Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2025-12-17 @ 9:46 AM
Study NCT ID:
NCT06177223
Status:
None
Last Update Posted:
2023-12-20 00:00:00
First Post:
2023-12-05 00:00:00
Brief Title:
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder
Sponsor:
Government College University Faisalabad
Organization:
Government College University Faisalabad
Study Overview
Official Title:
Cognitive Behavioural Therapy for Post-Traumatic Stress Disorder (PTSD) Among Women Victims of Domestic Violence in Shelter Homes: A Randomized Control Trial
Status:
None
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Participants
Participants would be recruited from different womens 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 n30 experimental group through random assignment See Fig1 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 n30 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 n30 and the second will be the control group n30 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 260 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 womens 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 divorcedwidowed 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
Participants would be recruited from different womens 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 n30 experimental group through random assignment See Fig1 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 n30 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 n30 and the second will be the control group n30 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 260 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 womens 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 divorcedwidowed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None