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Cognitive Processing Therapy in Syrian Women Exposed to IPV

Primary Purpose

Depression, Anxiety, PTSD

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cognitive Processing Therapy (CPT)
Sponsored by
British University In Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Cognitive Processing Therapy, Syrian women, Mental health

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: being a Syrian female who currently exposes to intimate partner violence, lives in Egypt has a good knowledge of English language because all assessments and therapy materials are in English. Exclusion Criteria: having: cognitive difficulties schizophrenia (or any other psychotic disorders).

Sites / Locations

  • The British university in Egypt

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Processing Therapy

Arm Description

Cognitive Processing Therapy (CPT) is a manual-guided therapy that incorporates cognitive processing techniques to relieve PTSD symptoms (Resick et al., 2016). Each group session will be 90 to 120 minutes long and will be occur once each week for 12 weeks.

Outcomes

Primary Outcome Measures

Women's Health and Domestic Violence against Women questionnaire
Version 11 of the WHO Multi-Country Study on Women's Health and Domestic Violence against Women questionnaire (WHO, 2005). This instrument comprises of an informed consent form, a household questionnaire, and a 1-item questionnaire regarding the circumstances of women. The WHO Multi-country Study on Women's Health and Domestic Violence assesses whether women have been subjected to any kind of intimate partner violence throughout their lives. The four components of intimate partner violence are physical, sexual, emotional, and controlling violence. Indicators were dichotomous, with 1 indicating whether or not the individual was a victim of IPV (1 = "Yes", 0 = "No"). Women were asked a number of questions on whether they had ever encountered a variety of behaviours belonging to one of the four groups. For each act of violence, participants will be required to identify whether it had occurred in their lives and how frequently it had occurred
Change from Baseline on Clinician-Administered PTSD Scale at 3 months and at 12 months
Currently, the CAPS-5 (Weathers et al., 2015) is the global standard for PTSD evaluation and is used to evaluate PTSD symptoms. This 30-item structured interview was created by the National Centre for PTSD of the US Department of Veterans Affairs. Generally, the interview may be conducted in 45 to 60 minutes. Each CAPS-5 question addresses both the frequency and severity of each PTSD symptom. These questions have been categorized. Each criteria comprises many questions, and at the end, the points for each criterion are totaled together. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. The cutoff score for CAPS-5 is 45. Higher scores on CAPS mean a worse outcome. Improvement was defined as a 5 point reduction in the overall CAPS-5 scores. Remission was defined as loss of diagnosis and no longer having any PTSD symptoms according to minimum severity scores on CAPS-5 (< 12)
Change from Baseline on Beck Depression Inventory II scores at 3 months and at 12 months
BDI-II measured depression symptoms. BDI-II is a 21-item self-report assessment measuring depressive attitudes and symptoms (Beck et al., 1996). BDI-II takes 10 minutes. Minimal range=0-13, mild depression=14-19, moderate depression=20-28, and severe depression=29-63. BDI-II is reliable and valid (Beck et al., 1996)
Change from Baseline on Beck Anxiety Inventory scores at 3 months and at 12 months
BAI measures somatic anxiety symptoms as anxiousness, dizziness, and inability to relax (Beck et al., 1988). It takes 10 to 15 minutes to finish 21 items. Four-point Likert scale answers vary from zero to three (severely). The total score for all 21 symptoms ranges from 0 to 63 points. A score of 0-7 indicates "little" anxiety, 8-15 "mild," 16-25 "moderate," and 26-63 "severe" (Beck & Steer 1990)
Change from Baseline on Difficulties Emotion Regulation scale scores at 3 months and at 12 months
The DERS was created by Gratz and Roemer (2004) and consists of a 36-item self-report questionnaire that evaluates the difficulty in regulating emotions. Bjureberg et al. (2016) created a 16-item abbreviated version of the DERS later on. There are three items about nonacceptance, three items regarding difficulties participating in goal-directed actions, three things regarding impulsivity, five items regarding trouble utilizing emotion regulation strategies, and two items regarding emotional clarity Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. Higher scores on DERS mean a worse outcome

