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

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: Active, not recruiting
• Conditions: Cognitive Behaviour Therapy
• Intervention / Treatment: Behavioral: cognitive behavioral therapy

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: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Eligibility Assessment:	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:	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:	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:	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:	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:	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

Outcome Measure	Measure Description	Time Frame
Duration of illness	They will be assessed through interview information	at the time of pre assessment (1week)
HISTORY Of Domestic violence	they will be assessed through history taking information	after allocation at pre assessment (1week)

Collaborators and Investigators

• Sponsor: Government College University Faisalabad
• Investigators: Principal Investigator: Qasir Abbas, PHD, Government College University Faisalabad

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): April 10, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Depression Worries Stigma Emotion Cognitive behavior therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID 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