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Completed

NCT Number: NCT05674591

Cognitive Processing Therapy in Syrian Women Exposed to IPV

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

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Key information

Age range

16 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The British university in Egypt

Cairo, 11837, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive Processing Therapy (CPT)

Behavioral

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: CPT

Primary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

Cognitive Processing Therapy for the Treatment of Depression, Anxiety, PTSD, and Difficulties in Emotion Regulation in Syrian Females Exposed to Intimate Partner Violence

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2023
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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