Cognitive Processing Therapy for Childbirth-Related Post-Traumatic Stress Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individual Cognitive Processing Therapy.
- Who it may be relevant to
- Registry conditions: Childbirth-Related Posttraumatic Stress Disorder, Childbirth-related Trauma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Behavioral 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
Primary outcome measures
- Feasibility: Recruitment Rate [Time frame: Measured through the recruitment period (up to 12 months)]
- Feasibility: Eligibility Rate [Time frame: Measured through the recruitment period (up to 12 months)]
- Feasibility: Session Attendance [Time frame: Measured during the treatment period, from the first to last session (up to 8 weeks)]
- Feasibility: Homework Completion [Time frame: Measured during the treatment period, from the first to last session (up to 8 weeks)]
- Feasibility: Treatment Completion Rate [Time frame: Measured at the end of treatment (8 weeks)]
- Feasibility: Retention Rate [Time frame: 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 [Time frame: Administered one week after finishing the treatment]
- Acceptability: measured using the Client Satisfaction Questionnaire (CSQ) [Time frame: Administered at post-treatment (immediately after the 8-week intervention)]
Secondary outcome measures (4)
- The PTSD Checklist for DSM-5 (PCL-5) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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).]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- severe depression/suicidality requiring acute intervention
- medication changes in dose or type
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton — Hamilton
Publications
- 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
Identifiers
NCT: NCT07495228 · CPT for CB-PTSD