Effectiveness of transdiagnostic therapy based on the research domain criteria framework compared with treatment as usual and transcranial direct current stimulation for youth non-suicidal self-injury: A randomized controlled trial
Comparing the efficacy of a transdiagnostic therapy based on the research domain criteria framework (TTB-RDoC), with treatment as usual (TAU) and transcranial direct current stimulation (tDCS) in the treatment of youth nonsuicidal self-injury (NSSI)
Design
Clinical trial with control group, with parallel group, double-blind, randomized, phase 2 on 68 participants, SAS function rand software was used for randomization.
Settings and conduct
Place of study: Imam Hossein (AS), Ibn Sina Hospital, Waliasr (AS) Hospital, Mashhad;
Study population: men between 18 and 30 years old with a diagnosis of non-suicidal self-harm;
One-way blinding (participants were not aware of the design objectives)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primary DSM-5 diagnosis of NSSI; No usage of medication; Being at the age of 18-30 years old; Ability to participate in all assessment and treatment sessions.
Exclusion criteria: Receiving a full course of pharmacotherapy or psychotherapy, within the past 5 years; Having psychiatric disorders and substance abuse within twelve months before screening; Current diagnosis of any mental disorder; Patient's opposition to collaboration
Intervention groups
Intervention group 1: Transdiagnostic therapy based on research domain criteria framework; Intervention group 2: transcranial direct current stimulation; Control group: treatment as usual (cognitive-behavioral therapy)
Main outcome variables
Compare the efficacies of (TTB-RDoC), with (TAU) and (tDCS) in the treatment of youth NSSI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171029037068N1
Registration date:2023-09-23, 1402/07/01
Registration timing:retrospective
Last update:2023-09-23, 1402/07/01
Update count:0
Registration date
2023-09-23, 1402/07/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3868 0738
Email address
farrokhi.hossein@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-02, 1401/03/12
Expected recruitment end date
2022-08-05, 1401/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of transdiagnostic therapy based on the research domain criteria framework compared with treatment as usual and transcranial direct current stimulation for youth non-suicidal self-injury: A randomized controlled trial
Public title
Transdiagnostic therapy based on the research domain criteria framework for non-suicidal self-injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary DSM-5 diagnosis of non-suicidal self-injury (NSSI)
No usage of medication
Being at the age of 18-30 years old
Speaking Persian fluently
Ability to participate in all assessment and treatment sessions
Exclusion criteria:
Need for immediate medical treatment or the need for concurrent therapeutic interventions that would interfere with the treatment program
Receiving a full course of pharmacotherapy or psychotherapy, within the past 5 years
Having psychiatric disorders and substance abuse (except tobacco users) within twelve months before screening
Current diagnosis of any mental disorder
A history of epilepsy
Significant head injury or other neurological conditions, or brain surgery
A history of adverse reaction to tDCS or having a sensitive scalp
Patient's opposition to collaboration at any time of research
Having serious thoughts about suicide
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization method was performed with the help of SAS software. In this way, each subject is registered in the software and a code is defined for each person. Then, by means of the software, they are randomly divided into three intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants assumed that all participants would receive the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Ferdowsi University of Mashhad
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
09188355827
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.UM.REC.1400.033
Health conditions studied
1
Description of health condition studied
Nonsuicidal self-injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nonsuicidal self-injury
Timepoint
At baseline (pre-treatment), at 8th weeks (post-treatment), and after a 12-month post-treatment followup period.
Method of measurement
Inventory of statements about self-injury (ISAS), Structured clinical interview for DSM‐5 disorders‐clinician version
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: TTB-RDoC is a group intervention program for youth with NSSI (18–30-year-olds). It comprises 16 sessions (twice a week) of 45 min. This program consists of four modules. Module 1: Emotion Regulation, Module 2: Cognitive Training, Module 3: Behavioral Activation and Module 4: Interpersonal Skills. Each module is held in 4 sessions.
Category
Behavior
2
Description
Intervention group 2: The tDCS will deliver using two 5×7 cm electrodes covered in saline-soaked sponges. Electrodes were placed with a bipolar-balanced montage with anode on the right DLPFC (F4) and cathode on the left DLPFC (F3) according to EEG 10-20 system. tDCS was administered in a daily session lasting 20 min for 5 working days/week for 4 consecutive weeks
Category
Treatment - Devices
3
Description
Control group: TAU protocol includes new techniques from 'third' wave CBT, Acceptance Commitment Therapy (ACT) and Dialectical Behavior Therapy (DBT). The manual is evidence based and focuses on a flexible and formulation driven model to direct treatment in 15 sessions of 45 minutes and 2 sessions a week for young people. Cognitive-behavioral methodological techniques were performed in 5 sessions, including correction of cognitive errors, emotional regulation, and behavioral activation. Treatment techniques of commitment and acceptance in 5 sessions and included cognitive breakdown, self as background, conscious mind, values and acceptance and commitment.Dialectical behavioral therapy techniques in 5 sessions and included mindfulness, distress tolerance, interpersonal effectiveness and emotion control.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Hossein Farrokhi
Street address
Vahid 3, Vahid Avenue, Tollab Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188954652
Phone
+98 51 3278 7001
Email
info@imhh.ir
2
Recruitment center
Name of recruitment center
Ebn Sina Hospital
Full name of responsible person
Hossein Farrokhi
Street address
No 18, Moosavi GHoochani Blvd., Horre Ameli Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
ebnsinahos@gmail.com
3
Recruitment center
Name of recruitment center
Valiasr Medical Clinic
Full name of responsible person
Hossein Farrokhi
Street address
Vakil Abad 63, Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188955353
Phone
+98 51 3890 4390
Email
Valiasrclinic@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Mohammadreza Hosseindokht
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188355827
Phone
+98 51 3880 2420
Email
housain@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi University of Mashhad
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
Imanollah Bigdeli
Position
Professor of Psychology Department
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188355827
Phone
+98 51 3880 5865
Email
ibigdeli@um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Hossein Farrokhi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188355827
Phone
+98 51 3868 0489
Email
hossein.farrokhi110@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Hossein Farrokhi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188355827
Phone
+98 51 3868 0489
Email
hossein.farrokhi110@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
All potential data can be shared after de-identifying individuals
When the data will become available and for how long
The data will become available 3 months after the results are published
To whom data/document is available
There is no specific limitation and it will be accessible to all researchers in this field
Under which criteria data/document could be used
Currently, there are no special conditions and restrictions
From where data/document is obtainable
We will respond to applicants via email
What processes are involved for a request to access data/document
The aims and objectives of the research should be clearly explained.