Effect of Acceptance and Commitment Therapy on Stigma in College Students With Irritable Bowel Syndrome: a Randomized Controlled Study
Phase: NA
Conditions: Irritable Bowel Syndrome, Stigma, Psychological Intervention
Sponsor: Yangzhou University

Effect of acceptance and commitment therapy
on stigma in college students with irritable
bowel syndrome: a randomized controlled study
October 18, 2022

Study Protocol
1. Integrity Statement
(1) Ensure that the operation is in strict accordance with the test protocol and the
authenticity of the data records; (2) No conflict of interest with other projects.
2. Title of the study
Effect of acceptance and commitment therapy on stigma in college students with
irritable bowel syndrome: a randomized controlled study
3. Flow chart of the implementation of the study

Specific implementation contents ofthe intervention programme
Module topics
Module objectives
Intervention contents
Homework
Week 1
Building relationships
understanding ACT
Understanding the ACT
content
1. The researcher and the patient introduce themselves, get to
know each other and establish a good relationship. (5 minutes)
2. Understand the patient's psychological state and encourage each
patient to tell their experience of IBS, their views on IBS and their
knowledge of IBS health. (10 minutes)
3. Introduce the six core components of ACT and the treatment
process, and explain the application of ACT to help patients
realize that they can improve their current psychological state and
enhance their confidence through intervention. (15 minutes)
4. Teach patients to mindfulness breathing. (10 minutes)
5. Live answer: answer patients' questions and start a discussion.
(10 minutes)
Perform
1-2
10-minute
Positive
Breathing
Exercises
per
day
and
record a video to upload to
WeChat group.
Week 2
Acceptance of disease
Positive acceptance
Abandon confrontation
1. Live discussion: encourage patients to express their thoughts,
describe the reasons for their worries or fears, their inner feelings,
etc., after experiencing the disease, and share the measures taken
to cope with these thoughts or feelings and their effects. (10
minutes)
2. Live video broadcast: explain the metaphor of "Tug-of-War
with Monsters" to convey to patients that in difficult situations,
the more they struggle, the worse the situation will be, and to
promote the acceptance of negative emotions by patients, and to
correctly face the disease and pain. "Struggle Switch": give up the
struggle against physical and emotional pain and accept the true
feelings. (20 minutes)
Patients are encouraged to
keep a diary every day, take
photos and upload them to
email
to
exchange
ideas
with
researchers.
Record
your struggles with painful
thoughts or emotions and
think about how cognitive
dissociation
strategies
should be used to regulate
emotions.

(Continued)
Module topics
Module objectives
Intervention contents
Homework
3. Establish correct knowledge of IBS and acceptance of IBS. Tell
patients to face painful experiences with an open attitude of
acceptance, avoidance will only deepen the bondage of suffering.
(10 minutes)
4. Live answer: answer patients' questions and start a discussion.
(10 minutes)
Week 3
Cognitive dissociation
Reducing the problematic
dominance of patient cognition
over behavior
1. Explaining to patients the importance of rationally coping with
negative emotions, carrying out cognitive dissociation exercises,
helping patients to identify "thoughts" and "reality", and making
patients realize that "thoughts" are not "facts per se", and guiding
patients to normalize their painful emotions by separating negative
thoughts from reality. (10 minutes)
2. Live video: "I am having this thought" exercise to reduce or get
rid of emotional pain. (20 minutes)
3. Use the metaphor of "leaves floating down the stream" to help
patients separate the ideal from the reality, so that they can learn
to look at the stigma of IBS from an observer's point of view with
a more relaxed mindset, and not to get caught up in it. (10
minutes)
4. Live answer: answer patients' questions and start a discussion.
(10 minutes)
Practice "Leaves Floating
in the Stream" every day,
write
down
your
own
experience, take photos and
upload them to email to
exchange
ideas
with
researchers.
Week 4
Self-awareness
Focus on the present
Dissociation from the
conceptualized self
1. Change the patient's concept of "self" and guide the patient to
positively accept IBS. (10 minutes)
2. Conduct a "checkerboard metaphor" exercise to guide patients
Patients
are
guided
to
empty themselves, to be in
the present moment, to be

(Continued)
Module topics
Module objectives
Intervention contents
Homework
to focus on their lives in the present, accept their own emotions,
and pay attention to their true selves in the present moment. (20
minutes)
3.
Facilitate
self-expression
without
being
held
back
by
conceptualizations of self or others. (10 minutes)
4. Live discussion: think about the changes brought about by IBS
and guide patients to practice body scanning. (10 minutes)
consciously aware of their
thoughts, to think about the
changes brought about by
the illness, and to record
them.
Week 5
Clarifying value
Defining values
Focus on your core values
1. Introduce the values in ACT, use interviews with IBS patients
to help them clarify their values, guide them to identify "what is
most important to them", and develop a list of goals based on their
own values and use them as goals and directions for action. (10
minutes)
2. Picture display: using the metaphor of "Donkey, Stick and
Carrot" to introduce values. (10 minutes)
3. Compass Metaphor: work with the patient to understand the
importance of values and to guide patients to develop confidence
in improving levels based on their own values. (20 minutes)
4. Live answer: answer patients' questions and start a discussion.
(10 minutes)
Write out their own value
goals, reflect on the values,
and share ideas with the
researcher and peers during
the
next
intervention
session.
Week 6
Committed action
Moving on
Guided by values toward a
meaningful life
1. Introduce the importance of commitment to action: according to
their own values, guide patients to clarify "what kind of person
they want to be", think about the goals they want to achieve, and
consider the problems and solutions they may encounter in the
process of implementation, and help them to develop a practical
Encourage patients to think
about what they want to
achieve.
What
is
the
specific
process
for
achieving it?

