Public Health Nurse-Delivered 1-Day CBT Workshops Pilot
- Conditions
- Postpartum Depression
- Interventions
- Behavioral: 1-Day Cognitive Behavioural Therapy-Based Workshop
- Registration Number
- NCT05314361
- Lead Sponsor
- McMaster University
- Brief Summary
Public Health Nurses received training to deliver a day-long Cognitive Behavioural Therapy-based workshop for treating postpartum depression. Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months.
The study will aim to assess the feasibility of our methods and estimate the treatment effect of the primary outcome in preparation for a larger RCT. Objectives include:
* Recruit and randomize 96 participants within 5 months
* Questionnaire completion - 75% of participants complete all three questionnaires and structured interviews
* Retention - 75% of participants remain in study until completion
* 75% of participants in treatment group complete the intervention
* Estimate treatment effect and variance
- Detailed Description
Postpartum depression (PPD) is one of the most common complications of childbirth, affecting 1 in 5 mothers. Left untreated, it increases the risk of future depressive episodes and can have profound effects on offspring. A single case of PPD has been estimated to cost as much as $150,000 over the lifespan, or $3 billion for each annual cohort of Canadian births.
Current clinical practice guidelines (including those written by the NPA) recommend evidence-based psychotherapies (e.g., cognitive behavioural therapy (CBT)) as 1st-line treatments for the vast majority of mothers with PPD. The key role that psychotherapy plays in the treatment of PPD is further emphasized by the US Preventive Services Task Force which recommends universal PPD screening, but "only when CBT or other evidence-based counseling is available."
While treating PPD can reduce its adverse effects, safe, timely, accessible interventions are essential to optimizing outcomes. However, only treatments that can be upscaled can have an impact on PPD at the population level.
The delivery of psychotherapy in large groups (up to 30 participants) is a relatively new phenomenon, but may be capable of addressing mothers' needs, as well as treating PPD on the scale required to address its prevalence. Brief (i.e., 1-Day) interventions contain the core content of more comprehensive, evidence-based interventions, but their brevity makes them easier to disseminate beyond traditional treatment settings (e.g., in public health). 1-Day CBT-Based Workshops have been delivered by trained mental health professionals (psychologists, psychiatrists) to treat generalized anxiety disorder and depression in general population samples, and postpartum depression.
The purpose of this pilot study is to determine the feasibility of our study procedures and estimate the treatment effect and variance of the primary outcome in preparation for a larger RCT to determine the effectiveness of a Public Health Nurse-Delivered 1-Day Cognitive Behavioural Therapy-Based Workshop for postpartum depression.
A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants in both groups will complete all study questionnaires and be compared at baseline, and 3 and 6 months.
The experimental group will receive the Online 1-Day workshop (delivered by 2 PHNs) in addition to TAU, and the control group will receive TAU alone.
Participants will be mothers who have an infant under 12 months, who are 18 years or older, who are experiencing elevated symptoms of postpartum depression and who are free of current bipolar, psychotic and/or substance use disorders.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 119
- 18 years or older
- have infant <12 months at time of recruitment
- fluent in written/spoken English
- current bipolar, psychotic and/or substance use disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment - 1 Day CBT-Based Workshop 1-Day Cognitive Behavioural Therapy-Based Workshop Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered by two trained public health nurses in addition to receiving usual care.
- Primary Outcome Measures
Name Time Method Number of participants who complete the intervention (adherence) 6 months 75% of participants who are enrolled in the treatment group will complete the 1-Day CBT-based workshop
Number of participants recruited in recruitment period 5 months Recruit and randomize 96 participants within 5 months (48 treatment into four 1-day workshops (12 per workshop) and 48 control)
Number of participants who complete all data collection procedures 6 months 75% of participants complete all data collection procedures at all time points
Number of participants who complete study (retention) 6 months 75% of participants remain enrolled in the study until completion
- Secondary Outcome Measures
Name Time Method Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS) 3 months Estimate treatment effect of primary outcome for later RCT - The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score ≥13 is consistent with PPD and changes in scores \>4 are accepted as being indicative of clinically significant change.
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada