Comparison of the effectiveness of integrated transdiagnostic therapy(UP) and acceptance and commitment therapy(ACT) on rumination, life satisfaction, treatment citizenship, emotional disorders, gastrointestinal symptoms and perceived stress in patients with irritable bowel syndrome(IBS)
Determining the difference between the effectiveness of integrated transdiagnostic therapy with acceptance and commitment therapy on rumination, life satisfaction, treatment citizenship, emotional disorders, gastrointestinal symptoms and perceived stress in patients with irritable bowel syndrome
Design
The clinical trial study has two experimental groups, single blind, randomized and performed on 40 people. Simple randomization is used for randomization. The website https://www.Randomization.com is used online for random allocation. Numbered, sealed envelopes are used for blinding.
Settings and conduct
The present study is a clinical trial study with pre-test, post-test and follow-up that will be performed in patients diagnosed with irritable bowel syndrome in Taleghani Hospital. Samples are identified by a gastroenterologist after a definitive diagnosis and referred to a clinical psychologist. The clinical psychologist randomly places patients into two groups of 20, then treats each person individually online. Therapeutic intervention sessions are performed in a very similar manner and based on a single protocol.
Participants/Inclusion and exclusion criteria
Having a diagnosis of irritable bowel syndrome; age over 18 years old; having at least a third grade of secondary education; conscious satisfaction with conducting research
Intervention groups
Intervention group 1: includes patients with irritable bowel syndrome who receive integrated transdiagnostic treatment intervention in 10 sessions. Intervention group 2: includes patients with irritable bowel syndrome who receive the intervention of acceptance and commitment treatment in 8 sessions
Comparison of the effectiveness of integrated transdiagnostic therapy(UP) and acceptance and commitment therapy(ACT) on rumination, life satisfaction, treatment citizenship, emotional disorders, gastrointestinal symptoms and perceived stress in patients with irritable bowel syndrome(IBS)
Public title
Comparison of the effectiveness of integrated transdiagnostic therapy (UP) and acceptance and commitment therapy (ACT) on rumination, life satisfaction, treatment citizenship, emotional disorders, gastrointestinal symptoms and perceived stress in patients with irritable bowel syndrome (IBS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of irritable bowel syndrome
Age over 18 years old
Conscious satisfaction with conducting research
Having at least a third grade of secondary education
Exclusion criteria:
Three consecutive absences in treatment sessions
Reluctance to continue the treatment process
Incompleteness of one of the questionnaires, in which case the rest of the questionnaires related to that person will be deleted
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to avoid the effect of restrictive variables, after randomly selecting the subjects and examining the criteria for entering the research, the samples of the two groups in terms of contextual variables (age, sex, education, marriage) try to be matched and thus They are included in the study and in each group, the treatment is performed as a single blind that patients are not aware of the treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences, next to the University Headquarters, Shahid Chamran Evin Highway,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-04-12, 1401/01/23
Ethics committee reference number
IR.SBMU.MSP.REC.1401.005
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Score of Intensity of Gastrointestinal Symptoms in questionnaire (GSRS)
Timepoint
At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention
Method of measurement
Questionnaire of Intensity of Gastrointestinal Symptoms (GSRS)
2
Description
Perceived Stress Score in Cohen Questionnaire
Timepoint
At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention
Method of measurement
Cohen Perceived Stress Questionnaire
3
Description
Adherence of Medication Score in Morisky scale
Timepoint
At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention
Method of measurement
Morisky Medication Adherence Scale
4
Description
Life Satisfaction Score in Diener Questionnaire
Timepoint
At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention
Method of measurement
Diener Life Satisfaction Questionnaire
5
Description
Rumination-Reflection Score in Nolen-Hoeksema and Morrow Scale
Timepoint
At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention
Method of measurement
Rumination-Reflection Scale
6
Description
Depression and Anxiety and Stress Score in Antony Scale DASS-21
Timepoint
At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention
Method of measurement
Depression and Anxiety and Stress Scale Antony (dass-21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: includes patients with irritable bowel syndrome who receive integrated transdiagnostic treatment intervention in 10 sessions. The content of the first session includes increasing motivation to participate in treatment, motivational interview for patient participation and involvement, presenting the logic of treatment and setting treatment goals. Emotional experiences and AR model (history, responses, outcomes). The content of the third and fourth sessions includes teaching emotional awareness, learning to observe emotional experiences (emotions and reacting to emotions), especially using mindfulness techniques. The content of the fifth session includes re-evaluation and cognitive re-evaluation. Creating awareness of the impact and interrelationship between thoughts and emotions, identifying automatic maladaptive evaluations and cognitive re-evaluation and increasing flexibility in thinking. The content of the sixth and seventh sessions includes identifying patterns of emotion avoidance and examining emotion-induced behaviors. Familiarity and identification of emotion-induced behaviors and understanding their impact on emotional experiences, identifying maladaptive EDBS, and developing alternative action tendencies by coping with behaviors. The content of the eighth body includes awareness and tolerance of physical feelings. Increasing awareness of the role of physical feelings in emotional experiences, performing physiological visceral exposure or confrontation exercises in order to be aware of physical feelings and increase tolerance of these symptoms. The content of the ninth and tenth sessions includes visceral confrontation and confrontation with emotion based on situation, learning about the logic of emotional dreams, teaching how to prepare the hierarchy of fear and avoidance and designing repetitive and effective emotional confrontation exercises visually and objectively and inhibition. Avoid. Session 11 and 12: Prevention of recurrence. Overview of treatment concepts and discussion of the patient's recovery and therapeutic progress.
Category
Treatment - Other
2
Description
Intervention group 2: includes patients with irritable bowel syndrome who receive the intervention of acceptance and commitment treatment in 8 sessions.The content of the first session includes establishing a therapeutic relationship and an overall assessment.The content of the second session includes creative helplessness, exploring the world inside and out, and understanding that control is the problem, not the solution. The content of the third session includes identifying individual values, specifying values, practices, and barriers. The content of the fourth session includes examining one's values and using relevant metaphors. The content of the fifth session includes examining fusion and faulting and performing exercises for faulting using metaphor.The content of the sixth session includes explaining the concepts, role and context, observing oneself as a context. The content of the seventh session includes emphasizing the present and presenting an instruction on the effective use of the present and the present.The content of the eighth session includes commitment training, reviewing life stories, identifying behavioral plans according to values, and summarizing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Department of Taleghani Hospital
Full name of responsible person
Amirsam Kianimghadam
Street address
Shahid Beheshti University of Medical Sciences - next to Taleghani Hospital - Yemen Street - Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
as.kianimoghadam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsin Zarghi
Street address
Vice-Chancellor of Research Affairs,Shahid Beheshti University of Medical Sciences, Next to Taleghani hospital, Erabi Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl-office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirsam Kianimghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University of Medical Sciences - next to Taleghani Hospital - Yemen Street - Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
as.kianimghadam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirsam Kianimghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University of Medical Sciences - next to Taleghani Hospital - Yemen Street - Shahid Chamran Highway