Postpartum DepressionNCT04617132
Online MBI for Families Affected by PPDA
An observational study of Postpartum Depression and Postpartum Anxiety, run by British Columbia Children's Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postpartum Depression, Postpartum Anxiety
- What is being tested?
- MBCT/MBSR
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2020to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: Invited from a tertiary mental health clinic
Who may be able to join
- 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.
Who cannot join
- Are younger than 19 years old.
- Women with PPDA assessed to currently have a substance use disorder, psychotic disorder, or suicidality.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Reproductive Mental Health Program, BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Being tested
- MBCT/MBSR
- Keywords
- Mindfulness
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT/MBSRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online Mindfulness Group | Families with PPDA receiving evidence-based MBCT/MBSR intervention Receives: Behavioral: MBCT/MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Assessed via participant attendance and clinician survey about technological difficulties
Measured: Weekly (Week 1-8)
Secondary outcomes (4)
Acceptance & Satisfaction
Self-report questionnaire completed by participants
Measured: Week 8
Relationship & Interactions
This is a newly developed self-report measure that explores couple interactions and relationship satisfaction
Measured: Week 1, 4, 8, and Follow-up
PHQ-9
Measured: Week 1, 4, 8, and Follow-up
GAD-7
Measured: Week 1, 4, 8, and Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start20 Oct 2020
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Tabi, British Columbia Children's Hospital
- Investigators
- S. Evelyn Stewart, Principal investigator, British Columbia Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617132
- Sponsor's protocol ID
- H20-01884
- Status last verified
- Feb 2023
- First submitted
- 30 Oct 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36691183
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness Groups for Families Affected by Postpartum Depression and Anxiety: Study Protocol
- ClinicalTrials.gov ID
- NCT04617132
- Acronym / sponsor ID
- H20-01884
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Keywords
- Mindfulness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- British Columbia Children's HospitalUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Mindfulness Group | – | Behavioral: MBCT/MBSRFamilies with PPDA receiving evidence-based MBCT/MBSR intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Invited from a tertiary mental health clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Are younger than 19 years old.
- Women with PPDA assessed to currently have a substance use disorder, psychotic disorder, or suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT/MBSRThis 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. | Behavioural | Online Mindfulness Group |
Primary outcome
Feasibility
Time frame: Weekly (Week 1-8)
Assessed via participant attendance and clinician survey about technological difficulties
4 secondary outcomes
Acceptance & Satisfaction
Time frame: Week 8
Relationship & Interactions
Time frame: Week 1, 4, 8, and Follow-up
PHQ-9
Time frame: Week 1, 4, 8, and Follow-up
GAD-7
Time frame: Week 1, 4, 8, and Follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Derived from this study: PubMed 36691183Tabi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Evelyn Stewart principal investigator
British Columbia Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression and Postpartum Anxiety, run by British Columbia Children's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Weekly (Week 1-8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.