NCT06208111

Brief Summary

  1. 1.Aim to investigate the effectiveness of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence
  2. 2.To explore the effectiveness of CBT in managing depressive symptoms, stigma, worries, and emotional disturbance among women facing partner violence.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

November 29, 2023

Last Update Submit

January 4, 2024

Conditions

Keywords

Depression Worries Stigma Emotion Cognitive behavior therapy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Duration of illness

    at the time of pre assessment (1week)

  • HISTORY Of Domestic violence

    after allocation at pre assessment (1week)

Study Arms (2)

Treatment group

EXPERIMENTAL

Experimental Group: participants in the experimental group would receive 8-10 Cognitive Behaviour Therapy-based therapeutic sessions.

Behavioral: cognitive behavioral therapy

control group

NO INTERVENTION

Participants in the control group did not receive the said Cognative Behaviour Therapy intervention

Interventions

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.

Treatment group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qasir Abbas

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Qasir Abbas, PHD

    Government College University Faisalabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized control trial design will be used in this study. it would be two arm study and there would be two groups an experimental and a waitlist control group. The experimental group will receive intervention and another group will be placed on the waitlist. in this research parallel group design would be used. we will give treatment to all participants in a parallel way. The allocation ratio and framework would be equivalency i.e, the treatment group and control group be equal number of participants
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Qasir Abbas Assistant Professor Clinical Psychology

Study Record Dates

First Submitted

November 29, 2023

First Posted

January 17, 2024

Study Start

November 15, 2023

Primary Completion

February 1, 2024

Study Completion

April 10, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations