Online MBI for Families Affected by PPDA

Online Mindfulness Groups for Families Affected by Postpartum Depression and Anxiety: Study Protocol

The aim of this study is to explore the feasibility of delivering clinical mindfulness groups for families affected with postpartum depression and anxiety (PPDA). Families with PPDA are a vulnerable population who already face challenges during the postpartum period, but now the Covid-19 era has brought extra challenges - lower availability of family members or support systems to help in person, older children at home as childcare facilities are closed, etc. Clinical mindfulness groups are now being run online to support this population, with the current barriers of having to stay at home. Through this study, we want to capture the challenges that both clinicians and participants might face using virtual platforms (e.g. technical difficulties), to see whether online delivery of clinical mindfulness groups is feasible.

Study Overview

• Status: Active, not recruiting
• Conditions: Postpartum Depression; Postpartum Anxiety
• Intervention / Treatment: Behavioral: MBCT/MBSR

Detailed Description

Postpartum depression and anxiety (PPDA) is a prevalent condition, affecting about every 1 in 5 families. This not only impacts the parent diagnosed with PPDA but also affects relationships with the rest of the family, ability to bond with her child, and can cause tension between the parents. Thus, it is important that steps are taken to effectively treat and support families affected by PPDA in a timely manner. On top of the struggles with a newborn baby, the Covid era has brought along some new challenges. One such challenge is that many healthcare providers and clinics have limited capacities or the care they provide may be limited due to lockdown and Covid-19. Another challenge is the decreased in-person support from family and other support systems, as well as having older children at home all the time due to childcare facilities being closed.

As it is important to offer this population some support, this study is being conducted to see if continuing the clinical groups and turning them onto a distant, online format would be possible, and if it would work for both clinicians and the postpartum population.

The aim of the study is to determine the feasibility of running online clinical mindfulness groups, particularly examining whether patients are able to access and continue with the online sessions. Feasibility will be assessed by frequency of technical difficulties faced by patients or clinicians and number of disruptions or episodes of parents leaving their screens (e.g. to calm their child), self-report items of how participants found attending online sessions and following the program, and attendance and drop-out rates. Secondary outcomes of this study include reasons for drop-outs, satisfaction and acceptability, couple interactions, and mental health outcomes.

The mindfulness groups will be rooted in the evidence-based 8-week programs, including Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), and adapted for this population needs. The mindfulness groups will run once a week, totalling 8 sessions over the course of 8 weeks. These groups will be run by trained clinicians and mindfulness facilitators and will be a part of the RMH clinical program.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Reproductive Mental Health Program, BC Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Invited from a tertiary mental health clinic

Description

Inclusion Criteria:

• Are able to read and write in English.
• Are in a cohabiting relationship - woman with PPDA and partner living together.
• Woman with PPDA has been diagnosed with MDD and/or GAD as per the DSM-5 criteria, up to 12 months postpartum.

Exclusion Criteria:

• Are younger than 19 years old.
• Women with PPDA assessed to currently have a substance use disorder, psychotic disorder, or suicidality.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Online Mindfulness Group; Families with PPDA receiving evidence-based MBCT/MBSR intervention	Behavioral: MBCT/MBSR; This intervention teaches the practice of mindfulness - being aware of the present moment without judgement - to help reduce the emotional reactivity to thoughts and bodily sensations, which prevents downward spirals into depression, anxiety, or fear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Assessed via participant attendance and clinician survey about technological difficulties	Weekly (Week 1-8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance & Satisfaction	Self-report questionnaire completed by participants	Week 8
Relationship & Interactions	This is a newly developed self-report measure that explores couple interactions and relationship satisfaction	Week 1, 4, 8, and Follow-up
PHQ-9		Week 1, 4, 8, and Follow-up
GAD-7		Week 1, 4, 8, and Follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Demographics questionnaire sent to participants	Week 1

Collaborators and Investigators

• Sponsor: British Columbia Children's Hospital
• Investigators: Principal Investigator: S. Evelyn Stewart, British Columbia Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2020
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression; Depression, Postpartum
• Other Study ID Numbers: H20-01884

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No