- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05674591
Cognitive Processing Therapy in Syrian Women Exposed to IPV
Cognitive Processing Therapy for the Treatment of Depression, Anxiety, PTSD, and Difficulties in Emotion Regulation in Syrian Females Exposed to Intimate Partner Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11837
- The British university in Egypt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Processing Therapy
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Women's Health and Domestic Violence against Women questionnaire
Time Frame: At first interview, pretreatment
|
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
|
At first interview, pretreatment
|
Change from Baseline on Clinician-Administered PTSD Scale at 3 months and at 12 months
Time Frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
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)
|
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
Change from Baseline on Beck Depression Inventory II scores at 3 months and at 12 months
Time Frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
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)
|
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
Change from Baseline on Beck Anxiety Inventory scores at 3 months and at 12 months
Time Frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
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) |
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
Change from Baseline on Difficulties Emotion Regulation scale scores at 3 months and at 12 months
Time Frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
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
|
baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amani Elbarazi, PhD, The British university in Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Cognitive Processing Therapy (CPT)
-
VA Office of Research and DevelopmentNot yet recruiting
-
The University of Texas Health Science Center at...CompletedStress Disorders, Post-Traumatic | TinnitusUnited States
-
University of Wisconsin, MadisonUS Department of Veterans AffairsCompletedPost-Traumatic Stress DisorderUnited States
-
VA Pacific Islands Health Care SystemCompletedPosttraumatic Stress DisorderUnited States
-
Hampton VA Medical CenterTerminatedPost-traumatic Stress Disorder | Stress Disorder, Post-TraumaticUnited States
-
University of Wisconsin, MadisonCompleted
-
University of North Texas, Denton, TXDuke University; The University of Texas Health Science Center at San Antonio; Boston VA Research Institute, Inc... and other collaboratorsUnknownInsomnia | Trauma | NightmaresUnited States
-
British University In EgyptCompletedPosttraumatic Stress Disorder (PTSD)Egypt
-
St. Joseph's Healthcare HamiltonCompletedBorderline Personality Disorder | Posttraumatic Stress DisorderCanada
-
VA Pacific Islands Health Care SystemUnited States Department of Defense; AnthroTronix, Inc.CompletedStress Disorders, Post-TraumaticUnited States