the determining effect of supportive-educational therapy group on the level of self-care in clients undergoing methadone treatment.
Design
This study is a parallel clinical trial with an experimental and control group.
Settings and conduct
Study Subjects Drug users now receiving methadone in MMT centers. These people will be selected from MMT clinics in Khorram Abad-Lorestan after obtaining informed consent and will be organized into two groups. One group received self-care training and the other group received no training.
Participants/Inclusion and exclusion criteria
Willingness to participate in the study, at least six months of methadone use, age over 18 years and not having a mental illness, and withdrawal criteria for withdrawing from participating in the study, in case of absenteeism for several sessions, were determined.
Intervention groups
Educational-supportive intervention for the intervention group in 8 supportive-educational group therapy sessions of 5.1/5 hours (the topics of the session will be designed based on past studies as well as authentic books. The control group will receive only the usual interventions of drug abuse clinics.
Main outcome variables
self care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221106056412N1
Registration date:2023-01-25, 1401/11/05
Registration timing:registered_while_recruiting
Last update:2023-01-25, 1401/11/05
Update count:0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
Amir Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3845 6866
Email address
jalali_amir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive-educational group therapy on the level of self-care in clients under MMT methadone
Public title
The effect of supportive-educational group therapy on the level of self-care in clients under MMT methadone
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in the study,
At least six months of methadone use
Age above 18 years
Not having a mental illness
Exclusion criteria:
The only condition for withdrawal from the study was defined as being absent for several sessions.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the block method and with blocks of size 4 and 6 by the methodology consultant
Blinding (investigator's opinion)
Single blinded
Blinding description
Unlabeled codes are entered into the data and the data is analyzed blindly.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics in Research of Kermanshah University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Isar Square, Bahnar Blvd, Dolatabad Town
City
kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.KUMS.REC.1401.227
Health conditions studied
1
Description of health condition studied
Drug users
ICD-10 code
F11
ICD-10 code description
Opioid related disorders
Primary outcomes
1
Description
Self- care
Timepoint
Self-care measurement will be done at the beginning of the study (before the start of the intervention) and after 8 weeks after the start of the intervention.
Method of measurement
The self-care ability questionnaire is based on Orem's self-care model, which was used for the first time in the research of Moghadamnia et al. (2014), and it is used to measure self-care ability and mental health self-care.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, addiction treatment is conducted in 8 sessions of group therapy with a supportive educational approach for 90 minutes and one session every week for the clients of the intervention group in addition to the usual interventions of the clinics. Group therapy sessions are held in each session with topics such as drug abuse, lifestyle, relapse, treatment and rehabilitation process, and other issues.
Category
Lifestyle
2
Description
Control group: The control group will receive only the usual interventions of addiction treatment clinics.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Taravat Methadone Maintenance Treatment clinic
Full name of responsible person
Amir Jalali
Street address
Taravat MMT Clinic, second floor,Razi St, next to Sina Pharmacy
City
Khorramabad
Province
Lorestan
Postal code
6816166667
Phone
+98 66 3342 5534
Email
jalali_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
No. 2,Medical Sciences Building,Research and Technology Vice-Chancellor,Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3839 3154
Fax
+98 83 3838 6835
Email
jalali_amir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Jalali
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isar Square, Bahnar Blvd, Dolatabad Town
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3839 3154
Email
Jalali_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Jalali
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isar Square, Bahnar Blvd, Dolatabad Town
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
009838393154
Email
jalali_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Jalali
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isar Square, Bahnar Blvd, Dolatabad Town
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3839 3154
Email
jalali_amir@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The report will be provided only in the form of printed articles in scientific journals.
When the data will become available and for how long
The report will be provided only in the form of printed articles in scientific journals.
To whom data/document is available
The report will be provided only in the form of printed articles in scientific journals.
Under which criteria data/document could be used
The report will be provided only in the form of printed articles in scientific journals.
From where data/document is obtainable
The report will be provided only in the form of printed articles in scientific journals.
What processes are involved for a request to access data/document
The report will be provided only in the form of printed articles in scientific journals.
Comments
Considering that in the above sections, we have not agreed to share, but in the lower sections, we have been asked to provide explanations, which has caused confusion.