Protocol summary

Study aim
The aim of the present study is to determine the effectiveness of paradox therapy on anxiety, rumination, and ego strength in adolescents with body dysmorphic symptoms.
Design
Control and experimental groups, pre-test, post-test and follow-up, were randomized, on 40 patients (20 in each group). Data analysis was performed using MANCOVA multivariate analysis of covariance in SPSS software.
Settings and conduct
Sediqeh Kobri High School located in Region 4 was selected through random sampling, purposive sampling to identify students who had complaints of body dysmorphic disorder, identified using the modified Yale-Brown Obsessive Compulsive Scale for Body Dysmorphic Disorder (YBOCS-BDD), (Phillips et al., 1997),They will be randomly assigned to two experimental and control groups, each group consisting of 20 people. In total, 40 students will participate in this study. Post-test, post-test, and follow-up.
Participants/Inclusion and exclusion criteria
Teenage girls from Sediqeh Kobri High School,Having symptoms of body dysmorphic disorder according to DSM5TR, adolescent age between 13 and 18 years, voluntary consent to participate in research and treatment.Exclusion criteria: Severe psychological disorders and a history of medication use and psychiatric hospitalization, severe congenital or non-congenital physical defects that are visibly visible, addiction to any stimulant or addictive substance, failure to cooperate in completing the questionnaires or failure to answer questions.
Intervention groups
20 test subjects will be treated with PTC and will have to complete the tasks for 10 minutes once every ten days, 20 control subjects will not receive the intervention and will finally be compared to this group.
Main outcome variables
Anxiety; Rumination; Ego strength; Signs of body dysmorphic disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251004067501N1
Registration date: 2025-10-25, 1404/08/03
Registration timing: prospective

Last update: 2025-10-25, 1404/08/03
Update count: 0
Registration date
2025-10-25, 1404/08/03
Registrant information
Name
Atena Fadaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7700 2062
Email address
atenafadaee79@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-30, 1404/08/08
Expected recruitment end date
2025-11-15, 1404/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of paradox therapy on satisfaction, rumination, and ego strength in adolescents with body dysmorphic symptoms.
Public title
The effect of paradox therapy on anxiety, rumination, and ego strength in adolescents with body dysmorphic symptoms.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms of body dysmorphic disorder according to DSM5_TR. Adolescent age between 13 and 18 years. Voluntary consent to participate in research and treatment.
Exclusion criteria:
Having severe psychological disorders and a history of medication use and psychiatric hospitalization. The presence of severe congenital or non-congenital physical defects that are visibly visible. Addiction to any stimulant or addictive substance.
Age
From 13 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, District 4 was randomly selected from among 22 districts of Tehran. There are approximately 62 girls' high schools in District 4, and among these schools, Sedighe Kobri Girls' High School was randomly selected through a lottery. In this high school, students who have complaints of body deformity are identified using voluntary samples.They will be randomly assigned to two experimental and control groups through a lottery, so that each group will consist of 20 people. In total, 40 students will participate in this research.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, District 4 was randomly selected from among 22 districts of Tehran. There are approximately 62 girls' high schools in District 4, and among these schools, Sedighe Kobri Girls' High School was randomly selected. In this high school, students who have complaints of body deformity will be identified using purposive sampling.The Yale-Brown Obsessive Compulsive Scale for Body Dysmorphic Disorder (YBOCS-BDD) (Phillips et al., 1997) is used to assess these students. Students diagnosed with body dysmorphic disorder symptoms will be randomly assigned to two experimental and control groups, each group consisting of 20 students.A total of 40 students will participate in this study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran Azad University of Medical Sciences
Street address
No. 16 West, Headquarters Building of Islamic Azad University of Medical Sciences, West Gol-Yakh Street, Shahid Paborja Street, Shariati Street, Ayeneh Boulevard, Qolhak Crossroads
City
Tehran
Province
Tehran
Postal code
۱۹۴۹۶۳۵۸۸۱
Approval date
2025-05-24, 1404/03/03
Ethics committee reference number
IR.IAU.TMU.REC.1404.196

Health conditions studied

1

Description of health condition studied
Body dysmorphic disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
A score obtained from the modified Yale-Brown Obsessive Compulsive Disorder Inventory to prevent body deformity.
Timepoint
Before the intervention, after the intervention, and two months after the intervention
Method of measurement
Revised Yale-Brown Obsessive Compulsive Disorder Scale