(Continued)
Module topics
Module objectives
Intervention contents
Homework
plan together. (10 minutes)
2. Set SMART behavioral goals: S-Specific; M-Measurable;
A-Achievable; R-Realistic; T-Time-bound. (10 minutes)
3. Live discussion: summarize and review the whole process of
the ACT intervention, and invite each member to share their own
gains and feelings during the intervention. (10 minutes)
4. Encourage each member to strengthen the use of ACT in their
future study and life. (15 minutes)

4. Background
Acceptance and commitment therapy (ACT), as a new cognitive intervention therapy,
emphasizes value-oriented goal setting, which mainly includes six core processes:
acceptance, cognitive dissociation, experiencing the present moment, self-as-context,
clarifying values and committed action, which is conducive to solving the
psychological disturbances existing in patients with chronic pain, HIV, cancer,
epilepsy, irritable bowel syndrome, etc., and increasing the degree of self-acceptance
and reducing the stigma of illness. Through diverse therapeutic approaches,
psychological flexibility is increased and the impact of unrealistic thoughts on daily
life and goal achievement is limited. There are many reports of domestic studies
related to ACT on reducing the sense of shame in patients with chronic diseases, but
there have been no intervention studies on ACT to reduce the sense of shame in
patients with IBS, and there is a lack of applied research on systematic intervention
programs. Therefore, in this study, we used ACT as the basis for developing an
intervention program to reduce the stigma, and explored the effectiveness of ACT in
reducing the stigma in IBS patients, with the aim of enhancing their mental health and
improving their quality of life.
5. Research purpose
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.
6. Inclusion and Exclusion Criteria
Inclusion criteria: (1) Patients with IBS who meet the Rome IV diagnostic criteria; (2)
Duration of IBS disease≥0.5 years; (3) The Perceived Stigma Scale in IBS (PSS-IBS)
total score≥80; (4) Patients can proficiently use WeChat and participate in remote
follow-ups; (5) Understand the research content, participate voluntarily and sign the

informed consent. Exclusion Criteria: (1)Patients with other intestinal diseases or
serious primary diseases; (2) Patients with comorbid psychiatric diseases; (3) Patients
who engaged in psychological workers or received psychological counseling within 3
months; (4) Patients who have recently participated in or are currently participating in
other similar studies.
7. Intervention process
From June 2023 to January 2024, college students with irritable bowel syndrome (IBS)
accompanied by a sense of shame who met the inclusion and exclusion criteria were
selected from a comprehensive university in Yangzhou City. The control group
implemented conventional health education on IBS, and the intervention group
implemented psychological intervention program based on ACT theory on top of the
control group.
8. Sample size estimation
The required sample size was calculated by comparing the means of the two samples,
applying the following formula: n=2[(Zα/2+Zβ)σ/δ]2, the test level was taken as
two-sided α=0.05 and β=0.10, which resulted in µα=1.96, and µβ=1.282, the
two-sided test was used, reviewing the literature, σ=5.15 and δ=4.01, the calculation
was made that n1=n2=35 cases, and the 20% loss of visit rate was considered. Finally,
there were 42 cases in each group, and the total sample size was 84 cases. In the
process of the study, there were 2 cases of lost visits in the control group, of which 1
case withdrew in the middle of the study and 1 case was interrupted; there were 2
cases of lost visits in the intervention group, of which 1 patient withdrew due to
aggravation of the disease and 1 case was interrupted, and the final sample size
included in the statistical analysis was 80 cases, with 40 cases in each group.
9. Randomisation
Participants were identified through related questionnaire survey, and participants
signed a written consent form to participate in the study. After the baseline assessment,
using a randomized grouping approach, patients who met the inclusion and exclusion

criteria were numbered and randomly divided into a control group and an intervention
group by a computerized random number procedure.
10. Measurement index
General information questionnaire: baseline (T0); perceived stigma scale in IBS
(PSS-IBS) (primary indicator): baseline (T0), 1 month post intervention (T1), 3months
post intervention (T2); acceptance and action questionnaire-II (AAQ-II) (secondary
indicator): baseline (T0), 1 month post intervention (T1), 3months post intervention
(T2); self-acceptance questionnaire (SAQ) (secondary indicator): baseline (T0), 1
month post intervention (T1), 3months post intervention (T2); IBS quality of life
(IBS-QOL) (secondary indicator): baseline (T0), 1 month post intervention (T1),
3months post intervention (T2).
11. Ethical consideration
The study was ethically approved by the Ethics Committee of the College of Nursing
of Yangzhou University (YZUHL20220044).
12. Statistical analysis of data
SPSS 25.0 software was applied for data analysis. Measurement data conforming to
normal distribution were described by mean ± standard deviation, those not
conforming to normal distribution were described by median (inter-quartile spacing),
and count data were expressed by frequency and constitutive ratio. The t-test was used
for between-group comparison of measures that met normal distribution, the
Mann-Whitney U test was used for between-group comparison of measures that did
not meet normal distribution, the χ2 test was used for categorical variables, and
Mauchly's test of sphericity was used, and if the covariance matrix did not satisfy the
sphericity symmetry, the correction coefficient (Epsilon) was used to correct for the
degrees of freedom, and the Greenhouse-Geisser was used for correcting results.
Trends in PSS-IBS, AAQ-II, SAQ, and IBS-QOL scores over time were analyzed
using ANOVA of repeated measures data for both study groups at pre-intervention, 1
month post-intervention, and 3 months post-intervention.