Designing and developing a treatment model to reduce body deformity disorder in women
Design
Clinical trial without control group, on 3 patients
Settings and conduct
In this research, A-B-A design was used along with a multiple baseline, carried out at Ferdowsi University of Mashhad
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being women; Body dysmorphic disorder;
Age between 20 and 50 years old.
Non-inclusion criteria: Intellectual disability
Intervention groups
The therapy is a combination of ACT techniques, schema therapy, and mindfulness. The intervention is arranged and presented in 16 sessions: 1.Preparation for starting the treatment 2. Preparation of the treatment context to pass from the mechanical state to conscious3. Preparing the treatment context for acceptance 4. Constructive despair - creating a space for new solutions 5. Attention to awareness, acceptance, goals and values
Main outcome variables
Body Dysmorphic Disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220730055583N1
Registration date:2023-02-09, 1401/11/20
Registration timing:retrospective
Last update:2023-02-09, 1401/11/20
Update count:0
Registration date
2023-02-09, 1401/11/20
Registrant information
Name
ali azamrajabian
Name of organization / entity
Ferdowsi university of mashhad
Country
Iran (Islamic Republic of)
Phone
+98 915 797 0967
Email address
ali.azamrajabian@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and developing a treatment model to prevent body deformity in women
Public title
The effect of combined treatment to reduce body dysmorphic disorder in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being women
Body dysmorphic disorder
Age between 20 and 50 years old
Exclusion criteria:
Intellectual disability
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ferdowsi University of Mashhad
Street address
Ferdowsi University of Mashhad; Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Approval date
2022-08-21, 1401/05/30
Ethics committee reference number
IR.UM.REC.1401.105
Health conditions studied
1
Description of health condition studied
Body dysmorphic disorder
ICD-10 code
F45.22
ICD-10 code description
Body dysmorphic disorder
Primary outcomes
1
Description
Body deformity disorder
Timepoint
At the beginning of the study and 3, 6, 9, 13 and 16 weeks after the start of the treatment
Method of measurement
content analysis
Secondary outcomes
empty
Intervention groups
1
Description
The therapy is a combination of ACT techniques, schema therapy, and mindfulness. The intervention is arranged and presented in 16 sessions: 1.Preparation for starting the treatment 2. Preparation of the treatment context to pass from the mechanical state to conscious3. Preparing the treatment context for acceptance 4. Constructive despair - creating a space for new solutions 5. Attention to awareness, acceptance, goals and values
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad
Full name of responsible person
Mohammad Javad Asghari ebrahimabad
Street address
Ferdowsi University of Mashhad; Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 2000
Email
mjasghari@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research and Technology of Ferdowsi University of Mashhad Ferdowsi
Full name of responsible person
Reza Lotfi
Street address
Ferdowsi University of Mashhad; Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 2000
Email
pr@um.ac.dot.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research and Technology of Ferdowsi University of Mashhad Ferdowsi
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
Ferdowsi University of Mashhad
Full name of responsible person
Ali Azam Rajabian
Position
STUDENT
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 33; Emam Reza 35 street
City
Mashhad
Province
Razavi Khorasan
Postal code
9173775865
Phone
+98 903 488 1248
Email
ali.azamrajabian@mail.um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Ali Azam Rajabian
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 33; Emam Reza 35 street
City
Mashhad
Province
Razavi Khorasan
Postal code
9173775865
Phone
+98 903 488 1248
Email
ali.azamrajabian@mail.um.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Ali Azamrajabian
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 4; No 33; Emam Reza 35 street
City
mashhad
Province
Razavi Khorasan
Postal code
9173775865
Phone
+98 915 797 0967
Fax
Email
ali.azamrajabian@mail.um.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts from 2023
To whom data/document is available
People who are also engaged in the industry can apply to receive them.
Under which criteria data/document could be used
For practical use
From where data/document is obtainable
ail.azamrajabian@mail.um.ac.ir
علی اعظم رجبیان
What processes are involved for a request to access data/document
The treatment is being implemented and after the final evaluation of the initial questionnaires that were collected from the patients in December 1401, the post-test results will be obtained by May 30.