NCT04617132

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

October 30, 2020

Last Update Submit

February 10, 2023

Conditions

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Assessed via participant attendance and clinician survey about technological difficulties

    Weekly (Week 1-8)

Secondary Outcomes (4)

  • Acceptance & Satisfaction

    Week 8

  • Relationship & Interactions

    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 Outcomes (1)

  • Demographics

    Week 1

Study Arms (1)

Online Mindfulness Group

Families with PPDA receiving evidence-based MBCT/MBSR intervention

Behavioral: MBCT/MBSR

Interventions

MBCT/MBSRBEHAVIORAL

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.

Online Mindfulness Group

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Invited from a tertiary mental health clinic

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Mental Health Program, BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (1)

  • Tabi K, Bhullar M, Fantu L, Shulman B, Dueck R, Hippman C, Ryan D, Stewart SE. Feasibility of online mindfulness-based interventions for families affected with postpartum depression and anxiety: study protocol. BMJ Open. 2022 Sep 7;12(9):e051935. doi: 10.1136/bmjopen-2021-051935.

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • S. Evelyn Stewart

    British Columbia Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 5, 2020

Study Start

October 20, 2020

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations