Protocol summary

Study aim
The aim of this study is to investigate the effectiveness of cognitive behavior therapy (CBT) on reducing feelings of shame/guilt, improving self-esteem, and decreasing suicidal ideation among women who are victims of violence.
Design
Experimental Design (pre- and post test)
Settings and conduct
Shelter home ,NGOs
Participants/Inclusion and exclusion criteria
The terms inclusion and exclusion criteria relate to the makings that research participants must have to be considered for Participation and those that would rule them out. Women who meet the following criteria would be eligible to participate in research examining the effects of cognitive behavior therapy on shame/guilt, self-esteem, and suicidal thoughts among survivors of domestic abuse. Women, Participation in therapy, being over 18, having endured physical, sexual, or emotional abuse at some point of shame/guilt, low self-esteem, and suicidal ideation. While exclusion criteria refer to the characteristics that would disqualify someone from participating in the study, male and children,
Intervention groups
Experimental Group
Main outcome variables
Shame, guilt, low self-esteem, and suicidal ideation

General information

Reason for update
Acronym
"CBT", which stands for "Cognitive Behavior Therapy." Cognitive behavior therapy is a type of psychotherapy that focuses on helping individuals change their negative thought patterns and behaviors to improve their mental health and well-being.
IRCT registration information
IRCT registration number: IRCT20230416057930N1
Registration date: 2023-04-30, 1402/02/10
Registration timing: retrospective

Last update: 2023-04-30, 1402/02/10
Update count: 0
Registration date
2023-04-30, 1402/02/10
Registrant information
Name
Noor Alam
Name of organization / entity
Country
Pakistan
Phone
+92 306 4867569
Email address
noormustafa0321@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-28, 1402/02/08
Expected recruitment end date
2023-04-28, 1402/02/08
Actual recruitment start date
2023-04-28, 1402/02/08
Actual recruitment end date
2023-04-28, 1402/02/08
Trial completion date
2023-04-28, 1402/02/08
Scientific title
Effectiveness of Cognitive Behavior Therapy on Shame/Guilt, Self- Esteem and Suicidal Ideation among Women Victims of Violence
Public title
Effectiveness of Cognitive Behavior Therapy on Shame/Guilt, Self- Esteem and Suicidal Ideation among Women Victims of Violence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The terms inclusion and exclusion criteria relate to the makings that research participants must have to be considered for Participation and those that would rule them out. Women who meet the following criteria would be eligible to participate in research examining the effects of cognitive behavior therapy on shame/guilt, self-esteem, and suicidal thoughts among survivors of domestic abuse. Women, Participation in therapy, being over 18, having endured physical, sexual, or emotional abuse at some point of shame/guilt, low self-esteem, and suicidal ideation.
Exclusion criteria:
While exclusion criteria refer to the characteristics that would disqualify someone from participating in the study, male and children,
Age
From 20 years old to 50 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is an essential part of research design in order to ensure that the results obtained from a study are valid and reliable. Randomization refers to the process of randomly assigning participants to different groups in a study, such as a treatment group or a control group, to minimize the effects of any potential confounding variables.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
experimental pre and post test

Secondary Ids

1

Registry name
Iranian
Secondary trial Id
69809
Registration date
2023-04-28, 1402/02/08

Ethics committees

1

Ethics committee
Name of ethics committee
islamia university of Bahawalpur
Street address
Islamia university of Bahawalpur aisha hall
City
Bahawalpur
Postal code
The postal code for
Approval date
2023-04-28, 1402/02/08
Ethics committee reference number
2060/A

Health conditions studied

1

Description of health condition studied
shame, guilt, low self-esteem, and suicidal ideation among victims of violence
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Decreed shame /guilt and suicidal ideation and increased self-esteem
Timepoint
45 minutes
Method of measurement
Guilt / Shame Proneness Scale (GASP) The Rosenberg Self‐esteem Scale (Rosenberg, 1965). Beck Scale for Suicidal Ideation

