Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder

Cognitive Behavioral Therapy Clinical Trial

Official title:

Cognitive Behavioural Therapy for Post-Traumatic Stress Disorder (PTSD) Among Women Victims of Domestic Violence in Shelter Homes: A Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06177223
• Other study ID #: nazishghafoor14@gmail.com
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: April 10, 2024

Study information

• Verified date: December 2023
• Source: Government College University Faisalabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. To examine the efficacy of CBT to overcome the severity level of PTSD and associated psychiatric problems.

2. To change negative thought patterns and dysfunctional cognition into functional thoughts and beliefs.

3. To build up social support, enhance the quality of life and refine mental health among patients with PTSD.

4. To check outs the association of PTSD with depression, intimate partner violence stigma, marital adjustment, and abuse.

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

Description:

Participants

Participants would be recruited from different women's shelters Homes. An Initial sample would be included total 200 participants. The final sample would be comprise 60 participants with age ranges will be 20 to 60 years. For collecting the sample, the Simple Random Sampling technique would be used. In this research, women with PTSD would be divided into two equal groups that would be n= 30 as the control group and n=30 experimental group through random assignment (See Fig.1: CONSORT Flowchart Diagram). One group diagnosed with PTSD would be providing 10 to 12 sessions of CBT. One other group diagnosed with PTSD depending on n=30 would not be provided CBT sessions. This research will be divided into 3 parts. In first initial procedure will be performed in which participants will be selected by simple random sampling. All women who live in shelters will be part of the study. After choosing the participant demographic form will be filled out. In demographic form information related to participants will be taken. This information will consist of age, gender, marital status, sibling, children, education, and financial status. In the second step, a standardized tool will be used to measure the symptoms of post-traumatic stress disorder. The pre-test will be taken from participants following: 1) LWMAT will measure the marital adjustment level of participants, 2) IPVSS will be for assess partner violence stigma symptoms, Domestic Violence Scale to measure domestic violence, PHQ-9 for measuring depression level, and PCL-5 for PTSD related symptoms according to DSM 5TR. A participant who has a high rate of PCL-5 and shows PTSD symptoms will be chosen for the experiment. Further, participants will be divided into two groups. One group is the experimental group n=30 and the second will be the control group n=30. In the next step, CBT techniques will be provided to the experimental group by the trained therapist. Following CBT techniques will be provided psycho-education, behavioral activation, problem-solving, cognitive conceptualization, stigma reduction, and relapse prevention. Furthermore, the control group will not be provided with CBT techniques. At the end of this procedure, patients will be re-assessed through the same measures as the post-test. All these assessments will be interpreted according to a given method by the author. A paired t-test will be used to find a correlation between the pre-test and post-test. Statistics will be applied using SPSS 26.0. Session frequency will be once a week and last approximately 40-45 minutes. The tentative duration would be 3 months. The session would be conducted one-on-one sitting in the women's shelter setting.

Eligibility Criteria

Participants that will be participated in this research would be Women who experienced domestic violence and who are meeting the DSM-V diagnostic criteria of PTSD with at least one year of history of marital issues. Only those women who live in the Shelters will be part of the research. Women with separation, divorced/widowed, single, and with medical comorbidity will be excluded from the study. Women who have physical problems will be excluded. Those women who intended to research will be part of the research. Women who have no PTSD symptoms will be excluded. The age ranges between 20 to 50 years will be included. Greater than 50 years and less than 20 years women will be excluded.

Interventions

CBT-based treatment plan would be designed to address PTSD and associated problems. 10-12 sessions will be structured having particular agendas. In each session, the therapist would try to achieve the target goal using particular techniques, interventions, and modalities to address the target goals.

Expected outcomes

CBT will treat cognitive distortions, negative feelings and emotions, and irrational beliefs, which are associated with trauma as well as improve social interaction, trauma reduction, marital satisfaction, and daily life functioning.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 10, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Divorced/widowed, Single

• Women with medical comorbidity

• Women with physical problems

• Minimum to 20 years of age

• Maximum to 50 years

Related Conditions & MeSH terms

• Cognitive Behavioral Therapy
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Behavioral therapy
CBT-based treatment plan would be designed to address PTSD and associated problems.

Locations

Country	Name	City	State
Pakistan	Dr. Qasir Abbas	Faisalabad	Province

Sponsors (1)

Lead Sponsor	Collaborator
Government College University Faisalabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)