Protocol summary

Study aim
Investigation of Psychodrama on Emotion Regulation, Assertiveness and Crime Reduction in Antisocial Personality Disorder
Design
Clinical trial with a sample size of 30 patients, pre-test and post-test design with control group, unblinded, simple randomization, phase 1 on the experimental group of 15 people, lottery method was used for simple randomization.
Settings and conduct
After conducting the pre-test for both groups, for the experimental group, psychodrama therapy sessions were conducted in 12 sessions 90 minutes for 6 weeks in a group manner and with a sequence of two sessions per week.
Participants/Inclusion and exclusion criteria
Having the criteria of Antisocial Personality Disorder
Intervention groups
We have an experimental group consisting of 15 participants and a control group consisting of 15 participants. In order to check the effectiveness of psychodrama, we performed the process of treatment and intervention using psychodrama sessions on the members of the experimental group, and no treatment sessions were held for the control group, so that the difference between the two groups could be compared based on the results.
Main outcome variables
Emotion regulation, Assertiveness and Crime Reduction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221218056855N1
Registration date: 2023-02-08, 1401/11/19
Registration timing: retrospective

Last update: 2023-02-08, 1401/11/19
Update count: 0
Registration date
2023-02-08, 1401/11/19
Registrant information
Name
Soghra Javanbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 7793
Email address
soori.javanbakht27@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-01, 1401/02/11
Expected recruitment end date
2022-05-02, 1401/02/12
Actual recruitment start date
2022-05-01, 1401/02/11
Actual recruitment end date
2022-05-02, 1401/02/12
Trial completion date
2022-07-03, 1401/04/12
Scientific title
Investigation of Psychodrama on Emotion Regulation, Assertiveness and Crime Reduction in Anti-Social Personality Disorder
Public title
Effectiveness of Psychodrama on Antisocial Personality Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the criteria of Antisocial Personality Disorder
Exclusion criteria:
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In the selection of the sample, a simple random method was used. First, each name was given a number, then they wrote that number on a piece of paper and put the closed papers in a plate. Finally, each time one of the papers was randomly removed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Islamic Azad University
Street address
Golestan Highway, Farhang Shahr, Main Blvd., Ahvaz Branch Islamic Azad University
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2022-05-08, 1401/02/18
Ethics committee reference number
IR.IAU.AHVAZ.REC.1401.069

Health conditions studied

1

Description of health condition studied
Antisocial Personality Disorder
ICD-10 code
F60-F69
ICD-10 code description
Disorders of adult personality and behaviour

Primary outcomes

1

Description
People with antisocial personality disorder
Timepoint
Before and after therapeutic intervention
Method of measurement
Clinical diagnostic interview based on DSM-5 criteria

Secondary outcomes

1

Description
Emotion Regulation
Timepoint
Before and after therapeutic intervention
Method of measurement
Victor and Klonsky scale of difficulty in emotion regulation

2

Description
Assertiveness
Timepoint
Before and after therapeutic intervention
Method of measurement
Herzberger et al Assertiveness questionnaire

3

Description
Crime Reduction
Timepoint
Before and after therapeutic intervention
Method of measurement
Fazli questionnaire to measure attitudes towards delinquent Behaviors

Intervention groups

1

Description
Intervention group: Psychodrama treatment sessions for the experimental group were conducted in 12 90-minute sessions for 6 weeks in a group manner and with a sequence of two sessions per week at Ahvaz Correctional Center. Psychodrama sessions include emotion regulation, self-expression and crime reduction. The plan of treatment sessions was based on the book Drama Therapy (Amrai) and Psychodrama (Fathi). At first, familiarization of the group and creation of trust and confidentiality, an overview of the goals and roles, time and structure and rules of the therapy sessions were stated. Then expressing the childhood memories of the members, choosing the first person and performing the memory by the patient, and in the continuation of the sessions, using psychodrama techniques to enter into the main problems of the people and address the variables of treatment and participation of the members. Finally, summing up the meetings and announcing the end of the group and saying goodbye.
Category
Treatment - Other

2

Description
Control group: There was no treatment for this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Correctional Center
Full name of responsible person
Dr Shahrokh Valizadeh
Street address
Sepidar Ave
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 916 305 0846
Email
shahrokh.va@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Reza Johari fard
Street address
Golestan Highway, Farhang Shahr, Islamic Azad University Ahvaz branch
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 913 317 0542
Email
rjoharifard@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Reza Joharifard
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Farhang Shahr Ave.
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 913 317 0542
Email
rjoharifard@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Reza Joharifard
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Highway, Farhang Shahr, Islamic Azad University Ahvaz branch
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 913 317 0542
Email
rjoharifard@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soghra Javanbakht
Position
Master Graduate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kian Abad, Arvand Blvd., West Sepehari St.
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 916 804 2678
Email
soori.javanbakht27@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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