Cognitive Processing Therapy in Syrian Women Exposed to IPV

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 16 to 65 years
• Women only
• Healthy volunteers accepted
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Depression, Anxiety, PTSD

Being tested

Cognitive Processing Therapy (CPT)

Keywords

Cognitive Processing Therapy, Syrian women, Mental health

Medical subject headings

Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Cognitive Processing Therapy (CPT)Behavioural

  Also called 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   Measured: 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)

   Measured: 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)

   Measured: 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)

   Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Jan 2023
2. Study start5 Jan 2021
3. Primary completion1 Dec 2022
4. Study completion1 Dec 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for DepressionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.