2

Description
Anxiety score in the Depression, Anxiety, and Stress Scale(DASS21)
Timepoint
Before the intervention, after the intervention, and two months after the intervention
Method of measurement
Depression, Anxiety, and Stress Assessment Questionnaire DASS21

3

Description
Rumination score on the Nalen Hoeksma and Maru Rumination Questionnaire (RSQ)
Timepoint
Before the intervention, after the intervention, and two months after the intervention
Method of measurement
Nalen Hoeksma and Maru Rumination Questionnaire (RSQ)

4

Description
Ego Strength Score in Dr. Besharat's Ego Strength Questionnaire (ESS)
Timepoint
Before the intervention, after the intervention, and two months after the intervention
Method of measurement
Dr. Besharat's Ego Strength Questionnaire (ESS)

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group:Includes 20 female high school students who have body dysmorphic disorder but are not receiving any intervention.
Category
Other

2

Description
Intervention group: The first intervention group consists of 20 high school female students with body dysmorphic disorder who will undergo paradoxical therapy protocol treatment for one month, 6 sessions, Once every ten days,approximately 3 months. 20 people in the experimental group will receive treatment.Each session will take about 30 to 20 minutes, and each assignment will take about 10 minutes. The first session is a history and assignment, and the subsequent sessions are progress reports and new assignments. Paradox Therapy (PTC) is one of the new and innovative treatments that was introduced, invented, and implemented by Dr. Basharat.This technique includes two techniques: paradox and schedule. Paradox means prescribing the same behavioral cue, and schedule means performing prescribed tasks at specific times.Paradox therapy is a method that, by prescribing the client's own disturbing behaviors or symptoms, changes contradictory and damaging psychological patterns within a specified time frame, and improves the mental state and social relationships of adolescents.Paradox therapy is an individual technique in which the therapist asks the client to visualize their anxiety, rumination, stress, anger, hatred, and weaknesses at certain predetermined times for at least ten minutes in order to make them feel as bad as possible.This short-term treatment method is ethical, cost-effective, non-invasive, and produces profound and lasting changes without relapse. In this treatment protocol, the client kills two birds with one stone because both his problem is quickly reconstructed and solved through the performance of prescribed exercises (prescription) at predetermined times (artificialization) and he becomes the therapist.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sediqeh Kobri High School
Full name of responsible person
Afsaneh Safaviye
Street address
Farvardin St., Arbahar Boulevard, Phase 2, Hakimieh.
City
Tehran
Province
Tehran
Postal code
1659927583
Phone
+98 21 7730 7779
Email
sedighemadrese77@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Khoshdel
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences, Dr. Shariati St., Qolhek intersection, Amir Paborja St., Aineh Blvd., corner of Gol Yakh St.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2200 6660
Email
iuc@iautmu.ac.ir
Web page address
https://tms.iau.ir/iuc/fa
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
Atena Fadaee
Position
collegian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Block 43, Besharat Street, Phase 2, Imam Hussein University Alley, Hakimieh,
City
Tehran
Province
Tehran
Postal code
1659756553
Phone
+98 21 7700 2062
Email
atenafadaee79@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atena Fadaee
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit1, Floor 1, Block 43, Besharat Street, Phase 2 of Imam Hussein University Quarter, Hakimieh
City
Tehran
Province
Tehran
Postal code
1659756553
Phone
+98 21 7700 2062
Fax
Email
atenafadaee79@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atena Fadaee
Position
collegian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Block 43, Besharat Street, Phase 2, Imam Hussein University Alley, Hakimieh,
City
Tehran
Province
Tehran
Postal code
1659756553
Phone
+98 21 7700 2062
Email
atenafadaee79@gmail.com

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
Data obtained from the intervention can be shared after de-identifying individuals.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
The data will be available to both researchers working in academic and scientific institutions and people working in industry.
Under which criteria data/document could be used
Use in prospective research that helps maintain adolescent mental health.
From where data/document is obtainable
Applicants can send a message to the email address: atenafadae79@gmail.com, in the name of Atena Fadaei.
What processes are involved for a request to access data/document
After sending a message to the mentioned email, the documents will be sent to the applicants.
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