Cognitive Processing Therapy for Childbirth-Related Post-Traumatic Stress Disorder (CB-PTSDCPT)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Childbirth-Related Posttraumatic Stress Disorder; Childbirth-related Trauma
• Intervention / Treatment: Behavioral: Individual Cognitive Processing Therapy

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheryl M Green, Ph.D., C.Psych; Phone Number: 33672 905-522-1155; Email: sgreen@stjosham.on.ca
• Study Contact Backup: Name: Julia M Peak, M.Sc.; Email: jpeak@stjoes.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L9C 1G2
      • Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton
      • Contact: Sheryl M Green, Ph.D., C.Psych; Phone Number: 33672 905-522-1155; Email: sgreen@stjoes.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Individual Cognitive Processing Therapy

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Recruitment Rate	Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Recruitment rates, reflecting the portion of individuals that express interest and enroll in the study, will provide information about our recruitment process and whether this is sufficient for conducting the study. This will be calculated as a percentage of the proportion of individuals who express interest in the study and subsequently enroll.	Measured through the recruitment period (up to 12 months)
Feasibility: Eligibility Rate	Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention, including the eligibility rate. Eligibility rate will be calculated as the proportion in percentage of screened individuals who meet inclusion and exclusion criteria.	Measured through the recruitment period (up to 12 months)
Feasibility: Session Attendance	Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Weekly session attendance will be used to assess engagement with treatment components. Session attendance will be calculated as the proportion of treatment sessions attended out of the total number of sessions.	Measured during the treatment period, from the first to last session (up to 8 weeks)
Feasibility: Homework Completion	Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Homework completion will be used to assess engagement with treatment components. Homework completion will be assessed as the proportion of assigned homework tasks completed during the intervention period.	Measured during the treatment period, from the first to last session (up to 8 weeks)
Feasibility: Treatment Completion Rate	Treatment completion rates will indicate whether the treatment is feasible for a predominantly postpartum population. Treatment completion will be defined as the proportion of participants who complete 6 or more out of 8 sessions.	Measured at the end of treatment (8 weeks)
Feasibility: Retention Rate	Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Retention rates (i.e., continued participation in study assessments - baseline, post-treatment, one-month follow-up), will provide information about the feasibility of collecting outcome data over time.	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	At one-week post-treatment, participants will attend a brief qualitative interview to review treatment progress and provide feedback on their care, including what aspects of the treatment were helpful and what could be improved, as well as feedback on the length of treatment and its delivery. This does not include a specific number or scale, rather, qualitative feedback on the treatment and their care will be reported on.	Administered one week after finishing the treatment
Acceptability: measured using the Client Satisfaction Questionnaire (CSQ)	The CSQ is an 8-item self-report scale designed to measure satisfaction with health services (Larsen et al., 1979). Items are scored on a 4-point scale from 1 to 4, with higher scores indicating higher levels of satisfaction with services. Scores can range from 8 to 32.	Administered at post-treatment (immediately after the 8-week intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The PTSD Checklist for DSM-5 (PCL-5)	The PTSD checklist, or PCL-5, screens individuals for PTSD by assessing the symptoms of PTSD outlined by the DSM-5. It is a 20-item self-report measure that requires users to rate each symptom statement on a scale from 0 (not at all) to 4 (extremely) to indicate how much they have been impacted by that symptom in the past month. For example, "In the past month, how much have you been bothered by repeated, disturbing dreams of the stressful experience?" During treatment, the PCL-5 will be completed on a weekly basis before each session, and the investigators will use the version that is the exact same but refers to symptoms in the past week rather than the past month. Final scores can range from 0-80 by summing item responses together, with higher scores indicating greater trauma symptoms.	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)	The City Birth Trauma Scale is a self-report questionnaire designed to assess birth-related trauma symptoms and PTSD. It has 29 items that measure PTSD according to the diagnostic criteria of the DSM-5. The first two questions reflect whether the individual experienced a Criterion A traumatic event related to childbirth, asking whether there was belief of serious injury or death to self or baby during the labour, birth, or immediately afterwards. The remaining questions ask about DSM-5 PTSD-related symptoms during or immediately after an individual's labour and birth. It requires users to rate how frequently they experience each symptom statement on a scale of 0 (not at all), once, 2-4 times, or 5 or more times. Scores can range from 0 to 60, with higher scores indicating greater frequency of symptoms.	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)	The EPDS is a 10-item self-report measure that assesses symptoms of depression during the perinatal period (Murray & Cox, 1990). Items are scored on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater depressive symptomatology. Scores can range from 0 to 30.The EPDS has demonstrated good sensitivity and specificity for a diagnosis of Major Depressive Disorder (MDD). Cut-off scores of 15 and 13 or higher have been suggested for detecting a probable diagnosis of MDD during pregnancy and the postpartum period, respectively (Matthey et al., 2006).	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)	The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over a previous two-week period (Spitzer et al., 2006). Items are measured on a 4-point scale ranging from 0 ('not at all') to 3 ('nearly every day'). Scores can range from 0 to 21, with higher scores indicating greater severity of symptoms. A cut-off score of 10 or higher with sensitivity of 89% and specificity of 82% has been suggested for detecting a probable diagnosis of Generalized Anxiety Disorder (Spitzer et al., 2006). The GAD-7 has also been validated for use in perinatal samples (Simpson et al., 2014).	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).

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Sheryl M Green, Ph.D., C.Psych, St. Joseph's Healthcare Hamilton; Study Chair: Benicio N Frey, MD, PhD, FRCPC, St. Joseph's Healthcare Hamilton; Study Director: Julia M Peak, M.Sc, McMaster University; Study Chair: Keisha Gobin, Ph.D., C.Psych, St. Joseph's Healthcare Hamilton

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum; Posttraumatic Stress Disorder; mothers; Trauma; Childbirth; Cognitive Processing Therapy; Childbirth-Related Posttraumatic Stress Disorder
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CPT for CB-PTSD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No