NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yajun Gao, Master principal investigator
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional IBS Health Education and Based on ACT Theory of Psychological Intervention in people with Irritable Bowel Syndrome and Stigma, run by Yangzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stigma (time frame: Baseline, 1 and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024; AzTrials last refreshed its copy on 2 Nov 2026.