Comparison of the Effectiveness of Acceptance and Commitment Therapy, Schema Therapy and Life Therapy on Quality of life , Emotion Regulation , Eating Attitude and Rate of Adherence of Obese Women
The effectiveness of acceptance and commitment, schema therapy and life therapy on quality of life, emotion regulation, eating attitude and overall compliance in obese people.
Design
A clinical trial with a control group, with parallel groups, a blind strain, 60 obese women were selected by purposive sampling and randomly replaced in four groups.
Settings and conduct
Obese women referring to Rouhani Babol Hospital, those who have lower than average scores in the indicators of quality of life, emotional regulation and general compliance, 60 people will be selected by purposeful sampling and will be randomly replaced in four groups and three experimental groups. and a control group will be placed.
Participants/Inclusion and exclusion criteria
Age 18 to 50, at least a diploma education, being a volunteer to participate, having an axis two disorder or a severe mental problem, having a BMI score above 30 and being obese.
Intervention groups
Acceptance and commitment to life therapy schema therapy
Main outcome variables
Comparing the effectiveness of treatments on quality of life, emotion regulation, eating attitude and overall compliance in obese women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230426058004N1
Registration date:2023-05-01, 1402/02/11
Registration timing:prospective
Last update:2023-05-01, 1402/02/11
Update count:0
Registration date
2023-05-01, 1402/02/11
Registrant information
Name
Akram Mohammadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3238 4833
Email address
mohammadian_a77@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-07-06, 1402/04/15
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, Schema Therapy and Life Therapy on Quality of life , Emotion Regulation , Eating Attitude and Rate of Adherence of Obese Women
Public title
"Study of the effectiveness of psychological treatments on quality of life, emotion regulation, attitude to eating and overall compliance in women with obesity"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 50 years
Minimum education is diploma
Being a volunteer to participate in research
Not having axis two disorder or severe mental problem
Also, select people who have a score higher than 30 based on the BMI index and are obese. After selecting the samples, each of them will be randomly replaced in one of the groups
Not having a psychiatric illness other than health anxiety
Not suffering from a serious physical illness such as cancer, MS, Alzheimer's and the like
Completing the informed consent agreement to participate in the research project
Exclusion criteria:
Lack of consent to participate in the study
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, people, who are invited to participate in the study and are classified in intervention groups after obtaining informed consent. They are unaware of the existence of other intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sari Azad University
Street address
PO Box: 48164-48164، km 7 of Darya Road, Sari،Mazandaran Province,
City
Sari
Province
Mazandaran
Postal code
Approval date
2023-02-22, 1401/12/03
Ethics committee reference number
IR.IAU.SARI.REC.1401.250
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study (before the start of the intervention), at the end of the intervention period, a follow-up test is also performed after 3 months.
Method of measurement
Quality of Life Questionnaire (SF-36)
2
Description
Cognitive regulation of emotion
Timepoint
At the beginning of the study (before the start of the intervention), at the end of the intervention period, a follow-up test is also performed after 3 months.
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ)
3
Description
Attitude to eat
Timepoint
At the beginning of the study (before the start of the intervention), at the end of the intervention period, a follow-up test is also performed after 3 months.
Method of measurement
Garner and Garfinkel Eating Attitude Questionnaire (EAT-26)
4
Description
General compliance
Timepoint
At the beginning of the study (before the start of the intervention), at the end of the intervention period, a follow-up test is also performed after 3 months.
Method of measurement
General Adherence Scale (GAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Commitment and acceptance therapy
Category
Lifestyle
2
Description
Intervention group: Schema therapy
Category
Lifestyle
3
Description
Intervention group: life therapy
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Clinic of Ayatollah Rouhani Hospital
Full name of responsible person
Akram Mohammadian Amiry
Street address
next to University of Medical Sciences ، Ganj Afrooz Road ، Babol ، Mazandaran Province
City
babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8301
Fax
+98 11 3223 8309
Email
Ravabet_Mubabol@yahoo.com
Web page address
https://rohani.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Akram Mohammadian Amiry
Street address
Ayatollah Rouhani educational and therapeutic center ، Ganj Afrooz Street ، Baol
City
Baol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8300
Fax
+98 11 3223 8309
Email
Ravabet_Mubabol@yahoo.com
Web page address
https://rohani.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Akram Mohammadian Amiry
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Arghvan town , next to Mazi Noor, Amirkola to Babolsar road,Mazandaran
City
Babol
Province
Mazandaran
Postal code
4745111149
Phone
+98 11 3238 4833
Email
Mohammadian_a77@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Mohammadian Amiry
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Arghvan town، next to Mazi NoorAmirkola to Babolsar road,Mazandaran,
City
Babol
Province
Mazandaran
Postal code
4745111149
Phone
+98 11 3238 4833
Email
Mohammadian_a77@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Mohammadian Amiry
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Arghvan town, next to Mazi Noor, Amirkola to Babolsar road , Mazandaran
City
Babol
Province
Mazandaran
Postal code
4745111149
Phone
+98 11 3238 4833
Email
Mohammadian_a77@yahoo.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
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The protocol of all three treatments, questionnaires
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions will be available
Under which criteria data/document could be used
No idea
From where data/document is obtainable
Mohammadian_a77@yahoo.com
What processes are involved for a request to access data/document