Effectiveness of coping techniques on self-efficacy and craving in Methamphetamine – dependent patients
Design
The present study is a Blind Clinical Trial. that 80 persons will be selected and randomly assigned in two groups (40 to experimental and 40 to control group).
Settings and conduct
The statistical population will include all Methamphetamine – dependent women referred to Farabi hospital in Kermanshah, that 80 persons will selected in available method and randomly allocated in two groups (40 in experiment a 40 in control groups) Both experiment and control group members will complete craving questionnaire(DDQ), Desire for drug Questionnaires self –efficacy at the beginning of the study. The experiment will receive educations related to craving coping techniques in 8 one hour and a half session afterwards while control group will not. In the end of study (two months later). Questionnaires of craving, self-efficacy and Relapse will be compared. For ethical considerations, the control group will also be trained the coping techniques after the study is finished.
Participants/Inclusion and exclusion criteria
Inclusion criteria are female gender; diagnosis of Methamphetamine – dependence based on DSM-V in participants.
Intervention groups
Intervention group: The experiment will receive coping techniques in 8 one hour and a half session afterwards.
Main outcome variables
self-efficacy; craving
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038813N1
Registration date:2018-03-09, 1396/12/18
Registration timing:registered_while_recruiting
Last update:2018-03-09, 1396/12/18
Update count:0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
Nasrin Abdoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 4513
Email address
nasrin.abdoli@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Coping Techniques on craving and self –efficacy in Methamphetamine users
Public title
The Effect of Coping Techniques on craving and self –efficacy in Methamphetamine Abusers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female gender; diagnosis of Methamphetamine – dependence based on DSM-V in participants; a minimum of six Months dominantly Methamphetamine abuse and not being afflicted with other serious Psychiatric disorders
Exclusion criteria:
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
کمیته اخلاق دانشگاه علوم پزشکی کرمانشاه
Street address
Building No.2, Shahid Beheshti,Vice Chancellor for Research Affairs Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Approval date
2017-09-26, 1396/07/04
Ethics committee reference number
IR.KUMS.REC.1396.346
Health conditions studied
1
Description of health condition studied
Methamphetamine dependence
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
self-efficacy
Timepoint
The beginning of the study and end of the study(week eight)
Method of measurement
Based on the Self-efficacy questionnaire (GAS)
2
Description
craving
Timepoint
The beginning of the study and end of the study(week eight)
Method of measurement
Based on thecraving questionnaire(DDQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experiment will receive coping techniques in 8 one hour and a half session afterwards.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Jalal Shakeri
Street address
Isar square, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 4513
Email
jshakeri_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2,Shahid Beheshti,Vice Chancellor for Research Affairs Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3836 0014
Email
khamzehee@kums.ac.ir
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
Nasrin
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isar square, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83382610700
Email
nasrinabdoli511@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Vahid Farnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isar square, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 4513
Email
Vfarnia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Abdoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isar square, Farabi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 1046
Email
abdolinasrin511@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
I have no plans at this time
When the data will become available and for how long
I have no plans at this time
To whom data/document is available
I have no plans at this time
Under which criteria data/document could be used
I have no plans at this time
From where data/document is obtainable
I have no plans at this time
What processes are involved for a request to access data/document