Protocol summary

Summary
The purpose of this study was to examine effectiveness of acceptance and commitment therapy on body dissatisfactiony؛ obsessions-compulsions and fear of negative evaluation in highschool girls adolescents with body dysmorphic disorder. The present study was administered with a experimental design with pre-test, post-test and control group. Statistical society included all of highschool girls students with body dysmorphic disorder of Najafabad city that among them 30 persons selected by rondom multistage sampling and divided to one experimental (N=15) and one control (N=15) group. 8 session (each of them was 1.5 houres) performed for experimental group while control group received no intervention. Structured Clinical Interview for DSM IV (SCID-I), body dissatisfaction questionnaire, and fear of negative evaluation questionnaire used as the instruments of the study in pre-test and post test stages for two groups.The criteria for inclusion were body dysmorphic disorder diagnosis as the main diagnosis, lack of comorbidity with other psychological disorders, age range of 14-17 years, and studying in a high-school. The criteria for exclusion from the present research were beginning medical treatment, being absent for three sessions, and not following group rules.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101324521N1
Registration date: 2015-11-16, 1394/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-11-16, 1394/08/25
Registrant information
Name
Azam Habibollahi
Name of organization / entity
Islamic Azad University, Najafabad
Country
Iran (Islamic Republic of)
Phone
+98 31 4251 0248
Email address
az.h888@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Azad University, Najaf Abad
Expected recruitment start date
2014-01-10, 1392/10/20
Expected recruitment end date
2014-04-19, 1393/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy on body dissatisfaction؛ obsessions-compulsions and fear of negative evaluation in girl adolescents with body dysmorphic disorder
Public title
The effectiveness of acceptance and commitment therapy(ACT) on body dysmorphic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
The criteria for inclusion were body dysmorphic disorder diagnosis as the main diagnosis, lack of comorbidity with other psychological disorders, age range of 14-17 years, and studying in a high-school. The criteria for exclusion from the present research were beginning medical treatment, being absent for three sessions, and not following group rules.
Age
From 14 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
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 Islamic Azad University, Najafabad
Street address
Pouryaye Vali Blvd, Islamic Azad University, Najafabad
City
Najafabad
Postal code
Approval date
2014-03-11, 1392/12/20
Ethics committee reference number
15020701922003

Health conditions studied

1

Description of health condition studied
body dysmorphic disorder
ICD-10 code
F45.2
ICD-10 code description
Hypochondriacal disorder

Primary outcomes

1

Description
body dissatisfaction
Timepoint
Before intervention-After intervention
Method of measurement
Body Image Concern Inventory

2

Description
obsessions-compulsions
Timepoint
Before intervention-After intervention
Method of measurement
Yale-Brown obsessive compulsive scale for BDD

3

Description
fear of negative evaluation
Timepoint
Before intervention-After intervention
Method of measurement
Brief Fear of Negative Evaluation Scale

Secondary outcomes

empty

Intervention groups

1

Description
Acceptance and commitment therapy is among therapies of the third wave of behavior therapies and was introduced in early 1980s by Hayes and his colleagues. Then acceptance and commitment therapy intervention sessions were undertaken in the form of eight weekly group sessions, one hour and a half each, for the experimental group. Based on acceptance and commitment therapy sessions are,First Session:introducing fundamentals of therapy.second session:creative helplessness.Third session:control is the question.fourth Session:acceptance as a substitute for avoidance.Fifth session:defusion.Sixth Session:self as context and being present.Seventh session:values.Eighth session:commitment to action
Category
Behavior

2

Description
The control group received no intervention
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahidan kamali High School
Full name of responsible person
Azam Habibollahi
Street address
Yazdanshahr, Najafabad, Esfahan
City
Yazdanshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Azad University of Najaf Abad
Full name of responsible person
Dr Reza Ebrahimi
Street address
Pouryaye Vali Blvd, Azad University of Najafabad, Najafabad
City
Najafabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Azad University of Najaf Abad
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
Islamic Azad University, Najafabad
Full name of responsible person
Azam Habibollahi
Position
Master of Science
Other areas of specialty/work
Street address
Pouryaye Vali Blvd, Islamic Azad University, Najafabad
City
Najafabad
Postal code
Iran
Phone
+98 31 4251 0248
Fax
Email
Az.h888@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Najafabad
Full name of responsible person
Mohammad Soltanizadeh
Position
PHD
Other areas of specialty/work
Street address
Pouryaye Vali Blvd, Islamic Azad University, Najafabad
City
Najafabad
Postal code
Phone
+98 31 3234 5717
Fax
Email
mohammad.soltani@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Najafabad
Full name of responsible person
Azam Habibollahi
Position
Master of Science
Other areas of specialty/work
Street address
Pouryaye Vali Blvd, Islamic Azad University, Najafabad
City
Najafabad
Postal code
Phone
+98 31 4251 0248
Fax
Email
Az.h888@yahoo.com
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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