Investigating the effect of Matrix psychotherapy along with a web-based treatment program on the relapse rate of patients with methamphetamine use disorder
Design
Clinical trial with control group, with parallel groups, double-blind, randomized. The method of randomization will be done by Excel software.
Settings and conduct
The place of implementation is Iran Psychiatric Hospital. Samples randomly in two groups; The group treated with matrix and web-based programs (N=30); And the group treated with matrix alone(N=30)
Participants/Inclusion and exclusion criteria
Being 18-50 years old, having the criteria of methamphetamine dependence according to DSM V, not being treated with other drugs affecting craving, the patient's desire and predicting that the patient may attend will have the study, access to a mobile phone, no simultaneous use of drugs and alcohol except for cigarettes
Intervention groups
30 patients in the first group will receive matrix psychotherapy along with web-based follow-up during 4 months (once a month); 30 patients in the second group will receive only matrix psychotherapy during 4 months (once every month).
Main outcome variables
The relapse rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056615N1
Registration date:2023-11-30, 1402/09/09
Registration timing:prospective
Last update:2023-11-30, 1402/09/09
Update count:0
Registration date
2023-11-30, 1402/09/09
Registrant information
Name
Neda Vahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
vahed.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
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
The effect of web-based interventions on the relapse rate of Methamphetamine use disorder at Iran psychiatric hospital
Public title
The effect of web-based interventions on the relapse rate of Methamphetamine use disorder at Iran psychiatric hospital
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 18 and 50 years old
Participants must meet the criteria for methamphetamine dependence according to DSM-V
The patient's desire and predicting that the patient will be able to participate in the study (including taking into account the distance and hours required for the patient to attend the treatment center)
Having access to a mobile phone
Exclusion criteria:
Taking other drugs that affect cravings (including modafinil, bupropion, naltrexone, N-acetylcysteine)
Simultaneous consumption of other substances and alcohol except cigarettes
Having severe psychiatric disorders
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Excel software will be used to generate a random sequence. Randomization will be done using blocks of 4 with two groups (experimental and control).
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator and statistical analyzer will not know the type of patient group, all evaluations will be done by code
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2023-07-14, 1402/04/23
Ethics committee reference number
IR.IUMS.REC.1402.352
Health conditions studied
1
Description of health condition studied
Patients with methamphetamine use disorder
ICD-10 code
F15
ICD-10 code description
Other stimulant related disorders
Primary outcomes
1
Description
Craving Score in Craving questionnaire
Timepoint
Before the intervention and once a month (up to 4 months)
Method of measurement
Obsessive Compulsive Drug Use Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: According to the matrix method, the intervention group will have face-to-face visits for psychotherapy every 4 weeks (depending on the patient's general condition and accompanying disorders, the patient may return earlier) and every 2 days they receive SMS and audio files with educational, motivational content and reminders of meeting times.The psychologists of the group will be in contact with the intervention group and the patient's family continuously and once a week by telephone. A patient who is a member of the intervention group, in case of encountering environmental triggers for relapse, informs the psychologist about the problem by sending a text message, and the therapist calls him immediately. The total intervention time will be 4 months
Category
Treatment - Other
2
Description
Control group: According to the matrix method, the control group will have a face-to-face visit for psychotherapy every 4 weeks (depending on the patient's general condition and associated disorders, the patient may return earlier). The whole treatment process will be up to 4 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatry Hospital
Full name of responsible person
Neda Vahed
Street address
Azadegan ring road., 6th km of Karaj Makhsoos road
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3395
Fax
+98 21 4450 3395
Email
vahedneda@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Reza Falak
Street address
Iran University of Medical Sciences., Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Neda Vahed
Position
Research fellow
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 914 614 7821
Email
vahedneda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Neda Vahed
Position
research fellow
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Shahid Mansouri St., Niayesh St., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
vahedneda@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Neda vahed
Position
Research fellow
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Shahid Mansouri Street., Niayesh Street., Sattar Khan Street
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 914 614 7821
Email
Vahedneda@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Outcomes after the intervention
When the data will become available and for how long
2024
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers from all scientific centers
From where data/document is obtainable
Email: vahedneda@yahoo.com
What processes are involved for a request to access data/document
The email of the requester for data/documents will be answered within 3 weeks