Protocol summary

Study aim
Investigating the effectiveness of cognitive-analytical therapy on improving the symptoms of Antisocial Personality Disorder.
Design
The sample size in this research is at maximum, 40 people, who will be distributed into intervention and control groups by simple randomization, and the research has been designed as a pre-test-post-test design with a control group and in the Single blind manner .
Settings and conduct
This research will held in one of the prisons of the country. First, two hundred Milon Inventories, will be taken so that sample people are identified; Then they will be randomly placed in the intervention and contro groups; Then, questionnaires related to the research variables will be taken; Then the 10 session protocol of cognitive-analytic therapy will be applied on the intervention group. Finally, questionnaires measuring research variables will be collected again from the members of both groups and the results will be analyzed.
Participants/Inclusion and exclusion criteria
The participants in this research will be the prisoners with antisocial personality disorder. The condition for entering this research is to obtain scores of antisocial personality disorder. The main conditions for Not entering the study before randomization will be: 1) Non cooperation and participation of the participants. 2) Not being able to read, write, hear and speak.
Intervention groups
In the intervention group, 10 session protocol of cognitive-analytic therapy will be applied. In the control group, no protocol will be applied.
Main outcome variables
1) Scores obtained in the Psychological Inventory of Ego Strength. 2) Scores obtained in the NEO Inventory (60 questions short form). 3) Scores obtained in the communication skills assessment inventory.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240212060971N1
Registration date: 2024-07-08, 1403/04/18
Registration timing: prospective

Last update: 2024-07-08, 1403/04/18
Update count: 0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Mohammad Ali NajmZaadeh
Name of organization / entity
The University of Khatam
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0368
Email address
m.najmzadeh@khatam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of cognitive-analytical therapy on the level of ego empowerment, emotional stability and communication skills in prisoners with antisocial personality disorder.
Public title
Investigating the effectiveness of cognitive-analytical therapy on personality disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The condition for entering this research is to obtain scores above the cut-off line in the Indicators related to Antisocial Personality Disorder in Milon's Clinical Multi-axis Inventory, the fourth edition (MCMI-4).
Exclusion criteria:
Being non cooperative at the part of participants in the process of taking the Milon's Clinical Inventory. Not having reading and writing literacy and not having a healthy sense of hearing and the ability to speak.
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to Intervention and Control groups will be done using the "lottery method"; also The randomization method will be "simple randomization" and the randomization unit will be "individual." The description of the procedure is so that: Before taking Milon's multi-axis clinical inventory, the fourth edition, each participant will be randomly assigned to a number between 1 to 200. After taking the inventory and going through the The process of reviewing answer sheets, inevitably, people with Antisocial Personality Disorder will be identified; Therefore, in the following, the researcher, without paying attention to any other variable, such as surname, name, age, ethnicity, or the crime committed, and based only on the random numbers previously assigned to each of the participants, will execute the distribution of randomly identified people to intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants: Before the application of the therapeutic protocol of the interventions; they (Participants) will only be told in general that: "In case of participation and cooperation, they will benefit from 10 free counseling sessions", and only specialized informations will not be provided to them; But it is obvious that after the beginning of therapeutic interventions, the participants spontaneously will be informed about the measures being applied in the process of "implementing the interventions". Data analysts: They will also be unaware of the possible results in question, and in this order, without knowing exactly what results they should be looking for, they will only analyze the data.
Placebo
Used
Assignment
Single
Other design features
This study (research), considering the 10 sessions therapeutic protocol of cognitive-analytic therapy which has been adjusted specifically for this research and its validity has been confirmed by 3 psychotherapy specialists & is classified in the category of short-term interventions (treatments), in terms of the depth of the interventions in contrast to the duration of the interventions, is a very excellent and distinct candidate for providing counseling and psychotherapy services to the general public who either do not have access to these services at all or cannot afford the costs related to these services for any reason.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University.
Street address
Shahid Shahriari Square, Evin, Tehran.
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2024-01-28, 1402/11/08
Ethics committee reference number
IR.SBU.REC.1402.160

Health conditions studied

1

Description of health condition studied
Antisocial Personality Disorder
ICD-10 code
F60.2
ICD-10 code description
Antisocial Personality Disorder

Primary outcomes

1

Description
The level Ego strengths, which is approximately the ability of a person to manage her/his self when faced with adversity.
Timepoint
Before and after the interventions.
Method of measurement
In order to measure this variable, Psychological Inventory of Ego Strength (PIES) will be used. This Inventory has 64 questions and statements are graded on a 5-degree Likert scale. The highest score a person can get is 300 and the lowest score is 60. A high score in this test means a high level of ego competence.

Secondary outcomes

1

Description
Emotional stability, which is almost a person's ability to maintain a cool head when faced with extreme exciting situations.
Timepoint
Before and after the interventions.
Method of measurement
In order to measure the emotional stability of the subject, the individual's score in the neuroticism index (psychopath) in the questionnaire of the big five factors of personality traits; Neo; The short form of 60 questions is considered in reverse, meaning that the higher the score in this index, the lower the emotional stability and vice versa.

