Comparison of the efficacy of schema therapy and mindfulness-based cognitive therapy on symptoms, anxiety sensitivity and sleep quality in patients with irritable bowel syndrome.
Comparison of the efficacy of schema therapy and mindfulness-based cognitive therapy on symptoms, anxiety sensitivity and sleep quality in patients with irritable bowel syndrome
Design
Clinical trial with control group, randomized, on 45 patients. Lottery
Settings and conduct
10 sessions of schema therapy were conducted at the research center for an experimental group of 15 people, and 10 sessions of mindfulness-based cognitive therapy were conducted at the research center for another experimental group of 15 people.
Participants/Inclusion and exclusion criteria
Diagnosis of irritable bowel syndrome based on Rome IV criteria with confirmation from a gastroenterologist
Lack of history of psychotherapy and lack of use of psychiatric medications
Intervention groups
intervention groups with schema therapy and mindfulness based on cognitive therapy and a waiting list control group
Comparison of the efficacy of schema therapy and mindfulness-based cognitive therapy on symptoms, anxiety sensitivity and sleep quality in patients with irritable bowel syndrome.
Public title
Comparison of the efficacy of schema therapy and mindfulness-based cognitive therapy on symptoms, anxiety sensitivity and sleep quality in patients with irritable bowel syndrome.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
patients with irritable bowel syndrome
Exclusion criteria:
History of psychotherapy
Taking psychiatric drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization - will be randomly assigned to intervention and control groups, and patients will be randomly assigned to three groups of 15 after meeting the entry criteria. The random selection method will be done by lottery and a number will be assigned to each of the sample people, and then the numbers will be randomly selected with the help of Excel software, which will form the test group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Najafaba Branch
Street address
no.8,homa alley,north towhid st
City
esfahan
Province
Isfehan
Postal code
8173655463
Approval date
2024-08-22, 1403/06/01
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1403.134
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
High score on the Irritable Bowel Symptom Severity Questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, and 3 months after the end of the intervention
Method of measurement
Francis et al. Irritable Bowel Syndrome Severity Questionnaire
2
Description
Revised Anxiety Sensitivity Inventory
Timepoint
Before the start of the intervention, after the end of the intervention, and 3 months after the end of the intervention
Method of measurement
Taylor and Cox's Revised Anxiety Sensitivity Inventory
3
Description
Score on the sleep quality questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention, and 3 months after the end of the intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 group schema therapy sessions of Jeffrey Young's schema therapy protocol every week for 90 minutes. The intervention was designed according to the principles of the cognitive-emotional model of schema therapy and included the identification and modification of early maladaptive schemas, activation of maladaptive coping styles, and enhancement of adaptive coping strategies using cognitive, emotional, experiential (e.g., empty-chair technique, guided imagery), behavioral, and interpersonal techniques.
Category
Treatment - Other
2
Description
Intervention group: 10 sessions of cognitive-based mindfulness group training each week for 90 minutes. The program included practices such as body scan, mindful breathing, mindful walking, thought meditation, and emotional acceptance. Sessions were conducted in groups and facilitated by a therapist trained in the MBCT approach. To enhance the effectiveness of the program, daily home practice (30 to 45 minutes per day) was also assigned to participants.
Category
Treatment - Other
3
Description
Control group: waiting list. After the completion of the study, participants in this group will be given the opportunity to take part in one of the intervention programs.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
alzahra hospital
Full name of responsible person
Maryam soheilipor
Street address
Alzahra hospital,sofeh st
City
esfahan
Province
Isfehan
Postal code
8173734441
Phone
+98 31 3261 4434
Email
maryamsoheilip@MEd.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar Jarib St, Esfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 3071
Email
Maryamsoheilip@MEd.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Bazargan
Position
PH.d.student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 8, homes Alley, North Towhid Street
City
Esfahan
Province
Isfehan
Postal code
8158987864
Phone
+98 31 3625 8583
Fax
Email
Miss.shaghayegh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Bazargan
Position
PH.d.student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 8, homes Alley, North Towhid Street
City
Esfahan
Province
Isfehan
Postal code
8158987864
Phone
+98 31 3625 8583
Fax
Email
Miss.shaghayegh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Bazargan
Position
PH.d.student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8, Homa Alley, North Towhid Street, Unit 10
City
Esfahan
Province
Isfehan
Postal code
8158987864
Phone
+98 31 3625 8583
Fax
Email
Miss.shaghayegh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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