Protocol summary

Summary
Objectives: comparison of effect of anger management training by workshop method and training package on aggressive clients referred to the addiction withdrawal clinic of psychiatric hospitals in Mashhad Design: this randomized clinical trial will be performed on 60 clients referred to the addiction withdrawal clinics of Hejazi and Ibn Sina psychiatric hospitals of Mashhad in three workshop, training package and control group Methodology: In the workshop group, participants will participate in four two - hour sessions over 2 days for anger management training every other day and the training package group will participate in anger management training with booklet and compact disc simultaneously. And control group will not receive any interference. Major eligibility criteria for participants: At least high school level, male, no problem in hearing and speech, lack of use of other forms of addiction withdrawal, not experience major stress at least for 6 months, Buss and Perry Aggression Questionnaire above 75 Major criteria for no eligibility: absence in more than 20% of workshop sessions (in the workshop), non performance of duties or respond to researcher follow up in training package group Intervention: workshop, training package Main outcome measures (variables): aggression will be measured immediately before and one month after the intervention by Buss and Perry Aggression Questionnaire

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120925250N2
Registration date: 2016-01-09, 1394/10/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Saeed Vaghee
Name of organization / entity
Mashhad university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
vaghee@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2013-11-06, 1392/08/15
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of anger management training by workshop and training package and control (without intervention) methods on aggressive clients referred to the addiction withdrawal clinic of psychiatric hospitals in Mashhad
Public title
Comparison of effect of anger management training by workshop method and training package on aggressive clients referred to the addiction withdrawal clinic
Purpose
Other
Inclusion/Exclusion criteria
Major eligibility criteria for participants: at least high school level, male, no problem in hearing and speech, lack of use of other forms of addiction withdrawal, not experience of major stress at least for 6 months, Buss and Perry Aggression Questionnaire score above 75 Major criteria for no eligibility: absence in more than 20% of workshop sessions (in the workshop), Non performance of duties or respond to researcher follow up in training package group
Age
From 20 years old to 60 years old
Gender
Male
Phase
2-3
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
Participants were randomly assigned to three groups based on a visit to the addiction withdrawal clinic of Hejazi and Ibn Sina psychiatric hospitals in Mashhad

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Vice chancellor for research, Mashhad university of medical sciences, next to the Hovezeh cinema, Daneshgah street, Mashhad
City
Mashhad
Postal code
9177899191
Approval date
2013-10-23, 1392/08/01
Ethics committee reference number
research/921035/1/432

Health conditions studied

1

Description of health condition studied
Clients referred to the addiction withdrawal clinic
ICD-10 code
F10, F11,
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use

Primary outcomes

1

Description
Aggression
Timepoint
Immediately before and one month after the intervention
Method of measurement
Buss and Perry aggression questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Anger management workshop: participants will be underwent Anger management training by workshop method in four two- hour sessions during 2 days for every other day
Category
Behavior

2

Description
Anger management training package: participants will be underwent anger management training by booklet and compact disc
Category
Behavior

3

Description
control group will not receive any interference
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina psychiatric hospital, Mashhad
Full name of responsible person
Dr Fateme Mohareri
Street address
Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad university of Medical sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad university of medical sciences, next to the Hovezeh Cinema, Daneshgah street, Mashhad
City
Mashhad
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
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
Mashhad university of medical sciences
Full name of responsible person
Saeed Vaghee
Position
Instructor of psychiatric nursing
Other areas of specialty/work
Street address
Rudaki avenue, Reza Shahr region, Mashhad
City
Mashhad
Postal code
9317744839
Phone
+98 51 3879 8881
Fax
Email
Vaghees@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Saeed Vaghee
Position
Instructor of psychiatric nursing
Other areas of specialty/work
Street address
Rudaki avenue, Reza Shahr region, Mashhad
City
Mashhad
Postal code
9317744839
Phone
+98 51 3879 8881
Fax
Email
Vaghees@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Saeed Vaghee
Position
Instructor of psychiatric nursing
Other areas of specialty/work
Street address
Rudaki avenue, Reza Shahr region, Mashhad
City
Mashhad
Postal code
9317744839
Phone
+98 51 3879 8881
Fax
Email
Vaghees@mums.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
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