Secondary outcomes

1

Description
CBT can be a highly effective treatment for women who have experienced violence and are struggling with shame and guilt, low self-esteem, and suicidal ideation. However, it is important to note that every individual's experience and needs are unique, and treatment should be tailored to meet the specific needs of each individual.
Timepoint
Culturally adapted cognitive behavioral therapy (CaCBT) using a manual named باسط کی کہانی was Victims of Violence" Self-help guidance As individual therapy over the duration of two months (once per week),
Method of measurement
Informed ConsentGuilt / Shame Proneness Scale (GASP) (Cohen et al., 2011).The Rosenberg Self‐esteem Scale (Rosenberg, 1965).Beck Scale for Suicidal Ideation (BSSI) (Beck & Steer, 1988).

Intervention groups

1

Description
Intervention groups: experimental and control groupsIn the second phase of the study, after that pre-test (screening), the sample was divided into two groups (experimental and control groups). This study aimed to investigate the effectiveness of cognitive behavior therapy in managing emotional problems, shame/guilt, self-esteem, and suicidal ideation among women victims of violence. A pre-test and post-test experimental research design with a control group was used, and 50 participants were randomly assigned to either the experimental or control group (n = 25 each).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
islamia university of Bahawalpur
Full name of responsible person
islamia university of Bahawalpur
Street address
Islamia university of Bahawalpur aisha hall
City
Bahawalpur
Postal code
The postal code for
Phone
+92 306 4867569
Email
noormustafao321@gmail.com
Web page address
https://www.google.com/.

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
islamia university of Bahawalpur
Street address
Islamia university of Bahawalpur aisha hall
City
Bahawalpur
Postal code
The postal code for
Phone
+92 306 4867569
Email
noormustafa0321@gmail.com
Web page address
https://www.google.com/.
Grant name
supporting study
Grant code / Reference number
2060/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Effectiveness of Cognitive Behavior Therapy on Shame/Guilt, Self- Esteem and Suicidal Ideation among Women Victims of Violence
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
Iran University of Medical Sciences
Full name of responsible person
islamia university of Bahawalpur
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamia university of Bahawalpur aisha hall
City
Bahawalpur
Province
punjab
Postal code
The postal code for
Phone
+92 306 4867569
Email
noormustafa0321@gmail.com
Web page address
https://www.google.com/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
islamia university of Bahawalpur
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamia university of Bahawalpur aisha hall
City
Bahawalpur
Province
punjab
Postal code
The postal code for
Phone
+92 306 4867569
Email
noormustafa0321@gmail.com
Web page address
https://www.google.com/

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Noor Alam
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamia university of Bahawalpur aisha hall
City
Bahawalpur
Province
punjab
Postal code
The postal code for
Phone
+92 306 4867569
Email
noormustafa0321@gmail.com
Web page address
https://www..com/page.

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The decision to share individual participant data (IPD) in a study on the effectiveness of cognitive behavior therapy (CBT) on shame/guilt, self-esteem, and suicidal ideation among women victims of violence depends on several factors, including ethical considerations, legal requirements, and resource limitations.
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
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effectiveness of Cognitive Behavior Therapy on Shame/Guilt, Self- Esteem and Suicidal Ideation among Women Victims of Violence
When the data will become available and for how long
In general, data availability and duration depend on a variety of factors, including the nature of the data, the organization responsible for collecting or providing the data, and any relevant laws or regulations
To whom data/document is available
It's important to note that the availability of data or documents may be subject to legal or ethical considerations, such as privacy laws or data protection regulations. Additionally, some data or documents may be subject to confidentiality agreements or restrictions, which may limit who can access the information and how it can be used.
Under which criteria data/document could be used
By considering these criteria, data and documents can be used effectively and responsibly, ensuring that they are used to support valid and reliable conclusions or decisions.
From where data/document is obtainable
Shelter homes, NGOs, and overall population victims of violent women.
What processes are involved for a request to access data/document
It's important to note that in cases of violence against women, there may be additional legal protections in place to ensure the privacy and safety of the victim. Therefore, the process for accessing data/documents in these cases may be more complex and involve additional steps, such as obtaining a court order or working with an advocate or legal represent
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