2

Description
Communication skills, which are the ability of a person to establish and maintain effective interpersonal communication.
Timepoint
Before and after the interventions.
Method of measurement
In order to measure communication skills, a questionnaire is used as a "communication skills test". The scoring of each question varies from one to five. In reverse questions, scoring will also be done in reverse. Finally, the total score is obtained from the sum of the scores.

Intervention groups

1

Description
Intervention group: Cognitive-analytical intervention in one sentence is "discussions at the unconscious level". These interventions will take place in the form of applying the 10-session cognitive-analytical therapy protocol that have been readjusted specifically for this research and its validity has been confirmed by 3 psychotherapy specialists. Cognitive-analytic therapy is classified in the category of short-term therapies. Counseling and psychotherapy sessions will be held twice a week, at least one day apart, for approximately 2 hours. The summary of the 10-session instruction of the current research is as follows: Session 1: Introduction to CAT and Assessment; Session 2: Psychoeducation and Formation of Therapeutic Alliance; Session 3: Identifying Problematic Patterns and their Origins With the use of "Reformulation process"; Session 4: Understanding Relationships and Their Impact on ASPD; Session 5: Building Awareness of Triggers and Consequences; Session 6: Enhancing Ego Empowerment; Session 7: Improving Emotional Stability; Session 8: Developing Communication Skills; Session 9: Review Progress and Revise Strategies if Needed; Session 10: Closure and Future Planning.
Category
Treatment - Other

2

Description
Control group: The intervention in this group is such that No type of Psychotherapy will be applied, either with or without a protocol. The members of this group will only be told that they will be on A waiting list to receive counseling and psychotherapy services.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
One of the prisons under the supervision of the Country's Prison Affairs Organization
Full name of responsible person
Mohammad Ali NajmZa^deh
Street address
General Directorate of Tehran Province's Prisons, Next to the country's prisons organization, At the beginning of Fara^z Kouy, Saa^dat A^ba^d, Tehran.
City
Tehran
Province
Tehran
Postal code
1396934537
Phone
+98 21 2212 3065
Fax
+98 21 2212 2700
Email
a7.najm@gmail.com
Web page address
https://www.prisons.ir/service/Provinces/tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Khatam
Full name of responsible person
Mr. Dr. Shariat, Honorable Vice-Chancellor for Education and Research
Street address
Hakim Azam Building: Khatam University, No. 30, Hakim Azam St., North Shiraz St., Molla Sadra Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 4500
Fax
+98 21 8917 4500
Email
M.Hashemi2@Khatam.ac.ir
Web page address
https://khatam.ac.ir/
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Khatam
Proportion provided by this source
100
Public or private sector
Private
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
The University of Khatam
Full name of responsible person
Mohammad Ali NajmZaadeh
Position
Master's degree student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Khatam University, Hakim Azam Building, No. 30, Hakim Azam St., North Shiraz St., Molla Sadra Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 4500
Fax
Email
m.najmzadeh@khatam.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Khatam
Full name of responsible person
Mohammad Ali NajmZaadeh
Position
Master's degree student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Khatam University, Hakim Azam Building, No. 30, Hakim Azam St., North Shiraz St., Molla Sadra Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 4500
Fax
Email
m.najmzadeh@khatam.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Khatam
Full name of responsible person
Mohammad Ali NajmZaadeh
Position
Master's degree student in Clinical Psychology.
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Khatam University, Hakim Azam Building, No. 30, Hakim Azam St., North Shiraz St., Molla Sadra Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1991633357
Phone
+98 21 8917 4500
Fax
Email
m.najmzadeh@khatam.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The purpose of this research is to investigate the effectiveness of cognitive-analytical psychotherapy instruction (protocol) on alleviating the symptoms of Antisocial Personality Disorder, and the researcher will reveal & share all of the data, documentations and results of this research with the general audience. Obviously, this sharing will in no way negate the principle of protection and preservation of participants's personal information. It is also worth mentioning that the publication of all or part of the data, documentations, results and the method of information analysis will be subject to the permission of the Prison Affairs Organization of the country.
When the data will become available and for how long
From September 22, 2024 onwards and after the issuance of the necessary permissions by the Prison Affairs Organization of the country.
To whom data/document is available
After issuing the necessary permits from the country's prison affairs organization, All special and general audiences and all interested people will have permission to access all of the data, documents and research results. Also, curious audiences can communicate with the researcher digitally or even in person in order to get more information.
Under which criteria data/document could be used
1) The intention and purpose of the person requesting the data, documentations, method of analysis and results must be identified. 2) Issuance of necessary permits by the Prison Affairs Organization of the country. 3) Obtaining the written and legally traceable consent of the researchers regarding the preservation of the intellectual property rights of the data, documentations, method of analysis and results.
From where data/document is obtainable
Although after the issuance of the necessary permits by the Prison Affairs Organization of the country, all or part of the data, documents and results of this research will be available to the public in the form of extracted articles, curious audiences can send their requests to the researcher's personal email address, which is: a7.najm@gmail.com.
What processes are involved for a request to access data/document
The process of receiving the requested information is such that after receiving the email from the applicant, the researcher will study the information they is considering and send the requested items as soon as possible. This period of time will be at maximum of one Month.
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