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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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

Eligibility

Primary outcome measure(s)

• Feasibility: Recruitment Rate — 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 — 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 — 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 — 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 — 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 — 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 — 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) — 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.

Trial sites (1)

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