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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSt. Joseph's Healthcare Hamilton

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

severe depression/suicidality requiring acute intervention

medication changes in dose or type

Trial design

Design model

Single group

Treatments tested in this trial

  • Individual Cognitive Processing Therapy

    Behavioral

    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).

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Individual Cognitive Processing TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured through the recruitment period (up to 12 months)
2

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.

Time frame
Measured through the recruitment period (up to 12 months)
3

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.

Time frame
Measured during the treatment period, from the first to last session (up to 8 weeks)
4

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.

Time frame
Measured during the treatment period, from the first to last session (up to 8 weeks)

Secondary outcomes

1

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.

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).
2

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.

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).
3

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).

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).
4

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).

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).

Other outcomes

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