A Clinical Trial of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management Among Women Facing Partner Violence

January 4, 2024 updated by: Qasir Abbas, Government College University Faisalabad
  1. Aim to investigate the effectiveness of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence
  2. To explore the effectiveness of CBT in managing depressive symptoms, stigma, worries, and emotional disturbance among women facing partner violence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this Randomized control trial, N=180 participants would be enrolled for eligibility assessment from different shelter homes in the cities of Punjab after the eligibility assessment and screening 108 participants would be allocated to experimental and waitlist treatment conditions. Participants will be allocated through matchable group characteristics. Participant's age range would be between 18 to 45 years. Each of the group will be comprised of the same number of participants. Both groups will be pre-tested and results will be recorded. A cognitive behavior therapy-based treatment plan will be formulated to address Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence. 8-10 CBT-based therapeutic sessions with 60 minutes will be conducted with the participant in a one-on-one setting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Qasir Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women living in the institutions for at least 2 weeks because of partner violence
  • Second eligibility criteria would be women with a minimum of 1 year of marital relationship will be included.
  • The age range would be 18 -48 years.
  • Women whose scores are above average on the partner violence scale would be included in the study

Exclusion Criteria:

  • Women greater than 48 years and less than 18 years will be excluded.
  • Women with medical and psychiatric comorbidities will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group

Experimental Group:

participants in the experimental group would receive 8-10 Cognitive Behaviour Therapy-based therapeutic sessions.
Behavioral: cognitive behavioral therapy
cognitive behavioral therapy would be used as intervention strategy for women facing partner violence to Clear about actual problems, re-educate about the issue of domestic problems and mental health, Logical expectations, Identify negative automatic thoughts,Thinking errors, and Improve understanding to identify which stressors trigger negative emotions. Moreover, this intervention will help to Prepare women how to deal with stress and overcome the reaction.
No Intervention: control group
Participants in the control group did not receive the said Cognative Behaviour Therapy intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eligibility Assessment:
Time Frame: 2-4 weeks
Initially, we enroll the women for eligibility assessment. Women who live in shelter home will be part of the study. After choosing, the Participants demographic form will be filled out. In demographic form information related to age, marital status, marriage type, family system, children, education and financial status. After this, eligible participants will be referred for psychological evolution.
2-4 weeks
Depression:
Time Frame: after allocation 1 week
Depression will be assessed by using Depression Anxiety Stress Scale. A score of 13, 20, 27 9, 14, 19, 18, 25, 33 corresponding to the categorization of mild moderate and sever level of depression, anxiety and stress respectively.
after allocation 1 week
Stigmatization:
Time Frame: after allocation 1 week
Intimate Partner Violence Stigma Scale will asses stigmatization. Higher score will indicate high-level stigma whereas low score indicate low level of stigma.
after allocation 1 week
Excessive Worries:
Time Frame: after allocation 1 week
Excessive worries will be assessed by using Generalized Anxiety Scale GAD-7. A score of 4,9,15 corresponding to the categorization of mild moderate and sever level of worries. Score greater than 15 will show the severe level of Anxiety.
after allocation 1 week
Emotional Management:
Time Frame: after allocation 1 week
Emotional Management will be assessed by using Emotional Regulation Scale. This scale comprised of ten items. Higher score on items 1,3,5,7,8,10 will show the higher level of Cognitive Reappraisal and higher score on items 2, 4, 6, and 9 will show the higher level of Expressive Suppression. Low score on these items will show the lower level of Cognitive Reappraisal and Expressive Suppression.
after allocation 1 week
Partner Violence:
Time Frame: after allocation 1 week
Karachi Domestic violence scale will be used to assess the intimate partner violence. The lowest score on KDVSS will be 0 and highest score on this scale will be 105.The cut-off score for indication that person facing the domestic abuse will be <29.
after allocation 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of illness
Time Frame: at the time of pre assessment (1week)
They will be assessed through interview information
at the time of pre assessment (1week)
HISTORY Of Domestic violence
Time Frame: after allocation at pre assessment (1week)
they will be assessed through history taking information
after allocation at pre assessment (1week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Government College University Faisalabad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qasir Abbas, PHD, Government College University Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GovernmentGUF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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