Cognitive Processing Therapy for Childbirth-Related Post-Traumatic Stress Disorder

Обзор

The goal of this clinical trial is to determine whether participation in an individual 8-session cognitive processing therapy (CPT) is feasible, acceptable, and leads to clinically meaningful trauma symptom reduction in individuals experiencing childbirth-related trauma. The main questions it aims to answer are: 1. Is it feasible for women and birthing people to attend and complete an 8-session course of CPT delivered virtually within a specialized women's mental health clinic? 2. Do participants find this modified 8-session CPT protocol acceptable and helpful? 3. Does the treatment lead to clinically meaningful reductions in childbirth-related posttraumatic stress and related symptoms? Participants will be asked to: 1. Attend 8 weekly sessions of individual CPT for childbirth-related trauma 2. Complete a self-report measure of trauma symptoms weekly (i.e., the PCL-5) 3. Complete additional symptom questionnaires at baseline, post-treatment, and at one-month follow-up. 4. Complete a brief qualitative interview one week after treatment to share feedback on their experience

Вмешательства

• Поведенческое Individual Cognitive Processing Therapy
  This is the first clinical trial using Cognitive Processing Therapy (CPT) to treat Childbirth-Related Posttraumatic Stress Disorder (CB-PTSD). CPT is considered a frontline treatment for treating PTSD, but has only been applied to treat CB-PTSD in case study format. While CPT is traditionally a 12-session protocol, to make attendance more feasible for a postpartum population, a shortened 8-session protocol will be used (adapted by Gobin, K. C., Boyd, J. E., and Green, S. M). This protocol includ

Первичные конечные точки

• Feasibility: Recruitment Rate [Срок оценки: Measured through the recruitment period (up to 12 months)]
• Feasibility: Eligibility Rate [Срок оценки: Measured through the recruitment period (up to 12 months)]
• Feasibility: Session Attendance [Срок оценки: Measured during the treatment period, from the first to last session (up to 8 weeks)]
• Feasibility: Homework Completion [Срок оценки: Measured during the treatment period, from the first to last session (up to 8 weeks)]
• Feasibility: Treatment Completion Rate [Срок оценки: Measured at the end of treatment (8 weeks)]
• Feasibility: Retention Rate [Срок оценки: Measured at baseline (at enrolment, 0 weeks), post-treatment (8 weeks), and one-month follow-up (12 weeks)]
• Acceptability: measured using a Brief Qualitative Interview [Срок оценки: Administered one week after finishing the treatment]
• Acceptability: measured using the Client Satisfaction Questionnaire (CSQ) [Срок оценки: Administered at post-treatment (immediately after the 8-week intervention)]

Вторичные конечные точки (4)

• The PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Administered at baseline (at enrolment), weekly throughout treatment, post-treatment (immediately after the 8 week intervention), and at the 1 month follow-up (one month after intervention completion).]
• City Birth Trauma Scale (CBTS) [Срок оценки: Administered at baseline (at enrolment), post-treatment (immediately after the 8 week intervention), and at the 1 month follow-up (one month after intervention completion).]
• Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: Administered at baseline (at enrolment), post-treatment (immediately after the 8 week intervention), and at the 1 month follow-up (one month after intervention completion).]
• Generalized Anxiety Disorder 7-Item Scale (GAD-7) [Срок оценки: Administered at baseline (at enrolment), post-treatment (immediately after the 8 week intervention), and at the 1 month follow-up (one month after intervention completion).]

Критерии участия

Критерии включения

• women/birthing people aged 18 years and older who are fluent in English (able to speak/understand and read English), and who are at least one month postpartum
• either indicate clinical levels of PTSD related to a traumatic birth (i.e., 31 or higher on the PCL-5) or endorse significant distress or impairment as a result of their traumatic childbirth experience
• not receiving concurrent psychological treatment
• not taking psychoactive medication or if taking medications, are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; McQueen et al., 2016) and remain stable throughout the study

Критерии исключения

• severe depression/suicidality requiring acute intervention
• medication changes in dose or type

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton — Hamilton

Публикации

• Gobin, K. C., Boyd, J. E., & Green, S. M. (2023). Cognitive Processing Therapy for Childbirth-Related Posttraumatic Stress Disorder: A Case Report. Cognitive and Behavioral Practice, 30(1), 133-145. https://doi.org/10.1016/j.cbpra.2021.12.004

Идентификаторы

NCT: NCT07495228 · CPT for CB-PTSD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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