Protocol summary
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Study aim
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The aim of this study is to evaluate the impact of Matrix treatment on marijuana craving and psychological capacity among cannabis users.
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Design
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Parallel groups randomized trial with control group, unblinded, will be used to randomize Stat Trek computer software.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Psychological capital, marijuana intensity and cravings (primary consequences), mental health, generalized anxiety, checklists, and self-efficacy in marijuana withdrawal (secondary consequences)
General information
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Reason for update
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Announcement of the ending date of the trial
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Acronym
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CUD
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IRCT registration information
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IRCT registration number:
IRCT20240723062524N1
Registration date:
2024-07-27, 1403/05/06
Registration timing:
prospective
Last update:
2024-12-06, 1403/09/16
Update count:
2
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Registration date
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2024-07-27, 1403/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-08-01, 1403/05/11
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Expected recruitment end date
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2024-09-01, 1403/06/11
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Actual recruitment start date
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2024-08-01, 1403/05/11
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Actual recruitment end date
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2024-08-22, 1403/06/01
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Trial completion date
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2024-12-03, 1403/09/13
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Scientific title
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The Effectiveness of Matrix Treatment on Craving and Psychological Capital in cannabis users
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Public title
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The Effectiveness of Psychological Treatment in adults with cannabis use disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be performed with a simple method and random numbers generated by computer software (Stat Trek software), which chooses the random numbers.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-06-27, 1403/04/07
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Ethics committee reference number
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IR.IAU.NAJAFABAD.REC.1403.097
Health conditions studied
1
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Description of health condition studied
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Cannabis Use Disorder (CUD)
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ICD-10 code
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F12.1
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ICD-10 code description
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Cannabis abuse
2
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Description of health condition studied
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Cannabis Withdrawal Disorder (CWD)
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ICD-10 code
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F12.2
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ICD-10 code description
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Cannabis dependence
Primary outcomes
1
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Description
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Marijuana Craving Score
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Timepoint
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Before and after the intervention
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Method of measurement
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Marijuana Craving Questionnaire (MCQ)
2
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Description
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Diagnosis of cannabis use and severity
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Timepoint
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At the onset of both the study and the intervention
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Method of measurement
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The Structured Clinical Interview for Clinical Trials version (SCID-5-CT).
3
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Description
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Psychological Capital Score
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Timepoint
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Before and after the intervention
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Method of measurement
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Psychological Capital Questionnaire (PCQ)
4
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Description
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Diagnosis of cannabis use and severity
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Timepoint
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At the onset of the study and one month after the completion of the intervention,
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Method of measurement
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The Cannabis Use Disorders Identification Test (CUDIT-R-Pr) has been revised in Persian.
5
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Description
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Negative urine test for cannabis
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Timepoint
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Before intervention and 3, 6, 9, 12 and 16 weeks after intervention
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Method of measurement
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Cannabis urine test
Secondary outcomes
1
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Description
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Patient Health Score
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Timepoint
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Before and after the intervention
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Method of measurement
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Patient Health Questionnaire (PHQ-9)
2
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Description
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General Anxiety Disorder Score
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Timepoint
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Before and after the intervention
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Method of measurement
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General Anxiety Disorder Questionnaire (GAD-7)
3
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Description
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The Marijuana Withdrawal Checklist to assess the incidence and severity of perceived withdrawal symptoms
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Timepoint
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Before and after the intervention
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Method of measurement
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The Marijuana Withdrawal Checklist (MWC)
4
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Description
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Self-Efficacy Score to abstinence from marijuana
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Timepoint
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Before and after the intervention
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Method of measurement
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The Self-Efficacy Questionnaire (SEQ) for abstinence from marijuana
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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).
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Category
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Treatment - Other
3
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Description
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The control group is non-intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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West Tehran Branch of Islamic Azad University
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The main variables and demographic data, including age, gender, marital status, and education
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When the data will become available and for how long
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One year following the publication of the results
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To whom data/document is available
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It will only be available to researchers in academic and scientific institutions.
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Under which criteria data/document could be used
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To train and treat substance use and cannabis disorders
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From where data/document is obtainable
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Correspondence with the west Tehran branch of Islamic Azad University, Tehran, Iran info@wtiau.ac.ir
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What processes are involved for a request to access data/document
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Correspondence with the Faculty of Medicine Sciences at the west Tehran branch of Islamic Azad University, Tehran, Iran info@wtiau.ac.ir
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Comments
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