Protocol summary

Summary
Objective: Current cultural and social standards emphasize at attractiveness and thinness. So, a main and worldwide problem among women is body dissatisfaction, which result in eliciting malproductive self- schemas. This can affect the interpersonal relationships, socio-emotional state, and perceived self- evaluation in young individuals. Therefore, this research was aimed to investigating the efficacy of behavioral-mindfulness and non- judgmental acceptance therapy on modifying negative body image, and self- schemas among girls in Tehran. Design: After announcing the trial on the boards of Tehran Payame Noor University, and applying convenience sampling method, Those who were volunteer for the trial, and their score in Multidimensional body- self relations questionnaire were less than 160, and They obtained scores in the subscale of Satisfaction with body areas less than 33 were invited for initial assessment and interviewing. Setting and conduct: After initial assessment 26 subjects who were eligible for inclusion and exclusion criteria were selected and randomly were assigned into experimental and control groups (each included 13 subjects). All participants filled out all the items of MBSRQ, and Appearance Schema Inventory (ASI) prior to and after the intervention. Participants including major eligibility criteria: Inclusion criteria were Female, Educational degree upper than diploma, scoring <160 in Multidimensional Body-Self Relations Questionnaire , scoring<33 in Body Area Satisfaction subscale and Exclusion criteria were any personality disorder (for example paranoid, antisocial,...), and psychological disorder (for example OCD, Bipolar,...) based on clinical interview. Intervention: Experimental group participants received 12 sessions for behavioral-mindfulness and non- judgmental acceptance therapy. The therapy sessions were included into introducing body image concept, the factors that influence the negative body image, definition of mindfulness, thinking errors correction, taking non-judgmental position about beliefs, mirror-countering, self-monitoring and homework assignments (adopted from Bell and Rushforth, 2008) that it is instructed in 12 sessions (70 minutes). Main outcome: Result revealed that primary outcome measures ( negative body image and self- schemas modifying after behavioral-mindfulness and non- judgmental acceptance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204123457N5
Registration date: 2013-04-29, 1392/02/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-04-29, 1392/02/09
Registrant information
Name
Masuod Janbozorgi
Name of organization / entity
Behavioral Science Research Center, Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 919 151 9526
Email address
psychjan@gmail.com
Recruitment status
Recruitment complete
Funding source
Behavioral Sciences Research Center in Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-04-30, 1390/02/10
Expected recruitment end date
2011-06-04, 1390/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An empircial trial of Behavioral , mindfulness - non-judgmental acceptance intervention on negative body image and self-schema among girl's students
Public title
Effect of Behavioral- Mindfulness intervention in negative body image
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female, Educational degree upper than diploma, scoring <160 in Multidimensional Body-Self Relations Questionnaire , scoring<33 in Body Area Satisfaction subscale Exclusion criteria: Any personality disorder (eg.paranoid, antisocial,...), and psychological disorder (eg.OCD, Bipolar,...) based on clinical interview and criteria of DSM IV , Any medical condition
Age
From 20 years old to 32 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After announcing the trial on the boards of Tehran Payame Noor University, and applying convenience sampling method, Those who were volunteer for the trial, and their score in Multidimensional body- self relations questionnaire were less than 160, and They obtained scores in the subscale of Satisfaction with body areas less than 33 were invited for initial assessment and interviewing. After initial assessment 26 subjects were eligible for include- exclude criteria were selected and randomly were assigned into experimental and control groups (each included 13 subjects)

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Behavioral Sciences Research Center , Shahid Beheshti University of Medical Sci
Street address
Fifth Floor, Department of Behavioral Sciences Research Center, Imam Hussein Hospital, St. Shahid Madani, Tehran
City
Tehran
Postal code
Approval date
2011-01-29, 1389/11/09
Ethics committee reference number
89-01-102-7181-4978

Health conditions studied

1

Description of health condition studied
Negative body image
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services

2

Description of health condition studied
Self-schema
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services

Primary outcomes

1

Description
Negative body image
Timepoint
Before intervention and after intervention (The last session of therapy)
Method of measurement
Multidimensional Body-Self Relations Questionnaire

2

Description
Self-schema
Timepoint
Before intervention and after intervention (The last session of therapy)
Method of measurement
Appearance Schema Inventory

Secondary outcomes

1

Description
Appearance evaluation
Timepoint
Before intervention and after intervention (The last session of therapy)
Method of measurement
Multidimensional Body-Self Relations Questionnaire

2

Description
Fitness evaluation
Timepoint
Before intervention and after intervention (The last session of therapy)
Method of measurement
Multidimensional Body-Self Relations Questionnaire

3

Description
Fitness orientation
Timepoint
Before intervention and after intervention (The last session of therapy)
Method of measurement
Multidimensional Body-Self Relations Questionnaire

4

Description
Body areas satisfaction
Timepoint
Before intervention and after intervention (The last session of therapy)
Method of measurement
Multidimensional Body-Self Relations Questionnaire

Intervention groups

1

Description
Behavioral- mindfulness - non-judgmental acceptance in intervention group . The therapy sessions were included into introducing body image concept, the factors that influence the negative body image, definition of mindfulness, thinking errors correction, taking non-judgmental position about beliefs, mirror-countering, self-monitoring and homework assignments(adopted from Bell and Rushforth, 2008) that it is instructed in 12 sessions (70 minutes)
Category
Behavior

2

Description
They had no treatment and were in waiting list
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Payame Noor University
Full name of responsible person
Mojgan Agahheris
Street address
St. Nejatollahi , Tehran Payame Noor University, Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Rahe Salamat Counseling Center
Full name of responsible person
Mojgan Agahheris
Street address
Unit 12, Third Floor, Negar Building, Negar Alley, South Ekhtiarieh intersection, St. Dolat , Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Alireza Zahiredin
Street address
Fifth Floor, Department of Behavioral Sciences Research Center, Imam Hossein Hospital, St. Shahid Madani , Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rahe Salamat Counseling Center
Full name of responsible person
Masoud Janbozorgi
Position
Associated professor
Other areas of specialty/work
Street address
Unit 12, Third Floor, Negar Building, Negar Alley, South Ekhtiarieh intersection, St. Dolat, Tehran
City
Tehran
Postal code
Phone
+98 21 2257 2274
Fax
Email
janbozorgi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rahe Salamat Counseling center
Full name of responsible person
Masoud Janbozorgi
Position
Associated professor
Other areas of specialty/work
Street address
Unit 12, Third Floor, Negar Building, Negar Alley, South Ekhtiarieh intersection, St. Dolat, Tehran
City
Tehran
Postal code
Phone
+98 21 2257 2274
Fax
Email
janbozorgi@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rahe Salamat Counseling Center
Full name of responsible person
Masoud Janbozorgi
Position
Associated professor
Other areas of specialty/work
Street address
Unit 12, Third Floor, Negar Building, Negar Alley, South Ekhtiarieh intersection, St. Dolat, Tehran
City
Tehran
Postal code
Phone
+98 21 2257 2274
Fax
Email
janbozorgi@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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