Cognitive Processing Therapy in Syrian Women Exposed to IPV

Not Applicable

Completed

• Conditions: Depression; Anxiety; PTSD
• Interventions: Behavioral: Cognitive Processing Therapy (CPT)

• Registration Number: NCT05674591
• Lead Sponsor: British University In Egypt

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.

Study Timeline

• Study Start: 2021-01-05
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Study First Submitted: 2022-12-14
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

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Exclusion Criteria

having:

• cognitive difficulties
• schizophrenia (or any other psychotic disorders).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Processing Therapy	Cognitive Processing Therapy (CPT)	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline on Clinician-Administered PTSD Scale at 3 months and at 12 months	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)
Change from Baseline on Beck Anxiety Inventory scores at 3 months and at 12 months	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)
Change from Baseline on Difficulties Emotion Regulation scale scores at 3 months and at 12 months	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
Women's Health and Domestic Violence against Women questionnaire	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
Change from Baseline on Beck Depression Inventory II scores at 3 months and at 12 months	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)

Trial Locations

Locations (1)

The British university in Egypt; 🇪🇬 Cairo, Egypt