Protocol summary

Summary
The aim of current study is the effectiveness of cognitive-behavioral group therapy on promoting of mental health in opioid addicts. This study is a pretest- posttest study with control group. The research community is all of opioid addicts in Kermanshah city and the required sample is 36 opioid addicts. After convenience sampling, the subjects are randomly divided into two groups: cognitive behavior therapy (18 person) and control groups(18 person). Data are collected with general health questionnaire at baseline and post-test and one month after the end of treatment

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010325817N1
Registration date: 2016-01-20, 1394/10/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-20, 1394/10/30
Registrant information
Name
Ali Akbar Parvizi Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 330 8692
Email address
aa.parvizif@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Science
Expected recruitment start date
2014-09-29, 1393/07/07
Expected recruitment end date
2015-09-29, 1394/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cognitive - Behavioral Group therapy in promotion of mental health in opiate addicts
Public title
Effect of Cognitive - Behavioral Group therapy in promotion of mental health in opiate addicts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: Having at least a high school diploma ; Non-use of psychiatric medications or other treatment before or during the intervention Exclusion criteria include: The presence of significant psychiatric disorder ; Thoughts of suicide
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
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
Kermanshah University of Medical Science
Street address
Vice – Chancellery of Research & Technology Affairs, building No.2,shahid beheshti blvd, Kermanshah
City
Kermanshah
Postal code
6715847141
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
KUMS.Res.1394.167

Health conditions studied

1

Description of health condition studied
Mental and behavioural disorders due to use of opioids
ICD-10 code
f11
ICD-10 code description
Mental and behavioural disorders due to use of opioids

Primary outcomes

1

Description
Mental health
Timepoint
befor intervention, tree month after intervention and one month after end of intervention
Method of measurement
general health questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group received 12 sessions(90 minutes) of cognitive behavioral therapy
Category
Behavior

2

Description
the control group will received only routine treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital of Kermanshah
Full name of responsible person
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Dr. Hamze
Street address
Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Science
City
Kermanshah
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 Science
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
Kermanshah University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Ahmadi
Position
post graduate
Other areas of specialty/work
Street address
Farabi Educational hospital, Dowlat Abad st., Isar square, Kermanshah
City
Kermanshah
Postal code
Phone
+98 917 344 2881
Fax
Email
mojtabakmahmadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Aliakbar Parvizi Fard
Position
phd
Other areas of specialty/work
Street address
Farabi Educational hospital, Dowlat Abad st., Isar square, Kermanshah
City
Kermanshah
Postal code
Phone
+98 918 330 8692
Fax
Email
aa.parvizif@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azade Barzkar
Position
Other areas of specialty/work
Street address
City
Kermansha
Postal code
Phone
00
Fax
Email
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
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