Comparison of effectiveness of Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) With and without Transcranial direct current stimulation (TDCS) on improve executive functions, emotional disregulation, craving and attention bias in relation to the stimuli in adolescent with Substance use disorder
Determine the comparison of effectiveness of Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) With and without Transcranial direct current stimulation (TDCS) on improve executive functions, emotional disregulation, craving and attention bias in relation to the stimuli in adolescent with Substance use disorder
Design
The method of this study is a clinical trial with pretest-post test and follow-up with the control group.
Settings and conduct
After coordination with the well-being of Ardabil province, the plan begins.
Participants/Inclusion and exclusion criteria
Include criteria (age range of 18 to 21 years; diagnosis of substance use disorder based on DSM5 criteria; being male); and Exclude criteria (use of psychiatric medications ; diagnosis bipolar mood disorder or psychotic disorder Based on DSM5 criteria, intracranial implants and epileptic seizures.
Intervention groups
Three experimental groups (therapeutic groups) and one control group.
Main outcome variables
Executive Functions, Emotional Disregulation, Craving and Attention Bias in relation to the stimul
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181013041327N1
Registration date:2019-09-01, 1398/06/10
Registration timing:retrospective
Last update:2019-09-01, 1398/06/10
Update count:0
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
jaber Alizadehgoradel
Name of organization / entity
The University of shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 0055
Email address
j.alizadeh45@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) With and without Transcranial direct current stimulation (TDCS) on improve executive functions, emotional disregulation, craving and attention bias in relation to the stimuli in adolescent with Substance use disorder
Public title
Study the effect of tdcs and treatment of mindfulness in substance abuse disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 21 years
Detection of substance abuse disorder based on DSM5 criteria
Be a boy
Exclusion criteria:
Taking psychiatric medications
Diagnosis of bipolar mood disorder or psychotic disorder based on DSM5 criteria
Intracranial implants
History of epilepsy and seizure
Age
From 18 years old to 21 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For small study, you can use random digits table to sort people in groups.to use the random digits table, the participants in the study will be given a code or machine gun number, respectively. As many as 80 people will be selected. So the assigned codes and numbers will be two digits. To select sample individuals from the table, it will randomly start from a table point in the row or column direction. also,Individuals are randomly assigned to one of four study groups with the help of a random number table and receive the intervention of the same 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
Ethics committee of Shahid Beheshti University
Street address
Institute of Cognitive and Brain Sciences , Shahid Beheshti University, Shahid Shahriari Square, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
97/1036.IR.SBU.ICBS
Health conditions studied
1
Description of health condition studied
Substance use disorder
ICD-10 code
F19
ICD-10 code description
Other psychoactive substance related disorders
Primary outcomes
1
Description
Executive Functions
Timepoint
Before the intervention, after the intervention and three weeks after the intervention
Method of measurement
Wisconsin card sorting test, N-Back Test, Go/ No Go Task, Balloon Analogue Risk Taking Task
2
Description
Emotional Disregulation
Timepoint
Before the intervention, after the intervention and three weeks after the intervention
Method of measurement
DERS
3
Description
Craving
Timepoint
Before the intervention, after the intervention and three weeks after the intervention
Method of measurement
Craving Questionnaire(Franken & etal)
4
Description
Attention Bias in relation to the stimuli
Timepoint
Before the intervention, after the intervention and three weeks after the intervention
Method of measurement
Dot-Probe Task
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) With Transcranial direct current stimulation (TDCS):The Package of Mindfulness Therapy (Hamletstein & Saul, 2016) will be done in 12 sessions. Also, in the treatment of dTDCS, the dlpfc region will be stimulated by an active dose of 1/5 MA.
Category
Rehabilitation
2
Description
Intervention group: Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) Without Transcranial direct current stimulation (TDCS): This group will only have a healing mindfulness package (Hamletstein & Saul, 2016) during 12 sessions of therapy.
Category
Rehabilitation
3
Description
Intervention group: Transcranial direct current stimulation (TDCS): This group will receive only tdcs stimulation therapy.
Category
Rehabilitation
4
Description
sham group: receiving sham tdcs
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Welfare Aedebil province
Full name of responsible person
Behzad Sattari
Street address
Street of Shahid Vadood sad sale, Hafez Township
City
Ardabil
Province
Ardabil
Postal code
5615711116
Phone
+98 45 3371 2851
Email
b_sattari@sbu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cognitive Science and Technologies Council
Full name of responsible person
Mohammad Rostami
Street address
No 35, West Alvand, Argantin Square
City
Tehran
Province
Tehran
Postal code
15948
Phone
+98 21 8819 4956
Email
info@cogc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Science and Technologies Council
Proportion provided by this source
100
Public or private sector
Private
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
The University of Shahid Beheshti
Full name of responsible person
Jaber Alizadeh Goradel
Position
PHD Student Of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Addiction
Street address
Depatman of Clinical Psychology, Shahid Beheshti University, G.C. Evin
City
Tehran
Province
Tehran
Postal code
756555557509
Phone
+98 21 2990 5309
Email
j.alizadeh45@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Jaber Alizadeh Goradel
Position
PHD Student Of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Addiction
Street address
Departman of Clinical Psychology, Shahid Beheshti University, G.C. Evin,
City
Tehran
Province
Tehran
Postal code
756555557509
Phone
+98 21 2990 5309
Email
j.alizadeh45@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Jaber Alizadeh Goradel
Position
PHD Student Of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Addiction
Street address
Departeman of Clinical Psychology, Shahid Beheshti University, G.C. Evin,
City
Tehran
Province
Tehran
Postal code
756555557509
Phone
+98 21 2990 5309
Email
j.alizadeh45@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
A behavioral data file, a study protocol, a informed consent form, and a clinical study report after unidentifiable individuals can be shared.
When the data will become available and for how long
The beginning of the access period is 1 year after the publication of the results.
To whom data/document is available
The behavioral data of this research will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of data is permitted only for articles related to the field of addiction.
From where data/document is obtainable
Jaber Alizadeh Goradel, j.alizadeh45@gmail.com
What processes are involved for a request to access data/document
Researchers who want to access the data should receive a letter from the university at their place of work and send it to the responsible person's email address, in which case the data will be available to them in less than one month.