Protocol summary

Study aim
The effectiveness of schema therapy on antisocial behavior, emotion regulation and psychological well-being of female prisoners.
Design
"This is a parallel-group clinical trial with two arms (intervention and control). Participants were randomly assigned to the groups. The sample size consists of 30 participants, with 15 in the intervention group and 15 in the control group."
Settings and conduct
This study was conducted in Shahrekord women's prison. The intervention consisted of schema therapy sessions conducted by a psychologist, It was also unblinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having appropriate psychological insight, agreeing to participate in the research, not receiving any other treatment program, and remaining at least 2 months out of prison. Exclusion criteria: more than 2 absences, not doing homework, being in solitary confinement or being transferred to another prison.
Intervention groups
"The intervention group will undergo schema therapy over 10 weekly sessions, while the control group will not receive any psychological treatment."
Main outcome variables
Schema therapy; Antisocial behaviors; Emotion regulation; Psychological well-being; Imprisoned women.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240908062982N1
Registration date: 2024-09-28, 1403/07/07
Registration timing: retrospective

Last update: 2024-09-28, 1403/07/07
Update count: 0
Registration date
2024-09-28, 1403/07/07
Registrant information
Name
Farima Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3228 4492
Email address
info @ iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-01-19, 1402/10/29
Actual recruitment start date
2023-11-06, 1402/08/15
Actual recruitment end date
2024-01-19, 1402/10/29
Trial completion date
2024-02-29, 1402/12/10
Scientific title
The effectiveness of schema therapy on antisocial behavior, emotion regulation and psychological well-being of female prisoners
Public title
The effectiveness of schema therapy on the behavior and psyche of female prisoners
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having proper psychological insight Patient consent to participate in the research Not receiving any other training or treatment program At least 2 months of their imprisonment are left Regular participation in therapy sessions
Exclusion criteria:
Absent more than 2 sessions Not doing homework People who were in solitary confinement Transfer to another prison or early release
Age
No age limit
Gender
Female
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)
Not 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
Ethics Committee of Islamic Azad University, Najafabad branch
Street address
University of Najafabad, Imam Khomeini Blvd
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2024-04-25, 1403/02/06
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1403.048

Health conditions studied

1

Description of health condition studied
Antisocial Behavior, Emotion Regulation, Psychological Well-being
ICD-10 code
6D10.Z
ICD-10 code description
اختلال شخصیت ضداجتماعی

Primary outcomes

1

Description
The primary outcome variable is the score of antisocial behaviors, which is measured using the Robinson and O'Leary-Kelly Antisocial Behavior Questionnaire. Changes in the score will be evaluated before and after the intervention to assess the effectiveness of schema therapy.
Timepoint
The measurement of outcome variables will be conducted at two time points: before the intervention (at the beginning of the study) and after the completion of therapy sessions (following 10 weekly sessions).
Method of measurement
The measurement of the score of antisocial behaviors is conducted using the Robinson and O'Leary-Kelly Antisocial Behavior Questionnaire

2

Description
Emotion Regulation Score: This variable is measured using the Cognitive Emotion Regulation Questionnaire (CERQ) developed by Garnefski and Kraaij. Changes in the score are assessed before and after the therapeutic intervention.
Timepoint
The emotion regulation score will be measured at two time points: before the intervention (at the beginning of the study) and after the completion of therapy sessions (following 10 weekly sessions).
Method of measurement
The emotion regulation score will be measured using the Garnefski and Kraaij’s Cognitive Emotion Regulation Questionnaire (CERQ).

3

Description
"Psychological well-being is measured using the Ryff Psychological Well-being Questionnaire. Changes in the scores of this questionnaire will be examined before and after the therapeutic intervention."
Timepoint
"Psychological well-being scores are measured at two time points: before the intervention (at the beginning of the study) and after the completion of the therapy sessions (following 10 weekly sessions)."
Method of measurement
"The Ryff Psychological Well-being Questionnaire is used to assess psychological well-being scores."

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in this group will receive schema therapy. The intervention consists of 10 weekly sessions, each lasting 90 minutes, conducted by a trained psychologist. These sessions are designed based on Young's schema therapy model and focus on identifying maladaptive schemas, restructuring thought patterns, and enhancing emotion regulation strategies.
Category
Behavior

2

Description
Control group: The control group will not receive any intervention and will only serve as a baseline comparison to evaluate the effects of schema therapy in the intervention group. Their scores on psychological well-being, emotional regulation, and antisocial behavior will be measured at the start and after the completion of the therapeutic sessions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Central Prison of Shahrekord
Full name of responsible person
Hamidreza Heydari
Street address
Sarvestan 3 St., Kooshesh Sharghi St., Sanat St., Sanat Industrial Hub, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۶۵۷۳۷۶
Phone
+98 38 3242 8832
Fax
+98 38 3334 5966
Email
ch-ba@bonyadtaavon.org

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezo Vasili
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Esfahan
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4223 2873
Email
info @ iaun.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Farima Fathi
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 2 , Second Floor., Next to Building Rose., End of Tohid Street., Gudal Cheshmeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815755153
Phone
+98 38 3228 4492
Email
psyfathii@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farima Fathi
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 2 , Second Floor., Next to Building Rose., End of Tohid Street., Gudal Cheshmeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815755153
Phone
+98 38 3228 4492
Email
psyfathii@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farima Fathi
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 2, Second Floor, Next to Rose Building, End of Tohid St., Goudal Cheshmeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815755153
Phone
+98 38 3228 4492
Email
psyfathii@gmail.com

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
"Effectiveness of Schema Therapy on Antisocial Behavior, Emotion Regulation, and Psychological Well-being of Female Prisoners." The dataset includes anonymized participant data, focusing on key outcome measures such as antisocial behavior, emotion regulation, and psychological well-being. The dataset is derived from standardized questionnaires like Ryff's Psychological Well-being (2002), the Robinson & O’Leary-Kelly Antisocial Behavior Scale (1998), and the Garnefski & Kraaij Cognitive Emotion Regulation Questionnaire (2006).
When the data will become available and for how long
the dataset will be accessible starting six months after the publication of the research results. Access will remain open for a period of two years.
To whom data/document is available
the dataset will be available to academic researchers affiliated with universities and research institutions. Requests from researchers in non-academic sectors will be evaluated on a case-by-case basis.
Under which criteria data/document could be used
the dataset is provided for academic research purposes, such as replication of results, meta-analysis, and further studies on the effectiveness of schema therapy. Usage must comply with data protection regulations, and no attempt to re-identify participants is allowed.
From where data/document is obtainable
Name: Abbas Mokhtari Email: Mokhtari_20001@yahoo.com Phone Number: +98 9132894600 Name: Farima Fathi Hafshejani Email: psyfathii@gmail.com Phone Number: +98 9100865650
What processes are involved for a request to access data/document
Requests for data access will be reviewed within 30 days. Approved applicants will receive a data-sharing agreement, outlining the terms and conditions for using the dataset. Upon signing, the dataset will be made available.
Comments
No additional fees will be charged for data access. Researchers are encouraged to cite the dataset in any publications resulting from its use.
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