Online Public Health Nurse Delivered 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshops for Postpartum Depression Symptoms: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 119
- Locations
- 2
- Primary Endpoint
- Number of participants who complete the intervention (adherence)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •have infant <12 months at time of recruitment
- •fluent in written/spoken English
Exclusion Criteria
- •current bipolar, psychotic and/or substance use disorders
Outcomes
Primary Outcomes
Number of participants who complete the intervention (adherence)
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
75% of participants complete all data collection procedures at all time points
Number of participants who complete study (retention)
Time Frame: 6 months
75% of participants remain enrolled in the study until completion
Secondary Outcomes
- Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)(3 months)
Investigators
Ryan Van Lieshout, MD, PhD
Associate Professor
McMaster University