This study aims to reduce the harmful use of cannabis among teenagers and young people, while also increasing their motivation to quit using it.
Design
The clinical trial has an intervention and control group, a blinded, randomized, sample size of 48. The block randomization method was used for randomization
Settings and conduct
This research examines the effectiveness of a brief intervention on the harmful use of cannabis in teenagers and young adults who refer to Rasht Healing Hospital. The study begins by taking the ASSIST questionnaire from the eligible, and thus, those who are in the medium risk group in terms of cannabis use and who meet the other conditions to enter the intervention are included in the study. The samples are randomly divided into two control and intervention groups. be . Both groups are first asked to fill out a questionnaire to determine the amount of cannabis consumption and their desire and motivation to quit. After performing conventional treatment on both groups, the experimental group was subjected to a brief intervention by the researcher and the ASSIST was taken from both groups again.
Participants/Inclusion and exclusion criteria
Speak Persian
Be between 15 and 24 years old
Have the ability to read and write in Farsi language
The current consumers of cannabis and its derivatives include flowers, hashish, hashish oil, etc.
According to the ASSIST test, be in the medium-risk group
Do not use any other drugs except cannabis
The patient is not psychotic
Intervention groups
A brief intervention is designed based on the principles of motivational interviewing or motivational enhancement therapy, and the responsibility for change is placed on the patient.The control group is subjected to the usual treatment of cannabis use disorders, which is the psycho educational interview
Main outcome variables
Intensity of cannabis use based on the ASSIST
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231223060502N1
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
Zahra Farazi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 2350
Email address
zahrafarazimoghadam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effectiveness of Brief Intervention on Harmful Cannabis Use in Teenagers and Young Adults: A randomized controlled clinical trial
Public title
Investigation of the Effectiveness of Brief Intervention on Harmful Cannabis Use in Teenagers and Young Adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Speak Persian
Be between 15 and 24 years old
Have the ability to read and write in Farsi language
The current consumers of cannabis and its derivatives include flowers, hashish, hashish oil, etc.
According to the ASSIST test, be in the medium-risk group (a score in the range of 4-26)
Do not use any other drugs except cannabis (cigarettes and alcohol are excluded)
Consent to participate in the research
Exclusion criteria:
The patient is psychotic
Be in the acute phase of mania
Have cognitive impairment
Age
From 15 years old to 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups: intervention and control. This division is done using the block randomization method, containing 12 blocks and a block size of 4. The methodologies used to determine block randomization using the online software http://www.sealedenvelope.com are as follows:
The sequence is BBAA, BABA, BBAA, BBAA, AABB, ABBA, BBAA, ABBA, BBAA, ABBA, ABBA, BBAA.
Random allocation is performed by a psychiatric resident (researcher) using a sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
For blinding, for the final evaluation, self-reported questionnaires are used by the patients so that the researcher does not influence the research results. Also, a person different from the psychiatry resident who performed the interventions will perform the final evaluation.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gilan University of Medical Sciences
Street address
Guilan University of Medical Sciences' Headquarters - Parastar St. - Rasht
City
Rasht
Province
Guilan
Postal code
41937-13111
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.GUMS.REC.1402.444
Health conditions studied
1
Description of health condition studied
Harmful Cannabis Use
ICD-10 code
F12.1
ICD-10 code description
Mental and behavioral disorders due to use of cannabinoids : harmful us
Primary outcomes
1
Description
Intensity of cannabis use based on the ASSIST questionnaire
Timepoint
Upon arrival - 3 months of intervention - 3 months after intervention
Method of measurement
ASSIST questionnaire
Secondary outcomes
1
Description
Motivation and willingness to reduce and quit cannabis use and ASSIST score
Timepoint
Upon arrival - 3 months of intervention - 3 months after intervention
Method of measurement
Motivation Ruler for Leaving Drugs and ASSIST questionnaire
Intervention groups
1
Description
Intervention group: First, the common treatment method for cannabis use disorders, which is a psycho educational interview, is performed for the intervention group or experiment, and then they are treated with a brief intervention method (short-term intervention). Brief intervention is done to identify current or potential drug use problems and motivate people at risk to change drug use behavior. Brief interventions in primary care can be from 5 minutes of brief advice to 15 to 30 minutes of brief counseling. The components of brief intervention are: 1- Feedback (Feedback) 2- Responsibility (Responsibility) 3- Advice (Advice) 4- Change options menu (Menu of alternative change options) 5- Empathy 6- Self-efficacy
Category
Behavior
2
Description
Control group: Control group: The control group is subjected to the usual treatment of cannabis use disorders, which is the psychoeducational interview
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Educational and Remedial Center
Full name of responsible person
Hadi Rahimi
Street address
Shafa Hospital, Dr heshmat Cross, Dr Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
41936-55599
Phone
+98 13 3366 2325
Email
shafahospitalrasht@gmail.com
Web page address
https://shafa.gums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Mohamad Taghi Ashubi
Street address
Guilan University of Medical Sciences' Headquarters - Parastar St. - Rasht
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3334 5308
Email
riasat@gums.ac.ir
Web page address
https://gums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
1
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
Rasht University of Medical Sciences
Full name of responsible person
Zahra Farazi Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shafa Hospital, Dr heshmat Cross, Dr Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
41936-55599
Phone
+98 13 3366 2350
Email
shafahospitalrasht@gmail.com
Web page address
https://shafa.gums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Farazi Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shafa Hospital, Dr heshmat Cross, Dr Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
41936-55599
Phone
+98 13 3366 2350
Fax
Email
zahrafarazimoghadam@gmail.com
Web page address
https://shafa.gums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Farazi Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shafa Hospital, Dr heshmat Cross, Dr Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
41936-55599
Phone
+98 13 3366 2350
Fax
Email
zahrafarazimoghadam@gmail.com
Web page address
https://shafa.gums.ac.ir/
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
Compliance with ethical principles and preventing the publication of personal and private information of patients
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available