Postpartum DepressionNCT04934488
Online Peer-Delivered 1-Day CBT Workshops for PPD
A study testing Online Peer-Delivered 1-Day CBT-Based Workshop in people with Postpartum Depression, run by McMaster University at 1 site in Canada.
Trial summary
A parallel group RCT with experimental (immediate workshop) and waitlist control (treatment 12 weeks later) groups will address our objectives. All participants will be asked to complete study questionnaires at baseline (T1, 3 weeks before the intervention/first workshop) and 12 weeks later (T2, just prior to the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Online Peer-Delivered 1-Day CBT-Based Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jun 2021to 18 Feb 2022
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- reside in Ontario
- have an infant <12 months old
- 18 years or older
- EPDS score 10 or more
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online 1-Day Peer-Delivered Cognitive Behavioural Therapy (CBT)-Based Workshops for Postpartum Depression
A parallel group RCT with experimental (immediate workshop) and waitlist control (treatment 12 weeks later) groups will address our objectives. All participants will be asked to complete study questionnaires at baseline (T1, 3 weeks before the intervention/first workshop) and 12 weeks later (T2, just prior to the waitlist control/second workshop). Workshops will be delivered by trained peer leaders (women who have recovered from PPD). The study will aim to determine if online 1-day CBT-based workshops for PPD delivered by trained lay peers added to care as usual during the COVID-19 pandemic: (1) can improve PPD more than usual care alone, (2) are cost-effective, (3) can reduce the impact of common comorbidities and complications of PPD including anxiety, partner-relationship discord, social support, infant temperament, parenting stress, and poorer mother-infant attachment.
Read the detailed description
The COVID-19 pandemic has further exposed vulnerabilities in social and economic systems that lead to inequalities for mothers with mental health problems and their children, worsening unintended systematic biases that exist within the healthcare system. Women with postpartum depression (PPD) are experiencing substantial worry (1), isolation, loneliness, and insomnia (2), all of which have increased levels of PPD(3,4). Mothers now have more responsibilities than ever before, providing care to their infants and toddlers, educating their older children, managing households, and supporting their partners. They are also profoundly worried about job losses, reduced income, and food insecurity (5), all of which have disrupted family routines and increased levels of partner conflict and rates of intimate partner violence.(6)
Postpartum depression (PPD) typically affects up to 1 in 5 women (7-9) and increases the risk of later depressive episodes (10), parenting problems (11), poor mother-infant attachment (12), and emotional, behavioural, and school problems in offspring (13,14). A single case of PPD has been estimated to cost as much as $150,000 over the lifespan (15), or $57 billion for each annual cohort of Canadian births.
Even under ideal conditions, the healthcare system is poorly equipped to provide care for problems requiring urgent psychotherapy like PPD (e.g., just 1 in 10 women with PPD receive evidence-based care) (16). Barriers include women's preference for psychotherapy over medication, a lack of time, and a reluctance to travel to regular appointments (17,18). During the pandemic, the healthcare system has become even less able to help these women as public health units that previously supported the mental health of mothers have shifted their priorities to direct COVID response. Moreover, social distancing recommendations aimed at reducing COVID-19 risk have inadvertently increased psychological distress (19) and decreased access to resources that protect against PPD including social and practical support from family, friends, and professionals.
Peer administered interventions (PAIs - those delivered by recovered former patients) are increasingly recognized as potentially effective alternatives to traditional mental health care services (21). Such treatments capitalize on the fact that in the case of psychotherapy, it is not clear that the level of training predicts treatment quality or outcome (22,23) for patients. Depression is an appropriate target for PAIs because it is relatively common, there is substantial unmet treatment need, and recovery rates are high, suggesting that peers will be widely available (21). The few studies that have examined the impact of PAIs for depression suggest they can be effective in both the short and long term but are most effective if: a) they are delivered by peers alone, and b) structured and based on evidence-based treatments (rather than providing non-specific support) (21). In the context of the COVID-19 pandemic peer-delivered interventions are particularly appealing, considering redeployment and re-prioritizing of healthcare providers and services to focus on responding to the pandemic.
Only interventions that are considered safe and that can be rapidly upscaled can have an impact on PPD at the population level (24). Ideal large-scale interventions for PPD during the COVID-19 pandemic are not only safe (i.e., delivered online), but brief, utilize the treatments most preferred by women (i.e., non-pharmacological), reduce barriers to accessibility (i.e., self-referred), provide skills that can be used over the long-term, and delivered in large groups to increase social support. At present time, no interventions exist that meet all of these criteria.
Research Questions Primary Research Question: Can Online 1-Day CBT-Based Workshops for PPD delivered by trained lay peers added to care as usual during the COVID-19 pandemic improve PPD more than usual care alone? Secondary Research Question: Are the workshops cost-effective? Tertiary Research Question: Can these workshops reduce the impact of the common comorbidities and complications of PPD (anxiety, partner relationship discord, social support, infant temperament, parenting stress, and poorer mother-infant attachment)?
Design A parallel group RCT with experimental (immediate workshop) and waitlist control (treatment 12 weeks later) groups will address our objectives. All participants will be asked to complete study questionnaires at baseline (T1, 3 weeks before the intervention/first workshop) and 12 weeks later (T2, just prior to the waitlist control/second workshop). Peers delivering groups will be randomly assigned to workshops and not notified of group status.
Intervention: The experimental (immediate workshop) group will receive the online workshop at baseline (T1), and the control (waitlist) group will receive the intervention twelve weeks later. Both groups can also receive care as usual from their healthcare providers.
