The aim of this study is to evaluate the impact of Matrix treatment on marijuana craving and psychological capacity among cannabis users.
Design
Parallel groups randomized trial with control group, unblinded, will be used to randomize Stat Trek computer software.
Settings and conduct
In eight sessions, the first group of 20 mild-intensity cannabis users will receive matrix therapy individually, as well as with their families. The second group, which consists of 20 moderate and severe cannabis users, will receive matrix therapy in 12 group sessions, while a control group of 20 cannabis users will receive no intervention. We will conduct meetings online and in person face-to-face in the psychology clinic of the Azad University-West Tehran branch.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Participants must have at least twelve months of experience with marijuana use. They must also avoid stimulant drugs other than cigarettes and marijuana, be between 18 and 50 years of age, and have signed an ethical form indicating their consent.
Exclusion criteria:
Participants who require more advanced care than what an outpatient group can provide, are concurrently receiving another medical or psychological intervention, are unavailable during study sessions, have missed more than four sessions, or have any psychiatric or physical disability.
Intervention groups
The first experimental group receives a matrix intervention based on family counseling, cognitive-behavioral therapy (CBT), motivational enhancement therapy (MET), and contingency management (CM). The second experimental group receives CBT plus MET, and the third group is non-intervention control.
Main outcome variables
Psychological capital, marijuana intensity and cravings (primary consequences), mental health, generalized anxiety, checklists, and self-efficacy in marijuana withdrawal (secondary consequences)
General information
Reason for update
Acronym
CUD
IRCT registration information
IRCT registration number:IRCT20240723062524N1
Registration date:2024-07-27, 1403/05/06
Registration timing:prospective
Last update:2024-07-27, 1403/05/06
Update count:2
Registration date
2024-07-27, 1403/05/06
Registrant information
Name
Mahmood Amirinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2642 8730
Email address
mahmood.amirinia@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-01, 1403/05/11
Expected recruitment end date
2024-09-01, 1403/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Matrix Treatment on Craving and Psychological Capital in cannabis users
Public title
The Effectiveness of Psychological Treatment in adults with cannabis use disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
According to the fifth edition of the Diagnostic and Statistical Mental Health Analysis, Text Revision Criteria (DSM-5-TR), participants must have at least twelve months of experience with marijuana use.
They must also avoid stimulant drugs other than cigarettes and marijuana.
The participants must be between 18 and 50 years of age and have signed an ethical form indicating their consent.
Exclusion criteria:
Participants who require more advanced care than what an outpatient group can provide, such as those experiencing active mania or psychosis.
Any psychiatric or physical condition may find it challenging to communicate effectively.
The participant is concurrently receiving another medical or psychological intervention that is based on cognitive behavior therapy.
Participants who are unavailable during study sessions and have missed more than four sessions.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with a simple method and random numbers generated by computer software (Stat Trek software), which chooses the random numbers.
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
Islamic Azad University- Najafabad branch
Street address
University Sq., Najafabad, Isfahan, Iran
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2024-06-27, 1403/04/07
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1403.097
Health conditions studied
1
Description of health condition studied
Cannabis Use Disorder (CUD)
ICD-10 code
F12.1
ICD-10 code description
Cannabis abuse
2
Description of health condition studied
Cannabis Withdrawal Disorder (CWD)
ICD-10 code
F12.2
ICD-10 code description
Cannabis dependence
Primary outcomes
1
Description
Marijuana Craving Score
Timepoint
Before and after the intervention
Method of measurement
Marijuana Craving Questionnaire (MCQ)
2
Description
Diagnosis of cannabis use and severity
Timepoint
At the onset of both the study and the intervention
Method of measurement
The Structured Clinical Interview for Clinical Trials version (SCID-5-CT).
3
Description
Psychological Capital Score
Timepoint
Before and after the intervention
Method of measurement
Psychological Capital Questionnaire (PCQ)
4
Description
Diagnosis of cannabis use and severity
Timepoint
At the onset of the study and one month after the completion of the intervention,
Method of measurement
The Cannabis Use Disorders Identification Test (CUDIT-R-Pr) has been revised in Persian.
