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Public Health Nurse-Delivered 1-Day CBT Workshops Pilot

NCT05314361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2023-08-25

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

1-Day Cognitive Behavioural Therapy-Based Workshop

The Online Workshop is a day-long intervention delivered by two trained public health nurses consisting of 6 hours of instruction delivered in 4 modules. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays. Regular breaks are incorporated. Each participant is given a professionally designed manual to facilitate learning. We also provide a list of region-specific PPD resources and a copy of the Canadian Practice Guidelines for the treatment of PPD (written by the NPA).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2023-04-01
Completion
2023-04-01

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05314361 on ClinicalTrials.gov