Efficacy of Transdiagnostic therapy on psychological variables and reduce symptoms in Adolescents with sub-clinical symptoms of body dismorphic disorder
Effectiveness of transdiagnostic cognitive-behavioral therapy in cognitive, social, emotional variables and reducing symptoms in adolescents with preclinical symptoms of body deformity disorder
Design
The clinical trial, with a waiting list group, is one-sided blind and a sample size of 62 people will be selected and they will be placed in two intervention and waiting list groups based on the assignment of random blocks. Triple evaluations will be done by one of the research colleagues, and the therapist will not participate in the data analysis.
Settings and conduct
Sampling, evaluation and treatment will be done in Beheshti Hospital. The samples will be placed in two intervention and waiting list groups based on random block assignment. Therapists and participants will be blinded to group allocation and assessment information.
Participants/Inclusion and exclusion criteria
Inclusion
Having symptoms of body deformity disorder at the preclinical level
Age range between 12-18 years
Interest of the participants to participate in the research
Exclusion
Having severe psychiatric disorders
Drug and alcohol consumption in the last three months
Receiving cognitive-behavioral interventions
receiving drug therapy within a month before starting the intervention
Having a chronic medical disease
Receiving another similar psychological intervention
Intervention groups
The intervention group will receive UP extradiagnostic treatment. This protocol has 8 modalities that focus on cognitive restructuring, exposure to physical symptoms, exposure and response inhibition, and emotion regulation. The number of sessions is 12-18 sessions.
Main outcome variables
Social adjustment
Physical deformity
Inconsistent self-focused attention
depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210428051113N2
Registration date:2023-03-16, 1401/12/25
Registration timing:prospective
Last update:2023-03-16, 1401/12/25
Update count:0
Registration date
2023-03-16, 1401/12/25
Registrant information
Name
vahideh javadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3372 5349
Email address
vjavadi76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Transdiagnostic therapy on psychological variables and reduce symptoms in Adolescents with sub-clinical symptoms of body dismorphic disorder
Public title
Efficacy of Transdiagnostic therapy in Adolescents with sub-clinical symptoms of body dismorphic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms of body dismorphic disorder at the preclinical level
Age range between 12-18 years
Interest of the participants to participate in the research based on written consent
Exclusion criteria:
Having severe psychiatric disorders (psychotic spectrum, bipolar disorder)
Drug and alcohol consumption in the last three months
Receiving cognitive-behavioral interventions in the last 5 years
receiving drug therapy within a month before starting the intervention
Having a chronic medical disease
Receiving another similar psychological intervention at the same time as the current research
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In order to have an equal number of participants in the intervention and control groups at consecutive but equal time intervals, two blocks will be considered and the samples will be placed in the two intervention groups and the waiting list based on the assignment of random blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done in connection with the therapist regarding the allocation of people in the treatment groups and waiting list, as well as evaluation and evaluation information of three stages.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Arg gate, Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4514147814
Approval date
2023-01-17, 1401/10/27
Ethics committee reference number
IR.ZUMS.REC.1401.312
Health conditions studied
1
Description of health condition studied
body dysmorphic disorder
ICD-10 code
F45.2
ICD-10 code description
Hypochondriacal disorders
Primary outcomes
1
Description
social adjustment
Timepoint
before the intervention, after the intervention and three months after the intervention
Method of measurement
The score a person gets from Bell's social adjustment test.
2
Description
body dismorphic
Timepoint
before the intervention, after the intervention and three months after the intervention
Method of measurement
The score a person gets in the body deformity concern questionnaire (DCQ).
3
Description
Negative self-focused attention
Timepoint
before the intervention, after the intervention and three months after the intervention
Method of measurement
The score that a person gets in the focus of attention questionnaire (FAQ).
4
Description
Depression
Timepoint
before the intervention, after the intervention and three months after the intervention
Method of measurement
The score that a person gets from the Hamilton questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive integrated metadiagnostic treatment. This treatment has 8 modalities and is performed in 8-12 sessions. The duration of each session is 45 minutes. The content of therapeutic modalities includes emotional awareness, cognitive restructuring, exposure to physical symptoms, exposure and inhibition of response, and parental modality, which focuses on teaching maladaptive educational behaviors and their alternatives. And protocol training forms and worksheets are also given to clients at the end of the sessions.
Category
Treatment - Other
2
Description
Control group: A waiting list group that does not receive extradiagnostic treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Seyedeh Elnaz Mousavi
Street address
Gate of Beheshti Hospital citadel
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
Elnaz48.mousavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahdi Babamoradi
Street address
Karmandan ,Mahdavi Street, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3301 8624
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
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
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Elnaz Mousavi
Position
Faculty of Zanjan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
َArg Gate Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3356 2603
Email
elnaz48.mousavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seysdeh Elnaz Mousavi
Position
Faculty of Zanjan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Arg Gate Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4514147814
Phone
0244513615788
Email
elnaz48.mousavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vahideh Javadi
Position
psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Arg Gate Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4514147814
Phone
+98 24 3372 5349
Email
vjavadi76@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
To maintain the confidentiality of client information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
The information obtained from the evaluations and the results of the questionnaire and interview tools will be used for data analysis.
When the data will become available and for how long
7 months after the publication of the results
To whom data/document is available
Health researchers in academic and scientific institutions
Under which criteria data/document could be used
Information will be provided to researchers under conditions of confidentiality and in order to advance research in the field of meta-diagnostic treatment and complete the history of this treatment.
From where data/document is obtainable
Correspond author and colleagues of this research
What processes are involved for a request to access data/document
Communicating with the responsible author and requesting permission in writing and having permission to receive data for access