Compilation Of Effectiveness of Compassionate Mind-Based Cognitive Therapy and Transcranial Direct Electrical Stimulation on Brain-Behavioral Systems, Dark Personality Traits, and the Theory of mind Adolescents with high-risk behaviors.
Comparison of the effectiveness of cognitive therapy based on compassionate mind and direct transcranial electrical stimulation on brain-behavioral systems, dark personality traits and mind theory of adolescents with high-risk behaviors
Design
The present research method was a quasi-experimental and comparative experiment in which a pre-test/post-test design with two experimental groups and one control group was used.
Settings and conduct
This study was performed in Bozorgmehr Counseling Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a high-risk behaviors; willingness to participate in the study; not suffering from other disorders. Non-inclusion criteria: Participate in other intervention programs at the same time.
Intervention groups
The first intervention group was exposed to direct ultrasonic electrical stimulation, and the second experimental group was exposed to Compassionate Mind-Based Cognitive Therapy. The control group did not receive any treatment.
Main outcome variables
Brain-Behavioral Systems, Dark Personality Traits, and the Theory of Mind
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200209046441N1
Registration date:2021-01-25, 1399/11/06
Registration timing:retrospective
Last update:2021-01-25, 1399/11/06
Update count:0
Registration date
2021-01-25, 1399/11/06
Registrant information
Name
hamidreza Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3328 0605
Email address
hamiddehghan313@umz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-30, 1399/10/10
Actual recruitment start date
2020-11-30, 1399/09/10
Actual recruitment end date
2021-01-16, 1399/10/27
Trial completion date
2021-01-17, 1399/10/28
Scientific title
Compilation Of Effectiveness of Compassionate Mind-Based Cognitive Therapy and Transcranial Direct Electrical Stimulation on Brain-Behavioral Systems, Dark Personality Traits, and the Theory of mind Adolescents with high-risk behaviors.
Public title
Mind-Based Cognitive Therapy and Transcranial Direct Electrical Stimulation on Brain-Behavioral Systems, Dark Personality Traits, and the Theory of mind Adolescents with high-risk behaviors and self-harm behaviors.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having high-risk behaviors based on a screening questionnaire
Willingness to participate in the study
No other mental disorders
Exclusion criteria:
Participate in other intervention programs at the same time
Age
From 15 years old to 17 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
36 students with high-risk behaviors were randomly selected and then completely randomly (based on lottery) were divided two groups of 15 experiments and one group controls. Allocation was done through drawing a code in which every student was given a code and we put the codes in a container. Then 15 people who were taken out first were replaced in the first experimental group, 15 people later in the second experimental group and 18 people later in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Basmanj Street. Medical School - Second Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5351869012
Approval date
2020-12-30, 1399/10/10
Ethics committee reference number
IR.IAU.TABRIZ.REC.1399.146
Health conditions studied
1
Description of health condition studied
Specific learning disability
ICD-10 code
یادگیری
ICD-10 code description
F81.0
Primary outcomes
1
Description
Behavioral brain systems
Timepoint
Before and after the intervention
Method of measurement
questionnaire
2
Description
Dark personality traits
Timepoint
Before and after the intervention
Method of measurement
questionnaire
3
Description
قبل و بعد از مداخله
Timepoint
Before and after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Transcranial Direct-Current Stimulation (tDCS) is a technique used to modify and modify brain function, which is now used as a healthy and effective procedure to treat most neurological conditions and even in medicine. Electrical Stimulation Technique A neural modification method that transmits electric current to a specific point in the skull over a very specific period of time, including an anode electrode that stimulates the nervous system and a cathode electrode that inhibits the nervous system. To stimulate the centers of the prefrontal cortex, this is responsible for controlling the complex movements of the anode electrode on the prefrontal cortex and the cathode electrode on the opposite shoulder (according to the 10-20 EEG system). Participants sit in a comfortable chair in a quiet room with no other sensory stimuli. Electrical stimulation of the brain by tDCS (Canadian-made Mind-Alif brand device) was instilled in students in a steady stream with a constant current of between 1.5 and 2 mA (intensity appropriate for client tolerance). Every other day and for 10 days, using a pair of 5×5 cm rubber electrodes covered with artificial sponge soaked in a normal saline solution and placed in the desired areas.
Category
Treatment - Other
2
Description
Control group: They did not receive any treatment.
Category
Treatment - Other
3
Description
Intervention group: Cognitive therapy based on a compassionate mind: Compassionate mind training is one of the psychotherapy methods in which empathy, empathy, compassion, acceptance and tolerance, responsibility and a sense of worth are taught (Gilbert, 2009). This treatment is designed by the research activities of Gilbert (2005). In the present study, this treatment method will be held in 12 sessions, each session for 90 minutes and in groups once a week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bozorgmehr Counseling Center
Full name of responsible person
Dr. Seyed Mahmoud Tabatabai
Street address
Bozorgmehr Counseling Center, in front of Education District 2, 17 Shahrivar Jadid St., Tabriz City.
City
tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3228 5645
Email
smt11351@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Mazandaran
Full name of responsible person
Alireza Khasali
Street address
Deputy of Research and Technology, Central Organization, Pasdaran St.
City
babolsar
Province
Mazandaran
Postal code
4741613534
Phone
+98 11 3530 3300
Email
khesali@umz.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Mazandaran
Proportion provided by this source
5
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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamidreza Dehghan
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, first floor, water apartments, Farmandari street, Farhangian alley.
City
tabriz
Province
East Azarbaijan
Postal code
5351869012
Phone
+98 41 3322 4021
Email
hamidreza.dehghan313@ymz.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Habibolah Naderi
Position
Assistant Professor of Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Humanities and Social Sciences, University Blvd., Campus of Mazandaran University, Shahid Zolfaghari Blvd.
City
babolsar
Province
Mazandaran
Postal code
4741613534
Phone
35303565
Email
h.naderi@umz.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Hamidreza Dehghan
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, first floor, Water Apartments, Farmandari Street, Farhangian alley.
City
Tabriz
Province
East Azarbaijan
Postal code
5351869012
Phone
+98 919 913 3406
Email
Hamidreza.Dehghan313@yahoo.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
There is no need to publish data.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The collected data were analyzed using SPSS-23 software.
When the data will become available and for how long
-----
To whom data/document is available
Supervisors, consultants and referees
Under which criteria data/document could be used
------
From where data/document is obtainable
To the dissertation
What processes are involved for a request to access data/document