Childbirth-Related Posttraumatic Stress DisorderCB-PTSDCPTNCT07495228
Cognitive Processing Therapy for Childbirth-Related Post-Traumatic Stress Disorder
A study testing Individual Cognitive Processing Therapy in people with Childbirth-Related Posttraumatic Stress Disorder and Childbirth-related Trauma, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childbirth-Related Posttraumatic Stress Disorder, Childbirth-related Trauma
- What is being tested?
- Individual Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe depression/suicidality requiring acute intervention
- medication changes in dose or type
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julia M Peak, M.Sc. contact
Canada1 site
Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L9C 1G2
Sheryl M Green, Ph.D., C.Psych, 905-522-1155 ext. 33672, sgreen@stjoes.ca
About this study
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:
Read more
- 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?
- Do participants find this modified 8-session CPT protocol acceptable and helpful?
- Does the treatment lead to clinically meaningful reductions in childbirth-related posttraumatic stress and related symptoms?
Participants will be asked to:
- Attend 8 weekly sessions of individual CPT for childbirth-related trauma
- Complete a self-report measure of trauma symptoms weekly (i.e., the PCL-5)
- Complete additional symptom questionnaires at baseline, post-treatment, and at one-month follow-up.
- Complete a brief qualitative interview one week after treatment to share feedback on their experience
- Being tested
- Individual Cognitive Processing Therapy
- Keywords
- Postpartum, Posttraumatic Stress Disorder, Childbirth, Childbirth-Related Posttraumatic Stress Disorder, Trauma, Cognitive Processing Therapy, mothers
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Cognitive Processing TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Individual Cognitive Processing Therapy | Experimental | Not described Receives: Behavioral: Individual Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: 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.
Measured: 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.
Measured: Administered at post-treatment (immediately after the 8-week intervention)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childbirth-Related Posttraumatic Stress DisorderStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
- Investigators
- Sheryl M Green, Ph.D., C.Psych, Principal investigator, St. Joseph's Healthcare HamiltonBenicio N Frey, MD, PhD, FRCPC, Study chair, St. Joseph's Healthcare HamiltonJulia M Peak, M.Sc, Study director, McMaster UniversityKeisha Gobin, Ph.D., C.Psych, Study chair, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495228
- Sponsor's protocol ID
- CPT for CB-PTSD
- Acronym
- CB-PTSDCPT
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processing Therapy for Childbirth-Related Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07495228
- Acronym / sponsor ID
- CB-PTSDCPT / CPT for CB-PTSD
- Keywords
- Postpartum, Posttraumatic Stress Disorder, Childbirth, Childbirth-Related Posttraumatic Stress Disorder, Trauma, Cognitive Processing Therapy, mothers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Do participants find this modified 8-session CPT protocol acceptable and helpful?
- Does the treatment lead to clinically meaningful reductions in childbirth-related posttraumatic stress and related symptoms?
Participants will be asked to:
- Attend 8 weekly sessions of individual CPT for childbirth-related trauma
- Complete a self-report measure of trauma symptoms weekly (i.e., the PCL-5)
- Complete additional symptom questionnaires at baseline, post-treatment, and at one-month follow-up.
- Complete a brief qualitative interview one week after treatment to share feedback on their experience
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individual Cognitive Processing Therapy | Experimental | Behavioral: Individual Cognitive Processing Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- severe depression/suicidality requiring acute intervention
- medication changes in dose or type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Cognitive Processing TherapyThis 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). | Behavioural | Individual Cognitive Processing Therapy |
Primary outcome
Feasibility: Recruitment Rate
Time frame: Measured through the recruitment period (up to 12 months)
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.
Feasibility: Eligibility Rate
Time frame: Measured through the recruitment period (up to 12 months)
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.
Feasibility: Session Attendance
Time frame: Measured during the treatment period, from the first to last session (up to 8 weeks)
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.
Feasibility: Homework Completion
Time frame: Measured during the treatment period, from the first to last session (up to 8 weeks)
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.
Feasibility: Treatment Completion Rate
Time frame: Measured at the end of treatment (8 weeks)
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.
Feasibility: Retention Rate
Time frame: Measured at baseline (at enrolment, 0 weeks), post-treatment (8 weeks), and one-month follow-up (12 weeks)
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.
Acceptability: measured using a Brief Qualitative Interview
Time frame: Administered one week after finishing the treatment
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.
Acceptability: measured using the Client Satisfaction Questionnaire (CSQ)
Time frame: Administered at post-treatment (immediately after the 8-week intervention)
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.
4 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- BackgroundGobin, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia M Peak, M.Sc. contact
Sheryl M Green, Ph.D., C.Psych principal investigator
St. Joseph's Healthcare Hamilton
Benicio N Frey, MD, PhD, FRCPC study chair
St. Joseph's Healthcare Hamilton
Julia M Peak, M.Sc study director
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Cognitive Processing Therapy in people with Childbirth-Related Posttraumatic Stress Disorder and Childbirth-related Trauma, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheryl M Green, Ph.D., C.Psych (905-522-1155 ext. 33672, sgreen@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment Rate (time frame: Measured through the recruitment period (up to 12 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07495228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.