Clinical trial NCT05314361: Public Health Nurse-Delivered 1-Day CBT Workshops Pilot
Official title: Online Public Health Nurse Delivered 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshops for Postpartum Depression Symptoms: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants recruited in recruitment period
timeFrame: 5 months
measure: Number of participants who complete all data collection procedures
timeFrame: 6 months
measure: Number of participants who complete study (retention)
timeFrame: 6 months
measure: Number of participants who complete the intervention (adherence)
timeFrame: 6 months
Secondary outcomes:
measure: Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 3 months
Other outcomes:
measure: GAD-7
timeFrame: 3 months
measure: GAD-7
timeFrame: 6 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 3 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 6 months
measure: Parenting Stress Index (PSI-SF)
timeFrame: 3 months
measure: Parenting Stress Index (PSI-SF)
timeFrame: 6 months
measure: The Postpartum Bonding Questionnaire (PBQ)
timeFrame: 3 months
measure: The Postpartum Bonding Questionnaire (PBQ)
timeFrame: 6 months
measure: Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
timeFrame: 3 months
measure: Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)
timeFrame: 6 months
measure: EQ-5D-5L
timeFrame: 3 months
measure: EQ-5D-5L
timeFrame: 6 months
measure: Healthcare Resource Utilization Questionnaire
timeFrame: 3 months
measure: Healthcare Resource Utilization Questionnaire
timeFrame: 6 months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 1 week
measure: CBT Skills Questionnaire (CBTSQ)
timeFrame: 3 months
measure: CBT Skills Questionnaire (CBTSQ)
timeFrame: 6 months
measure: Working Alliance Inventory (WAI-SR)
timeFrame: 1 week
measure: Mini International Neuropsychiatric Interview - Major Depressive Disorder Module
timeFrame: 3 months
measure: Mini International Neuropsychiatric Interview - Major Depressive Disorder Module
timeFrame: 6 months
measure: Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 months
measure: Group cohesion - Therapeutic Factors Inventory - 8 item
timeFrame: 1 week
measure: Development and testing of treatment fidelity measure
timeFrame: 12 weeks
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: