Protocol summary

Study aim
The investigation of matrix psychotherapy on drug consumption, craving, and performance in adolescents
Design
A clinical trial with no control group, with a pre-test and post-test design, randomized, double-blind, study on 20 patients
Settings and conduct
This study will be a clinical trial with a pre-test and post-test design. The studied subjects are adolescent boys with stimulant or cannabis use disorders who refer to psychiatric clinics affiliated to Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion: 1- A person with stimulant substance use disorder according to DSM V 2-Male sex 3- Age 12 to 18 years 4- Verbal consent of the teenager to participate in the study Exclusion: 1- Having a serious medical disorder such as diabetes and epilepsy 2- Existence of psychotic disorders 3- Being in an active emotional phase
Intervention groups
This study has no control group and the investigation is conducted as a pre-test and post-test. The intervention group will undergo matrix therapy sessions. The meetings will be held weekly and each meeting will be between 1 to 1.5 hours.
Main outcome variables
Age; Education; Consumption; Matrix therapy method; Children's Global Assessment Scale score; Material temptation score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230805059049N1
Registration date: 2023-08-25, 1402/06/03
Registration timing: registered_while_recruiting

Last update: 2023-08-25, 1402/06/03
Update count: 0
Registration date
2023-08-25, 1402/06/03
Registrant information
Name
Farnaz Golmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
farnazgolmohammadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of matrix psychotherapy on craving in adolescents with stimulants and cannabis use disorder
Public title
Investigating the matrix on the amount of drug use in adolescents
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
A person with stimulant and cannabis use disorder diagnosed based on clinical interview and DSM V criteria Male gender Age 12 to 18 years Oral consent of the adolescent to participate in the study Obtaining written consent from the parent or primary protectors of the adolescent
Exclusion criteria:
Having a serious medical disorder such as diabetes and epilepsy The presence of psychotic disorders Being in an active mood phase
Age
From 12 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2023-07-23, 1402/05/01
Ethics committee reference number
IR.MUI.MED. REC.1402.095

Health conditions studied

1

Description of health condition studied
Substance Use Disorder (SUD)
ICD-10 code
F19.14
ICD-10 code description
Other psychoactive substance abuse with psychoactive substance-induced mood disorder

Primary outcomes

1

Description
Children's Global Assessment Scale score
Timepoint
Matrix therapy method
Method of measurement
Questionnaire measuring the temptation to use drugs after quitting drugs

Secondary outcomes

1

Description
Material temptation score
Timepoint
The intervention group will undergo matrix therapy sessions. The meetings will be held weekly and the duration of each meeting will be between 1 and 1.5 hours.
Method of measurement
Questionnaire measuring the temptation to use drugs after withdrawal

Intervention groups

1

Description
Intervention group: will undergo matrix therapy sessions. The meetings will be held weekly and the duration of each meeting will be between one and one and a half hours. Children's Global Assessment Scale and Substance Temptation Questionnaire after withdrawal will be completed for all subjects before treatment sessions begin.After completing the treatment sessions, the mentioned questionnaires will be completed again. The scores of these scales will be compared before and after. One month and two months after the completion of the Matrix sessions, re-evaluation will be done with the substance temptation questionnaire after quitting and the Children's Global Assessment Scale.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric clinics affiliated to Isfahan University of Medical Sciences
Full name of responsible person
Farnaz Golmohammadi
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
7344181746
Phone
+98 31 3669 2760
Fax
+98 31 3668 7021
Email
Farnazgolmohammadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Golmohammadi
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3669 2760
Fax
+98 31 3668 7021
Email
Farnazgolmohammadi@gmail.com
Grant name
Isfahan University of Medical Sciences and Health Services
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Golmohammadi
Position
Assistant Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3669 2760
Email
Farnazgolmohammadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Golmohammadi
Position
Assistant Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3669 2760
Email
Farnazgolmohammadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Golmohammadi
Position
Assistant Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3669 2760
Email
Farnazgolmohammadi@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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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