Cognitive Behavioral TherapyNCT06177223
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder
A study testing Cognitive Behavioral therapy in people with Cognitive Behavioral Therapy, run by Government College University Faisalabad at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Cognitive Behavioral Therapy
- What is being tested?
- Cognitive Behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2023to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Divorced/widowed, Single
- Women with medical comorbidity
- Women with physical problems
- Minimum to 20 years of age
- Maximum to 50 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioural Therapy for Post-Traumatic Stress Disorder (PTSD) Among Women Victims of Domestic Violence in Shelter Homes: A Randomized Control Trial
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
- To examine the efficacy of CBT to overcome the severity level of PTSD and associated psychiatric problems.
- To change negative thought patterns and dysfunctional cognition into functional thoughts and beliefs.
- To build up social support, enhance the quality of life and refine mental health among patients with PTSD.
- To check outs the association of PTSD with depression, intimate partner violence stigma, marital adjustment, and abuse.
- 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
Read the detailed 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.
- Conditions
- Cognitive Behavioral Therapy
- Being tested
- Cognitive Behavioral therapy
- Keywords
- Cognitive Behavioral Therapy, Domestic Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral therapyBehavioural
CBT-based treatment plan would be designed to address PTSD and associated problems.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Cognitive Behavioral Therapy based sessions would be conducted with women victims of domestic violence in shelter homes Receives: Behavioral: Cognitive Behavioral therapy |
| Waitlist Control Group | No intervention | no intervention would be given to the participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after allocation (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start10 Nov 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasir Abbas, Government College University Faisalabad
- Investigators
- Qasir Abbas, PHD, Principal investigator, Government College University, Faislabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177223
- Sponsor's protocol ID
- nazishghafoor14@gmail.com
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Post-Traumatic Stress Disorder (PTSD) Among Women Victims of Domestic Violence in Shelter Homes: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06177223
- Acronym / sponsor ID
- nazishghafoor14@gmail.com
- Conditions
- Cognitive Behavioral Therapy
- Keywords
- Cognitive Behavioral Therapy, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To examine the efficacy of CBT to overcome the severity level of PTSD and associated psychiatric problems.
- To change negative thought patterns and dysfunctional cognition into functional thoughts and beliefs.
- To build up social support, enhance the quality of life and refine mental health among patients with PTSD.
- To check outs the association of PTSD with depression, intimate partner violence stigma, marital adjustment, and abuse.
- 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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Cognitive Behavioral therapyCognitive Behavioral Therapy based sessions would be conducted with women victims of domestic violence in shelter homes |
| Waitlist Control Group | No intervention | –no intervention would be given to the participants |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Divorced/widowed, Single
- Women with medical comorbidity
- Women with physical problems
- Minimum to 20 years of age
- Maximum to 50 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral therapyCBT-based treatment plan would be designed to address PTSD and associated problems. | Behavioural | Treatment Group |
Primary outcome
Post Traumatic Stress Disorder
Time frame: 3-5 weeks
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.
Domestic Violence
Time frame: after allocation (1 week)
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.
Depression
Time frame: after allocation (1 week)
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.
Marital Adjustment
Time frame: after allocation (1 week)
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.
Intimate partner Violence Stigma
Time frame: after allocation (1 week)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Cognitive Behavioral Therapy
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
Not yet recruiting
Negotiation Training for Family Caregivers of People With Alzheimer's Disease
Alzheimer's Disease (AD), Dementia
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Not yet recruiting
AI-Based CBT Chatbot for Adolescent Social Anxiety
AI-CBT Intervention Group, Waitlist Control Group
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qasir Abbas, PHD principal investigator
Government College University, Faislabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral therapy in people with Cognitive Behavioral Therapy, run by Government College University Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Stress Disorder (time frame: 3-5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.