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
January 5, 2023
Sponsor
British University In Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05674591
Brief Title
Cognitive Processing Therapy in Syrian Women Exposed to IPV
Official Title
Cognitive Processing Therapy for the Treatment of Depression, Anxiety, PTSD, and Difficulties in Emotion Regulation in Syrian Females Exposed to Intimate Partner Violence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British University In Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to explore the efficacy of cognitive processing therapy (CPT) in treating depression, anxiety, PTSD, and difficulties with emotion regulation in Syrian females who have suffered intimate partner violence (IPV). Clinicians will conduct interviews with women and request that they complete the CAPS, Beck Depression Inventory II, Beck Anxiety Inventory, and DERS during pretreatment, posttreatment, and at the 12-month follow-up
Detailed Description
This study aims to explore the efficacy of cognitive processing therapy (CPT) in treating depression, anxiety, PTSD, and difficulties with emotion regulation in Syrian females who have suffered intimate partner violence (IPV). Clinicians will conduct interviews with women and request that they complete the CAPS, Beck Depression Inventory II, Beck Anxiety Inventory, and DERS during pretreatment, posttreatment, and at the 12-month follow-up. Cognitive processing therapy (CPT) may have a substantial therapeutic benefit in the treatment of depression, anxiety, PTSD, and difficulties in emotion regulation among Syrian females who have suffered intimate partner violence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, PTSD
Keywords
Cognitive Processing Therapy, Syrian women, Mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The current study is a clinical trial, including the repeated assessments of a single sample of Syrian women. Pre-treatment, posttreatment and 12-month posttreatment assessments were conducted on participants. PTSD severity, depression, anxiety and difficulties in emotion regulation will be assessed as outcomes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy
Arm Type
Experimental
Arm Description
Cognitive Processing Therapy (CPT) is a manual-guided therapy that incorporates cognitive processing techniques to relieve PTSD symptoms (Resick et al., 2016). Each group session will be 90 to 120 minutes long and will be occur once each week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT)
Other Intervention Name(s)
CPT
Intervention Description
The CPT therapist will teach the patient about PTSD, depression, and anxiety, and outline the treatment regimen and rationale for its effectiveness. In the initial sessions, women will be asked to express their impact statements on the intimate partner violence to which they had been subjected. Women will be taught how to differentiate between events, thoughts, and emotions, as well as their interrelationships. Thoughts of self-blame and other misconceptions of the situation will be addressed using Socratic questioning. Women will be instructed on how to detect and counteract negative thoughts, as well as how to communicate more effectively. Women will be encouraged to evaluate negative thinking relating to five themes: safety, trust, power/control, self-esteem, and intimacy. During the final sessions, their impact statements on the violence to which they had been subjected will be altered to include emotional and cognitive insights obtained during the CPT.
Primary Outcome Measure Information:
Title
Women's Health and Domestic Violence against Women questionnaire
Description
Version 11 of the WHO Multi-Country Study on Women's Health and Domestic Violence against Women questionnaire (WHO, 2005). This instrument comprises of an informed consent form, a household questionnaire, and a 1-item questionnaire regarding the circumstances of women. The WHO Multi-country Study on Women's Health and Domestic Violence assesses whether women have been subjected to any kind of intimate partner violence throughout their lives. The four components of intimate partner violence are physical, sexual, emotional, and controlling violence. Indicators were dichotomous, with 1 indicating whether or not the individual was a victim of IPV (1 = "Yes", 0 = "No"). Women were asked a number of questions on whether they had ever encountered a variety of behaviours belonging to one of the four groups. For each act of violence, participants will be required to identify whether it had occurred in their lives and how frequently it had occurred
Time Frame
At first interview, pretreatment
Title
Change from Baseline on Clinician-Administered PTSD Scale at 3 months and at 12 months
Description
Currently, the CAPS-5 (Weathers et al., 2015) is the global standard for PTSD evaluation and is used to evaluate PTSD symptoms. This 30-item structured interview was created by the National Centre for PTSD of the US Department of Veterans Affairs. Generally, the interview may be conducted in 45 to 60 minutes. Each CAPS-5 question addresses both the frequency and severity of each PTSD symptom. These questions have been categorized. Each criteria comprises many questions, and at the end, the points for each criterion are totaled together. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. The cutoff score for CAPS-5 is 45. Higher scores on CAPS mean a worse outcome. Improvement was defined as a 5 point reduction in the overall CAPS-5 scores. Remission was defined as loss of diagnosis and no longer having any PTSD symptoms according to minimum severity scores on CAPS-5 (< 12)
Time Frame
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
Title
Change from Baseline on Beck Depression Inventory II scores at 3 months and at 12 months
Description
BDI-II measured depression symptoms. BDI-II is a 21-item self-report assessment measuring depressive attitudes and symptoms (Beck et al., 1996). BDI-II takes 10 minutes. Minimal range=0-13, mild depression=14-19, moderate depression=20-28, and severe depression=29-63. BDI-II is reliable and valid (Beck et al., 1996)
Time Frame
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
Title
Change from Baseline on Beck Anxiety Inventory scores at 3 months and at 12 months
Description
BAI measures somatic anxiety symptoms as anxiousness, dizziness, and inability to relax (Beck et al., 1988). It takes 10 to 15 minutes to finish 21 items. Four-point Likert scale answers vary from zero to three (severely). The total score for all 21 symptoms ranges from 0 to 63 points. A score of 0-7 indicates "little" anxiety, 8-15 "mild," 16-25 "moderate," and 26-63 "severe" (Beck & Steer 1990)
Time Frame
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
Title
Change from Baseline on Difficulties Emotion Regulation scale scores at 3 months and at 12 months
Description
The DERS was created by Gratz and Roemer (2004) and consists of a 36-item self-report questionnaire that evaluates the difficulty in regulating emotions. Bjureberg et al. (2016) created a 16-item abbreviated version of the DERS later on. There are three items about nonacceptance, three items regarding difficulties participating in goal-directed actions, three things regarding impulsivity, five items regarding trouble utilizing emotion regulation strategies, and two items regarding emotional clarity Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. Higher scores on DERS mean a worse outcome
Time Frame
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females only
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: being a Syrian female who currently exposes to intimate partner violence, lives in Egypt has a good knowledge of English language because all assessments and therapy materials are in English. Exclusion Criteria: having: cognitive difficulties schizophrenia (or any other psychotic disorders).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amani Elbarazi, PhD
Organizational Affiliation
The British University in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
The British university in Egypt
City
Cairo
ZIP/Postal Code
11837
Country
Egypt

12. IPD Sharing Statement

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Cognitive Processing Therapy in Syrian Women Exposed to IPV

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