Evaluation of the effect of psychological intervention through telephone follow-up on the rate of avoidance of amphetamines and opioids in men with substance use disorders discharged from hospital
Determining the effect of psychological intervention through telephone follow-up on the rate of abstinence from amphetamines and opioids in men with substance use disorder discharged from the hospital
Design
Clinical trial with control group, with parallel groups, Not randomized
Settings and conduct
106 patients discharged from Ibn Sina Psychiatric Hospital in Mashhad, who will be included in the study based on the Inclusion Criteria after obtaining informed consent. The ASI questionnaire will be completed before and one month after the intervention for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness of the Patient to participate in the Study,
Age between 18-64 years old and Access to mobile or landline phones. Exclusion criteria: Persistent psychosis at discharge, Chronic physical illness accompanied by pain, Patient refusal to cooperate.
Intervention groups
In intervention group, after the discharge of the patient, psychological training based on cognitive behavioral interventions (inspired by the matrix) will be available to patients in the form of text messages, which include psychological education to patients about the necessity of taking drugs, management of emotion regulation and control of temptation and motivation to quit and recovery, and also contain questions such as whether before How did they feel after consuming? What kind of environment were they in and what stressors did they have? . In control group, participants will not go anywhere for treatment after discharge and also will not followed up.
Main outcome variables
Addiction Severity score in the Addiction Severity Index questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221001056065N2
Registration date:2023-01-15, 1401/10/25
Registration timing:retrospective
Last update:2023-01-15, 1401/10/25
Update count:0
Registration date
2023-01-15, 1401/10/25
Registrant information
Name
Maedeh Kamrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3700 2202
Email address
kamranim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-11, 1401/06/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
2022-09-21, 1401/06/30
Actual recruitment end date
2022-11-21, 1401/08/30
Trial completion date
empty
Scientific title
Evaluation of the effect of psychological intervention through telephone follow-up on the rate of avoidance of amphetamines and opioids in men with substance use disorders discharged from hospital
Public title
Investigating the effect of psychological intervention on the rate of abstinence from amphetamines and opioids in men
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness of the Patient to participate in the research
Age of the Patient between 18-64 years old
Access to mobile or landline phones
Exclusion criteria:
Persistent psychosis at discharge
Chronic physical illness accompanied by pain
Patient refusal to cooperate
Age
From 18 years old to 64 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Actual sample size reached:
58
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics Committee of Mashhad Azad University of Medical Sciences
Street address
No. 14, Bazarche Sarab, Imam Khomeini St
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Approval date
2022-02-23, 1400/12/04
Ethics committee reference number
IR.IAU.MSHD.REC.1401.001
Health conditions studied
1
Description of health condition studied
Users of amphetamines and opioids
ICD-10 code
F48.9
ICD-10 code description
Nonpsychotic mental disorder, unspecified
Primary outcomes
1
Description
Addiction Severity score in the Addiction Severity Index questionnaire
Timepoint
Before the intervention and at the end of the first month
Method of measurement
Addiction Severity Index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this Group, after the discharge of the patient, it is explained to the patients who are not able to go in person for psychotherapy or support measures by obtaining a written consent form and phone number from them that every day after the discharge, psychological training based on cognitive behavioral interventions (inspired by the matrix) will be available to patients in the form of text messages, which include psychological education to patients about the necessity of taking drugs, management of emotion regulation and control of temptation and motivation to quit and recovery, and also contain questions such as whether before How did they feel after consuming? What kind of environment were they in and what stressors did they have?
Category
N/A
2
Description
Control group: In this group,Patients will not go anywhere for treatment after discharge and also will not followed up.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne shina Hospital
Full name of responsible person
Maedeh Kamrani
Street address
Bo Ali Square, Horr Ameli Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2701
Fax
+98 51 3711 2701
Email
kamranim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Touraj Zandbaf
Street address
No. 14, Bazarche Sarab, Imam Khomeini St
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83143
Phone
+98 51 3225 0041
Fax
+98 51 3225 0041
Email
elahehedalati75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
maedeh kamrani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Bo Ali Square, Harameli Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2701
Email
kamranim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maedeh kamrani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Bo Ali Square, Horr Ameli Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2701
Email
kamranim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elaheh Edalatifar
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 304, 10 Amirkabir
City
Mashhad
Province
Razavi Khorasan
Postal code
9175784564
Phone
+98 915 428 2252
Email
elahehedalati75@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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