Comparison of self-efficacy theory and self-compassion therapy on depression, self-care behaviors and quality of life of patients with irritable bowel syndrome
Comparison of the effectiveness of self-efficacy theory training and compassion-focused therapy on depression, self-care behaviors and quality of life in patients with irritable bowel syndrome
Design
A randomized controlled clinical trial with parallel groups, without blinding
Settings and conduct
The statistical population includes all patients with irritable bowel syndrome referred to Khorshid hospital in Isfahan. The study sample consisted of 45 patients with irritable bowel syndrome who were randomly divided into two equal intervention groups and one control group. The sampling method in this study is purposive. The intervention duration will be 6 months and the intervention group will be randomly divided into two groups of 15 each. Patients in all three groups will receive routine treatment of gastrointestinal irritable bowel syndrome, but the intervention group will undergo self-efficacy and compassion-focused therapy programs designed in an executive protocol in addition to routine treatment. It took.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of irritable bowel syndrome based on Rome II criteria was diagnosed by a gastroenterologist with no psychiatric treatment during the past three months.
Exclusion criteria: Symptoms such as gastrointestinal bleeding, fecal hemorrhage, fever, 1% weight loss in the past 6 months, family history of colon cancer, severe psychiatric illness, and first-degree relatives or they were neighbors.
Intervention groups
For the first group of Self-efficacy theory training, For the second group Compassion-focused treatment and inthe third group, no intervention will be performed.
Main outcome variables
Depression, self-care behaviors, and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191217045761N1
Registration date:2020-02-08, 1398/11/19
Registration timing:retrospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Fakhrialsadat Khalifesoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3337 5332
Email address
psrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-15, 1398/05/24
Expected recruitment end date
2020-01-08, 1398/10/18
Actual recruitment start date
2019-08-15, 1398/05/24
Actual recruitment end date
2020-01-08, 1398/10/18
Trial completion date
2020-01-08, 1398/10/18
Scientific title
Comparison of self-efficacy theory and self-compassion therapy on depression, self-care behaviors and quality of life of patients with irritable bowel syndrome
Public title
Comparison of self-efficacy theory and self-compassion therapy on depression, self-care behaviors and quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of irritable bowel syndrome based on Rome II criteria with diagnosis of gastroenterologist
no psychiatric treatment for the past three months
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
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
Ethics committee of Hormozgan University of Medical Sciences (HUMS)
Street address
Sana Complex, No. 1, Kashani St., Isfahan.
City
Hormozgan
Province
Hormozgan
Postal code
3259874168
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.311
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
Deppression
Timepoint
At the beginning of the study (before the intervention), and one and a half months after the intervention
Method of measurement
Beck Depression Inventory
2
Description
Self-care
Timepoint
At the beginning of the study (before the intervention), and one and a half months after the intervention
Method of measurement
Self-Care Questionnaire Alizadeh et al. (2016)
3
Description
Quality of Life
Timepoint
At the beginning of the study (before the intervention), and one and a half months after the intervention
Method of measurement
Ware & Sherbourne Quality of Life Questionnaire (1996)
Secondary outcomes
empty
Intervention groups
1
Description
Self-efficacy theory training
Category
Treatment - Other
2
Description
Compassion-focused treatment
Category
Treatment - Other
3
Description
Control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Amin Rafiepour
Street address
Noor Medical Center, Ostandari St.
City
Isfahan
Province
Isfehan
Postal code
8183693311
Phone
+98 31 3224 0970
Email
bsrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Islamic Azad University of Kish International Branch, Free Zone Organization Square, Sana'i Boulevard, Kish Island.
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
Info@IaukishInt.Ac.Ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
20
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
Fakhrialsadat Khalifesoltani
Position
Reasearch expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No8, Sana building, Kashani st.
City
Isfahan
Province
Isfehan
Postal code
8183693311
Phone
+98 31 3337 5332
Email
Psrc@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fakhrialsadat Khalifesoltani
Position
Reasearch expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No8, Sana building, Kashani st.
City
Isfahan
Province
Isfehan
Postal code
8183693311
Phone
+98 31 3337 5332
Fax
Email
Psrc@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fakhrialsadat Khalifesoltani
Position
Reasearch expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No8, Sana building, Kashani st.
City
Isfahan
Province
Isfehan
Postal code
8183693311
Phone
+98 31 3337 5332
Fax
Email
Psrc@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any statistical analysis of the data is permitted.