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Cognitive Processing Therapy for Birth Trauma

(CB-PTSDCPT Trial)

JM
SM
Overseen BySheryl M Green, Ph.D., C.Psych
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: St. Joseph's Healthcare Hamilton
Must not be taking: Psychoactive medications
Disqualifiers: Severe depression, Suicidality, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

JM

Julia M Peak, M.Sc

Principal Investigator

McMaster University

SM

Sheryl M Green, Ph.D., C.Psych

Principal Investigator

St. Joseph's Healthcare Hamilton

BN

Benicio N Frey, MD, PhD, FRCPC

Principal Investigator

St. Joseph's Healthcare Hamilton

KG

Keisha Gobin, Ph.D., C.Psych

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

Inclusion Criteria

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
I am not currently getting psychological treatment.
I am a woman or birthing person over 18, fluent in English, and at least one month postpartum.
See 1 more

Exclusion Criteria

Severe depression/suicidality requiring acute intervention
I have recently changed the dose or type of my medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 8 weekly sessions of individual cognitive processing therapy (CPT) for childbirth-related trauma

8 weeks
8 visits (virtual)

Follow-up

Participants complete additional symptom questionnaires and a brief qualitative interview to provide feedback on their experience

4 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Individual Cognitive Processing Therapy

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Individual Cognitive Processing TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials
203
Recruited
26,900+

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