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CompletedNCT05674591Updated Jan 6, 2023

Cognitive Processing Therapy in Syrian Women Exposed to IPV

An interventional study of Cognitive Processing Therapy (CPT) in Depression, Anxiety and PTSD, sponsored by British University In Egypt. Completed at 1 site in Egypt. Open to female participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-06.

Sponsored by British University In Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2021, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
16 Years to 65 Years
Sex
Female
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Study 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

Read the 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.

02

Conditions studied

  • Depression
  • Anxiety
  • PTSD

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Keywords

  • Cognitive Processing Therapy
  • Syrian women
  • Mental health
03

In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 30 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

British University In Egypt is the lead sponsor of 67 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Behavioral: Cognitive Processing Therapy (CPT)

Interventions

  • BehavioralCognitive Processing Therapy (CPT)

    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.

    Also known as: CPT

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What researchers measure

Primary outcomes

  1. 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

    Time frame: At first interview, pretreatment

  2. 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)

    Time frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention

  3. 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)

    Time frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention

  4. 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)

    Time frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention

  5. 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

    Time frame: baseline (pre-intervention), posttreatment (immediately after the intervention, an average of 3 months), 12-months after the intervention

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Study locations

1 site
  • The British university in Egypt
    Cairo, 11837, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05674591
Lead sponsor
British University In Egypt
Responsible party
Sponsor
First posted
Jan 6, 2023
Start date
Jan 5, 2021
Primary completion
Dec 1, 2022
Completion
Dec 1, 2022
Last update
Jan 6, 2023

Study contacts

Amani Elbarazi, PhD
principal investigator · The British University in Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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