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

Summary

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

Conditions

• Childbirth-Related Posttraumatic Stress Disorder
• Childbirth-related Trauma

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 includes the core components of CPT and produced clinically meaningful results. The first half of treatment focuses on identifying and modifying assimilated stuck points, while the second half of treatment focuses on challenging overaccommodated stuck points tied to five themes of beliefs that can be impacted by PTSD (i.e., safety, trust, power and control, esteem, and intimacy; McCann et al. 1988; Resick et al., 2017).

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton

  lead OTHER

Principal Investigators

• Sheryl M Green, Ph.D., C.Psych · St. Joseph's Healthcare Hamilton

• Benicio N Frey, MD, PhD, FRCPC · St. Joseph's Healthcare Hamilton

• Julia M Peak, M.Sc · McMaster University

• Keisha Gobin, Ph.D., C.Psych · St. Joseph's Healthcare Hamilton

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2028-04-01

Completion

2028-04-01

Countries

• Canada

Study Locations