Protocol summary

Study aim
The effectiveness of Cognitive Hypnotherapy on the Coping self-efficacy, Executive functions، Cognitive Emotional Regulation, Mental health, Food Craving and weight loss of Women with Obesity
Design
Clinical study with intervention and control groups, quasi-experimental with pre-test, post-test design, purposive sampling and assigning to intervention and control groups non-randomly.
Settings and conduct
The statistical population of this study is women with obesity referring to large Oil Hospital of Ahvaz in 1399. The present study is done through purposive sampling method. Based on this method, first the application form for announcing voluntary participation in medical centers is administered among the statistical population and 30 women with obesity are chosen through purposive sampling method and then they are assigned to intervention and control groups, each group consisting of 15. Subjects of intervention group will be trained. Control group: This group receives no instruction. Then the questionnaires are administered among the subjects and the data are analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female Body mass index equals to or greater than 30 kg / m2 Age between 20 to 50 years old Able to be hypnotized Education diploma and higher Not being pregnant and not having a pregnancy plan Not participating in any other psychological treatment Exclusion criteria: Suffering from intensive neurological and mental disease Being addictive to drugs such as psychedelics and stimulants
Intervention groups
Intervention group: The participants receive 12 sessions of cognitive hypnotherapy training including cognitive therapy training (IPOM) and hypnotherapy.Control group: This group receives no training.
Main outcome variables
Coping self-efficacy, Executive functions, Cognitive Emotional Regulation, Mental health, Food Craving, weight loss

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200622047889N1
Registration date: 2020-09-19, 1399/06/29
Registration timing: prospective

Last update: 2020-09-19, 1399/06/29
Update count: 0
Registration date
2020-09-19, 1399/06/29
Registrant information
Name
Maryam Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3445 6155
Email address
oranoos8710@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive Hypnotherapy on the coping self-efficacy, executive functions, Cognitive Emotional Regulation, mental health, Food Craving and weight loss of Women with Obesity.
Public title
The effectiveness of cognitive Hypnotherapy on the coping self-efficacy, executive functions, Cognitive Emotional Regulation, mental health, Food Craving and weight loss of Women with Obesity.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index equals to or greater than 30 kg / m2 Age between 20 to 50 years old Able to be hypnotized Education diploma and higher Not being pregnant and not having a pregnancy plan Not participating in any other psychological treatment
Exclusion criteria:
Suffering from intensive neurological and mental disease Taking psychotropic or weight effective medicines
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 azad University of ahvaz
Street address
Ahvaz - Golestan Highway – Farhang-e-shahr Street - Islamic Azad University, Ahvaz Branch
City
Ahvaz
Province
Khouzestan
Postal code
61349-373336
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.IAU.AHVAZ.REC.1399.028

Health conditions studied

1

Description of health condition studied
Coping self-efficacy
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Executive functions
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Cognitive Emotional Regulation
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Mental health
ICD-10 code
ICD-10 code description

5

Description of health condition studied
Food Craving
ICD-10 code
ICD-10 code description

6

Description of health condition studied
Weight loss
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Coping self-efficacy
Timepoint
Before and after the intervention
Method of measurement
The Coping Self-Efficacy Scale (CES)

2

Description
Executive functions
Timepoint
Before and after the intervention
Method of measurement
Delis-Kaplan Executive Function System (D-KEFS)

3

Description
Cognitive Emotional Regulation
Timepoint
Before and after the intervention
Method of measurement
Cognitive Emotional Regulation Questionnaire (CERQ)

4

Description
Mental health
Timepoint
Before and after the intervention
Method of measurement
General Health Questionaire (G.H.Q)

5

Description
Food Craving
Timepoint
Before and after the intervention
Method of measurement
Food Craving Questionnaire-Trait: FCQ-T

6

Description
weight loss
Timepoint
Before and after the intervention
Method of measurement
digital scale

Secondary outcomes

empty

Intervention groups

1

Description
The statistical population of this study is women with obesity referring to large Oil Hospital of Ahvaz in 2020. In order to collect information, a statistical sample was chosen. The present study is done through purposive sampling method. Based on this method, first the application form for announcing voluntary participation in medical centers is administered among the statistical population and 30 women with obesity are chosen through purposive sampling method and then they are assigned to intervention and control groups, each group consisting of 15. Subjects of intervention group will be trained. Control group: This group receives no instruction. Then the questionnaires are administered among the subjects and the data are analyzed.
Category
Behavior

2

Description
Control group: This group receives no instruction.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Grand Oil Hospital
Full name of responsible person
Maryam Rostami
Street address
Iran. Ahvaz. Oil Town. Grand Oil Hospital
City
Ahvaz
Province
Khouzestan
Postal code
986134436601
Phone
+98 61 3443 6601
Email
director.ahv@piho.org
Web page address
https://www.piho.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ashkan Ghafouri
Street address
Ahvaz - Golestan Highway – Farhang-e-shahr Street - Islamic Azad University, Ahvaz Branch
City
Ahvaz
Province
Khouzestan
Postal code
1915
Phone
+98 61 3334 8421
Fax
+98 61 3332 9200
Email
info@iauahvaz.ac.ir
Web page address
http://iauahvaz.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
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
Maryam Rostami
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ahvaz - Golestan Highway – Farhang-e-shahr Street - Islamic Azad University, Ahvaz Branch
City
Ahvaz
Province
Khouzestan
Postal code
1915
Phone
+98 61 3334 8421
Fax
Email
rostami.maryam83@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Rostami
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ahvaz - Golestan Highway – Farhang-e-shahr Street - Islamic Azad University, Ahvaz Branch
City
Ahvaz
Province
Khouzestan
Postal code
1915
Phone
+98 61 3334 8421
Fax
Email
rostami.maryam83@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Rostami
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ahvaz - Golestan Highway – Farhang-e-shahr Street - Islamic Azad University, Ahvaz Branch
City
Ahvaz
Province
Khouzestan
Postal code
1915
Phone
+98 61 3334 8421
Fax
Email
rostami.maryam83@gmail.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
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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