The effectiveness of unified transdiagnostic treatment on emotional, cognitive, and neuropsychological symptoms and indicators in individuals with body dysmorphic disorder comorbid with emotional disorders: A clinical trial study
The present study aims to investigate the effectiveness of unified transdiagnostic treatment on emotional, cognitive, and neuropsychological symptoms and indicators in individuals with body dysmorphic disorder (BDD) comorbid with emotional disorders in a clinical trial study.
Design
34 participants suffering from BDD with comorbid emotional disorders will be randomized (using the Permuted block randomization method) and blinded in both treatment and control groups.
Settings and conduct
Allocation of participants will be administered by someone other than a therapist. For the allocation of the participants, a Permuted block randomization method will be used. Referrals for the treatment and wait-list groups will be from the counseling center of the University of Kurdistan and mental health professionals.
Participants/Inclusion and exclusion criteria
The study population will include people with body dysmorphic disorder (BDD) and comorbid emotional disorders in Sanandaj in 2023-2024. The sample of research also will include some people with BDD with comorbid emotional disorders.
Intervention groups
The individuals suffering from body dysmorphic disorder (BDD) with comorbid emotional disorders will randomly be assigned to two groups including UP and wait-list.
Main outcome variables
Body dysmorphic disorder; depression and Anxiety; difficulties in emotion regulation; anxiety sensitivity; cognitive emotion regulation; cognitive fusion; cognitive avoidance; inhibition; working memory; Problem-solving.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231001059577N1
Registration date:2024-01-18, 1402/10/28
Registration timing:prospective
Last update:2024-01-18, 1402/10/28
Update count:0
Registration date
2024-01-18, 1402/10/28
Registrant information
Name
Fateme Etaati
Name of organization / entity
The University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 21 5591 5918
Email address
fateme.etaati@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-25, 1402/11/05
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of unified transdiagnostic treatment on emotional, cognitive, and neuropsychological symptoms and indicators in individuals with body dysmorphic disorder comorbid with emotional disorders: A clinical trial study
Public title
The effectiveness of unified transdiagnostic treatment on body dysmorphic disorder comorbid with emotional disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of BDD disorder according to DSM-5
Having a minimum score of 53 in the body image concern inventory of Littleton et al
The presence of at least one emotional disorder
Age range of people from 18 to 45 years
Willing to participate in the study by signing a written consent form
The ability to speak Persian in all assessments
Not having serious mental disorders such as psychosis, bipolar type I or II
Not having suicidal thoughts
No abuse of benzodiazepines, antipsychotics, and SSRI medicines in the last 6 months
Exclusion criteria:
Need for medical intervention
Receiving psychotherapy sessions at the same time
Concerns about weight-related eating disorders
Unwillingness to continue participating at any time in the study
Absence of more than 3 sessions in treatment sessions
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
After the people with body dysmorphic disorder comorbid with emotional disorders were selected based on the inclusion and exclusion criteria, they will be allocated to two equal groups of treatment and control using the blocking randomization method. The coin toss method will be used to allocate people in each of the groups (Treatment and control). The blocking method will be used to balance the number of samples assigned to each of the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a clinical interview will be conducted by a clinical expert therapist to evaluate the inclusion and exclusion criteria. After obtaining informed consent to participate in the research, the participants will be randomly assigned to groups (treatment and control groups), in such a way that the participants have no knowledge of which group (treatment group or control group) they will be placed in. will not have Allocating participants in groups and taking the tests of this research in all three stages (Pre-treatment; post-treatment; follow-up) will be done by someone other than the therapist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in biomedical research
Street address
Pasdaran Blvd., University of Kurdistan., Central organization
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.UOK.REC.1402.015
Health conditions studied
1
Description of health condition studied
body dysmorphic disorder comorbid with emotional disorders
ICD-10 code
F45.22
ICD-10 code description
Body dysmorphic disorder
Primary outcomes
1
Description
Score of Body Image Concern from BICI questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Body Image Concern Inventory
2
Description
Score of depression and Anxiety from DASS-21 questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
DASS-21 questionnaire
Secondary outcomes
1
Description
Score of cognitive fusion from CFQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
CFQ questionnaire
2
Description
Score of cognitive emotion regulation from CERQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
CERQ questionnaire
3
Description
Score of cognitive avoidance from CAQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
CAQ questionnaire
4
Description
Score of difficulties in emotion regulation from DERS
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
DERS questionnare
5
Description
Score of anxiety sensitivity from ASI
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
ASI questionnaire
6
Description
Score of Problem-solving from Tower of London
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Tower of London software
7
Description
Score of inhibition from go/no go test
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Go/no go software
8
Description
Score of working memory from n-back test
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
N- back software
Intervention groups
1
Description
Intervention group: group 1: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 10, 45-minute individual treatment sessions. The UP targets and regulates emotional experiences by increasing emotion awareness and cognitive flexibility; identifying emotion-driven behaviors (EDBs) and replacing them with adaptive behaviors; identifying and preventing patterns of emotion avoidance; increasing awareness and confronting physical sensations, and facing emotions in situations. The treatment is preceded by enhancing the motivation and readiness of individuals for change and treatment engagement. Finally, the treatment ends by considering the progress of treatment and developing relapse prevention strategies.
Category
Treatment - Other
2
Description
Control group: wait-list group for Unified protocol.َAfter completion of follow-up sessions of intervention groups, the UP treatment will be applied as intervention group 1.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Counselling center of University of Kurdistan
Full name of responsible person
Mehdi Zemestani
Street address
Pasdaran Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87 3366 6746
Fax
Email
m.zemestan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Kurdistan
Full name of responsible person
Ali Akbar Mozafari
Street address
Pasdarsn Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
info@uok.ac.ir
Phone
+98 87 3362 7722
Fax
Email
a.mozafari@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Kurdistan
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
University of Kurdistan
Full name of responsible person
Fateme Etaati
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Pasdaran Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
087-33664600-8
Fax
+98 21 6600 0021
Email
fateme.etaati@uok.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Farzad Nasiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Pasdaran Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
087-33664601-2246
Email
nasiri.uok@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Fateme Etaati
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Pasdaran Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
087-33664600-8
Email
fateme.etaati@uok.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
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
Part of the data including information about the main consequence can be shared.
When the data will become available and for how long
Start of accessibility will be one year after printing the results.
To whom data/document is available
Data will only be available to researchers working in academic institutions.
Under which criteria data/document could be used
Requests for data are only permitted for intercultural studies or the studies of meta-analysis.
From where data/document is obtainable
Researchers can use the mentioned communication channel to receive the desired documents or data.
Email: nasiri.uok@yahoo.com
What processes are involved for a request to access data/document
Data will be provided by email or post after evaluation of the request.