5
Description
Negative urine test for cannabis
Timepoint
Before intervention and 3, 6, 9, 12 and 16 weeks after intervention
Method of measurement
Cannabis urine test
Secondary outcomes
1
Description
Patient Health Score
Timepoint
Before and after the intervention
Method of measurement
Patient Health Questionnaire (PHQ-9)
2
Description
General Anxiety Disorder Score
Timepoint
Before and after the intervention
Method of measurement
General Anxiety Disorder Questionnaire (GAD-7)
3
Description
The Marijuana Withdrawal Checklist to assess the incidence and severity of perceived withdrawal symptoms
Timepoint
Before and after the intervention
Method of measurement
The Marijuana Withdrawal Checklist (MWC)
4
Description
Self-Efficacy Score to abstinence from marijuana
Timepoint
Before and after the intervention
Method of measurement
The Self-Efficacy Questionnaire (SEQ) for abstinence from marijuana
Intervention groups
1
Description
The first intervention group consists of mild cannabis users who receive matrix intervention in 8 to 12 sessions based on family counseling, cognitive-behavioral therapy (CBT), motivational enhancement therapy (MET), and contingency management (CM) individually and with their families in two sessions per week.
Category
Treatment - Other
2
Description
The second intervention group includes moderate and severe cannabis users who receive matrix intervention in 12 to 16 sessions based on individual and weekly cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET).
Category
Treatment - Other
3
Description
The control group is non-intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
The morning of freedom addiction treatment center
Full name of responsible person
Dr. Ruhollah Haddadi
Street address
The southeast side of Nabot Square, at the end of Fatima Zahra Street, above the central Narmak pharmacy
City
Tehran
Province
Tehran
Postal code
1649965941
Phone
+98 21 7794 8993
Email
info@ravanesepid.com
2
Recruitment center
Name of recruitment center
Psychological Clinic of Islamic Azad University -West Tehran Branch
Full name of responsible person
Dr. Saeedeh Zomorodi
Street address
Simaye Iran Ave., Farahzadi Blvd., Qods Town., West Tehran Branch of Islamic Azad University
City
تهران
Province
Tehran
Postal code
1468763785
Phone
+98 21 8838 5771
Email
mahmoodamirinia@yahoo.com
3
Recruitment center
Name of recruitment center
Islamic Azad University Central Tehran Branch Faculty Psychology and Social Sciences
Full name of responsible person
Dr. Alireza Mollazadeh
Street address
Artesh Blvd., Sohanak., Islamic Azad University Central Tehran Branch Faculty Psychology and Social Sciences
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 2248 1634
Fax
Email
alimollazade@yahoo.com
4
Recruitment center
Name of recruitment center
Kharazmi University
Full name of responsible person
Dr. Ayat Saadat Talab
Street address
No.43, South Mofateh St., Kharazmi University
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 8832 9220
Email
a.saadattalab@khu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahmood Amirinia
Street address
simaye Iran Ave., Farahzadi Blvd., Qods Town, Faculty of Medicine Sciences, West Tehran Branch of Islamic Azad University
City
Tehran
Province
Tehran
Postal code
1468763785
Phone
+98 21 8838 5771
Email
Mahmood.Amirinia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
West Tehran Branch of Islamic Azad University
Proportion provided by this source
10
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
Islamic Azad University
Full name of responsible person
Alireza Mollazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Emam Khomeini Blvd, Department of Psychology, Ashtian Branch of Islamic Azad University, Ashtiyan, Markazi Province, Iran
City
Ashtian
Province
Markazi
Postal code
3961813347
Phone
+98 86 3722 2500
Fax
+98 86 3722 2880
Email
alimollazade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Mollazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Emam Khomeini Blvd, Department of Psychology, Ashtian Branch of Islamic Azad University, Ashtian, Iran.
City
Ashtian
Province
Markazi
Postal code
3961813347
Phone
+98 86 3722 2500
Fax
+98 86 3722 2880
Email
alimollazade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahmood Amirinia
Position
researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Dadman Blv . Derakhti St . Saghafi St . No 16 . Terhran . Iran Central Office Of West Tehran Branch ,Islamic Azad Uni
City
Tehran
Province
Tehran
Postal code
1468763785
Phone
+98 21 8838 5771
Fax
Email
mahmood.amirinia@iau.ir
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
The main variables and demographic data, including age, gender, marital status, and education
When the data will become available and for how long
One year following the publication of the results
To whom data/document is available
It will only be available to researchers in academic and scientific institutions.
Under which criteria data/document could be used
To train and treat substance use and cannabis disorders
From where data/document is obtainable
Correspondence with the west Tehran branch of Islamic Azad University, Tehran, Iran info@wtiau.ac.ir
What processes are involved for a request to access data/document
Correspondence with the Faculty of Medicine Sciences at the west Tehran branch of Islamic Azad University, Tehran, Iran info@wtiau.ac.ir