Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140907019077N4
Registration date: 2017-12-12, 1396/09/21
Registration timing: registered_while_recruiting

Last update: 2017-12-12, 1396/09/21
Update count: 0
Registration date
2017-12-12, 1396/09/21
Registrant information
Name
Sonia Oveisi
Name of organization / entity
Qazvin Unversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
soveisi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences - Vice chancellor of research - Dr. Peimani
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of motivational interviewing-based behavior change model on returning to opium addiction among women of reproductive age
Public title
Effect of motivational interviewing-based behavior change model on returning to opium addiction among women of reproductive age
Purpose
Treatment
Inclusion/Exclusion criteria
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
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
Ghazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd.
City
Qazvin
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.Qums.REC.1396.120

Health conditions studied

1

Description of health condition studied
substance abuse
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances

Primary outcomes

1

Description
The rate of return to re-use of drugs is evaluated before and after the intervention.
Timepoint
2 months after the intervention and one after the end of the intervention
Method of measurement
Return Prediction scale

Secondary outcomes

empty

Intervention groups

1

Description
Beside the usual medical cares for quit the addiction , The Intervention Group will participate in 8 Session motivational interviews (60minutes per each session ) and their rate of motivation for return to drugs will be measured before and after the inter
Category
Treatment - Other

2

Description
. Control Group will not Participate in this sessions and take usual medical care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
S
Full name of responsible person
ELHAM BABAEI POUR
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences - Vice chancellor of research
Full name of responsible person
Dr. Peymani
Street address
Bahonar Blvd.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences - Vice chancellor of research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ghazvin University of Medical Sciences
Full name of responsible person
Sonia oveisi
Position
Phd-Maternal and child health
Other areas of specialty/work
Street address
Bahonar Blvd.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
soveisi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghazvin University of Medical Sciences
Full name of responsible person
Sonia oveisi
Position
phd- Maternal and child health
Other areas of specialty/work
Street address
Bahonar Blvd.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
soveisi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 28 3333 6001
Fax
Email
soveisi@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...