NCT06177223

Brief Summary

The current study is designed to measure the role of cognitive behavior therapy with PTSD patients. There are following objectives of this current study, such as

  1. 1.To examine the efficacy of CBT to overcome the severity level of PTSD and associated psychiatric problems.
  2. 2.To change negative thought patterns and dysfunctional cognition into functional thoughts and beliefs.
  3. 3.To build up social support, enhance the quality of life and refine mental health among patients with PTSD.
  4. 4.To check outs the association of PTSD with depression, intimate partner violence stigma, marital adjustment, and abuse.
  5. 5.This study would examine the efficacy of CBT to treat the severity of PTSD and associated problems (i.e. depressive symptoms, adjustment problems \& discrimination) among women victims of domestic violence in shelter homes

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
200

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 10, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 5, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

Cognitive Behavioral Therapy, Domestic Violence

Outcome Measures

Primary Outcomes (5)

  • Post Traumatic Stress Disorder

    The Post Traumatic Stress Disorder assessed by PTSD Checklist for Diagnostic and Statistical Manual of Mental Health Disorder-Fifth Edition (PCL-5) is a 20-item self-report measure. A total symptom severity score (range \_0-80) can be obtained by summing the scores for each of the 20 items. Cutoff score between 31-33 indicative diagnosis of PTSD.

    3-5 weeks

  • Domestic Violence

    Karachi domestic violence screening scale used to measure intimate partner violence. It contains 35 items having 5 subscales i.e., physical abuse, psychological abuse, sexual abuse, victim characteristic, abuser characteristic. Total score ranges between 0 to 105 and cut off score is 30. Score ranges categorized as no abuse= 0-19, mild= 20-35, moderate= 36-59, severe= 60-105.

    after allocation (1 week)

  • Depression

    Depression will be assessed by using Patient Health Questionnaire-9. The total scores of 5, 10, 15, and 20 are taken as mild, moderate, moderately severe, and severe respectively.

    after allocation (1 week)

  • Marital Adjustment

    Locke Wallace Marital Adjustment Test used to measure adjustment level in married couples as high or low and agreement or disagreement on the cause of conflicted issues as well. It's score ranges from 2 to 158. The cut off score is 100, which indicate maladjustment in marital life. High score reflects high rate of satisfaction.

    after allocation (1 week)

  • Intimate partner Violence Stigma

    The intimate partner violence stigma scale used for measuring stigma associated to intimate partner violence. This scale has four subscales that measure stigma including anticipated stigma, perpetrator stigma, internalized stigma, and isolation. High score indicate high stiga.

    after allocation (1 week)

Study Arms (2)

Treatment Group

EXPERIMENTAL

Cognitive Behavioral Therapy based sessions would be conducted with women victims of domestic violence in shelter homes

Behavioral: Cognitive Behavioral therapy

Waitlist Control Group

NO INTERVENTION

no intervention would be given to the participants

Interventions

CBT-based treatment plan would be designed to address PTSD and associated problems.

Treatment Group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly married women and those who are living in shelter home would be part of the study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who experienced domestic violence
  • Diagnosed women of PTSD from DSM-V
  • Women with at least one year of history of marital issues
  • Women living in the Shelters
  • Intended to Research

You may not qualify if:

  • Divorced/widowed, Single
  • Women with medical comorbidity
  • Women with physical problems
  • Minimum to 20 years of age
  • Maximum to 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Qasir Abbas

Faisalabad, 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, Faislabad.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial design would be used in this study. it would be two arm study and there would be two groups an experimental and wait-list control group. Experimental group will receive intervention and another group would be placed in waitlist. In this research , parallel group design would be used. We will give treatment to all participants in a parallel way. Allocation ratio and framework would be equivalence i.e., treatment group and control group would 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

December 5, 2023

First Posted

December 20, 2023

Study Start

November 10, 2023

Primary Completion

January 30, 2024

Study Completion

April 10, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations