Comparison of the Effectiveness of Acceptance and Commitment Therapy and Intensive Short-Term Dynamic Psychotherapy on Emotion Regulation, Shame and Perfectionism among Patients with Irritable Bowel Syndrome
Comparison of the Effectiveness of Acceptance and Commitment Therapy and Intensive Short-Term Dynamic Psychotherapy on Emotion Regulation, Shame and Perfectionism among Patients with Irritable Bowel Syndrome
Design
Randomized trial with two parallel intervention and one control group, one blind strain, randomized in replacement phase, 2 phase on 36 patients.
Settings and conduct
The sample group is selected from the medical centers including Pardis and Imam Reza clinics and Motahari and Faqihi hospitals in Shiraz. Then the questionnaires of emotion regulation, internal and external shame and perfectionism are implemented on them and 36 people who have low scores in these scales are selected. These people are randomly replaced in two experimental groups and one control group. After the completion of the treatment sessions and two months after the treatment, the questionnaires will be administered again.
Participants/Inclusion and exclusion criteria
Participants: Patients with irritable bowel syndrome over 20 years of age in Shiraz city in 2022 who obtained low scores in the tools used in the research.
Entry requirements: diagnosis of irritable bowel syndrome by a gastroenterologist, age group 20 to 45 years, female gender
Conditions of non-entry: having addiction, having psychological disorders, taking psychiatric drugs, suffering from heart and respiratory diseases
Intervention groups
Intervention group 1: group receiving acceptance and commitment therapy
Intervention group 2: the group receiving Intensive Short-Term Dynamic Psychotherapy
Main outcome variables
Increasing emotional regulation, reducing feelings of shame, reducing perfectionism
General information
Reason for update
Acronym
ACT and ISTDP
IRCT registration information
IRCT registration number:IRCT20220808055640N1
Registration date:2022-08-30, 1401/06/08
Registration timing:prospective
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Nooshin Barahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 7079
Email address
nooshinbarahimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Acceptance and Commitment Therapy and Intensive Short-Term Dynamic Psychotherapy on Emotion Regulation, Shame and Perfectionism among Patients with Irritable Bowel Syndrome
Public title
The Effectiveness of Acceptance and Commitment Therapy and Intensive Short-Term Dynamic Psychotherapy on Emotion Regulation, Shame and Perfectionism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Irritable Bowel Syndrome by a gastroenterologist
Age group 20 to 45 years
Exclusion criteria:
having an addiction
Having a psychological disorders
Psychiatric drug use
having heart and respiratory diseases
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
An interventional study with blinding participants is conducted to evaluate the effect of acceptance and commitment therapy and short-term dynamic psychotherapy on emotion regulation, shame and perfectionism in people with irritable bowel syndrome.The method of blinding the patients is that after explaining the research, the treatment is given to the two intervention groups, but the two intervention groups do not know which treatment they will receive.The control group will only receive explanations about the questionnaires and forms that contain the questionnaires used to measure the target variables during the pre-test and post-test. Also, patients do not know the nature of the intervention program implemented for the opposite groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand St., central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-06-08, 1401/03/18
Ethics committee reference number
IR.SUMS.REC.1401.293
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K90-K93
ICD-10 code description
Other diseases of the digestive system
Primary outcomes
1
Description
Emotion regulation score in Gratz & Roemer questionnaire
Timepoint
At the beginning of the study and 10 weeks after the start of the intervention
Method of measurement
Gratz & Roemer Difficulties in Emotion Regulation Scale
2
Description
Shame score in Cook's questionnaire and Gross et al.'s questionnaire
Timepoint
At the beginning of the study and 10 weeks after the start of the intervention
Method of measurement
Cook Internalized shame scale, Gross et al. Shame scale
3
Description
Perfectionism score in the Flett perfectionism scale
Timepoint
At the beginning of the study and 10 weeks after the start of the intervention
Method of measurement
Flett Perfectionism scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1, the group receiving acceptance and commitment therapy: Before the intervention, questionnaires were completed by people in the groups. Ten sessions of acceptance and commitment therapy were followed, one session per week and each session lasting about an hour, in a quiet room and according to a written schedule.In this research, the intervention programs of Hayes, 2008 and Dahl, Stewart, Martel and Kaplan, 2014 were adapted.First, in the form of solving general problems, and then solving specific problems and helping clients to recognize ineffective control strategies and realize their futility, accepting painful personal events without fighting with them, teaching the steps of acceptance, explaining the concept of values, creating motivation. It was done to change and train commitment to action that affect the regulation of emotions, feelings of shame and perfectionism of the subject group.The group had enough opportunity to achieve the goals of the research, and the subjects started with freedom of action and without any pressure from the therapist to express their emotions, feelings of shame and perfectionism. At the end of the training, the group was given a post-test and the questionnaires were filled again.
Category
Behavior
2
Description
Intervention group2, The group receiving short-term dynamic psychotherapy: before the implementation of the intervention, the questionnaires were completed by people in the groups. For the second experimental group, which were exposed to the experimental variable of short-term dynamic psychotherapy, ten sessions of a one-hour training program were designed based on the works of Dr. Habib Duvanlu (2000). Each part of the treatment consists of a series of intervention and response, which ultimately leads to the failure of resistance and the therapist and patient entering the dynamic and unconscious core of the disorder.The seven stages of the dynamic sequence are: questioning the patient's problem, pressure, challenge with resistance, manifestation of transference resistance and challenge with it, overcoming the therapeutic contract over resistance and conscious re-opening, analysis of transference and exploration of dynamics in the unconscious. At the end of the training, the group was given a post-test and the questionnaires were filled again.
Category
Behavior
3
Description
Control group, no intervention: no intervention was done on people. Questionnaires were filled by people at the beginning of the course and filled again at the end of the course.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Mani Ramzi
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3647 4673
Email
motahari@sums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Bijan Fazel Jahromi
Street address
Zand Blvd., next to the Faculty of Medicine
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
FaghihiHSP@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamyar Zomorrodian
Street address
Zand St., central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Islamic Azad University
Full name of responsible person
Nooshin Barahimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 1,No.45, Alley 12/5, Shaid beheshti Blvd.,
City
Shiraz
Province
Fars
Postal code
7145894373
Phone
+98 71 3627 7079
Fax
Email
nooshinbarahimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nooshin Barahimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 1,No.45, Alley 12/5, Shaid beheshti Blvd.,
City
Shiraz
Province
Fars
Postal code
7145894373
Phone
+98 71 3627 7079
Fax
Email
nooshinbarahimi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nooshin Barahimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 1,No.45, Alley 12/5, Shaid beheshti Blvd.,
City
Shiraz
Province
Fars
Postal code
7145894373
Phone
+98 71 3627 7079
Fax
Email
nooshinbarahimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Considering that the number of patients with irritable bowel syndrome in Fars province is limited, in order to prevent the possible identification of individuals based on their demographic characteristics, the data of these people will be prevented.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available