The online workshop was developed by the NPI, Ryan Van Lieshout (a perinatal psychiatrist who has developed and tested effective brief group CBT for PPD interventions), Peter Bieling (author of the world's leading group CBT manual), and June Brown (developer of 1-Day CBT-Based workshops for depression in the UK). It is a day-long intervention delivered in 4 modules. Each participant is given a professionally designed manual (Attached) to facilitate learning. Weekly reminder emails are sent for 8 weeks after workshop completion to encourage practice. The investigators also provide a list of PPD resources and a copy of the Canadian Practice Guidelines for the Treatment of PPD (written by NPI).
Lay peers who have recovered from PPD will be recruited (n=5) to be trained to deliver the workshops. The investigators will utilize the CBT training program and screening and safety protocols (e.g., handling suicidality, child safety issues) developed in the context of a previous study where a psychologist and psychotherapist delivered the 1-Day CBT workshops.
Given the situation with COVID-19, the investigators will run the CBT workshops virtually via ZOOM.
Randomization: Women will undergo block randomization to the experimental or waitlist control group using permuted block sizes of 4, 6, and 8. The randomization scheme will be generated in the statistical computing program R. The randomization of participants will be delivered to the research coordinator via the online REDCap (Research Electronic Data Capture) system. The investigators will track reasons for loss to follow-up.
Recruitment: The investigators will recruit participants via social and online media, our public health and community partners, midwifery groups, and obstetrical and family practices.
- Conditions
- Postpartum Depression
- Being tested
- Online Peer-Delivered 1-Day CBT-Based Workshop
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Peer-Delivered 1-Day CBT-Based WorkshopBehavioural
It is a day-long intervention delivered in 4 modules. Each participant is given a professionally designed manual to facilitate learning. 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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | The experimental (immediate workshop) group will receive the online workshop at baseline (T1). The experimental group will also receive care as usual from their healthcare providers. Receives: Behavioral: Online Peer-Delivered 1-Day CBT-Based Workshop |
| Waitlist Control | Other | The waitlist control group will receive care from usual healthcare providers and will receive the intervention at the conclusion of the study period (T2, 12 weeks after enrollment). Receives: Behavioral: Online Peer-Delivered 1-Day CBT-Based Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The Edinburgh Postnatal Depression Scale (EPDS) is the 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms.. A score ≥13 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change (31).
Measured: 12 weeks
Secondary outcomes (9)
Cost-Effectiveness - Costs
Cost-effectiveness will be measured using incremental cost per quality-adjusted life year ratio.
Costs: Healthcare resource utilization data (including mental health service use) will be collected using a questionnaire based on the Canadian Community Health Survey and the Service Use and Resources Form, adapted for the postpartum period and used in previous PPD research. Corresponding unit costs will be calculated using provincial or other standard billing rates.
Measured: 12 weeks
Cost-Effectiveness - Quality Adjusted Life Year
Cost-effectiveness will be measured using incremental cost per quality-adjusted life year ratio.
Quality-Adjusted Life Year (QALY): The EQ-5D-5L is a utility-based health-related quality of life instrument consisting of five questions covering depression/anxiety, usual activities, self-care, pain/ discomfort, and mobility. For each participant, a QALY will be calculated by multiplying the health utility for the matching time period (i.e., the area under the curve approach).
Measured: 12 weeks
Anxiety
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) (32) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. Items are scored on a 4-point scale from 0 to 3, with a higher score indicating an increased risk of GAD. The GAD-7 will be examined as both a continuous and dichotomous outcome, where a cutoff of ≥11 defined clinically important levels of anxiety symptoms.
Measured: 12 weeks
Mother-Infant Bonding
Postpartum Bonding Questionnaire (PBQ) is a 25-item measure that will be used to assess 3 aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety. Each item is scored on a scale of 0-5, with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicating bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.
Measured: 12 weeks
Social Support
The Social Provisions Scale (SPS) is a 24-item self-report measure of the degree to which the social relationships within an individual's life provide support. Items are scored on a 4-point scale (1-4) and total scores range from 24-96, with higher scores indicating more perceived support.
Measured: 12 weeks
Partner Relationship Quality
The Dyadic Adjustment Scale is a 32-item questionnaire that measures an individual's perceptions of his/her relationship with an intimate partner. Questions are answered on 6-point scales. Totals cores vary from 0-151 with higher scores indicating better perceived dyadic relationship.
Measured: 12 weeks
Parenting stress
The Parenting Stress Index (short form) is a 36-item parent self-report measure that identifies potentially dysfunctional parent-child systems on three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. The measure also produces a total score that is an indication of overall level of stress a person is feeling in their role as a parent. Higher scores indicate higher levels of stress.
Measured: 12 weeks
Infant Temperament
The Infant Behaviour Questionnaire-Revised (Very Short Form) (IBQR) is a parent-report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assesses 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items, and Orienting/Regulatory Capacity with 12 items; higher scores indicate greater alignment with the domain.
Measured: 12 weeks
Client Satisfaction
Satisfaction with the workshop will be assessed using the CSQ-8, an 8-item self-report scale. Items are scored using a 4-point likert-scale with total scores ranging from 8-32. Higher scores indicated higher satisfaction. The CSQ-8 will be analyzed using the continuous scale score for participants who complete the intervention in the experimental arm of the trial.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start7 Jun 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Van Lieshout, MD, PhD, McMaster University
- Investigators
- Ryan Van Lieshout, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934488
- Sponsor's protocol ID
- Peer1DayCBT
- Status last verified
- Feb 2023
- First submitted
- 13 May 2021
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
George KV, Savoy CD, Layton H, Bieling PJ, Van Lieshout RJ. Prevalence of Comorbid Postpartum Depression and Anxiety in Birthing Parents Seeking Treatment for Postpartum Depression: Prevalence de la presence comorbide de la depression et de l'anxiete post-partum chez les parents ayant accouche qui ont consulte en raison de la depression post-partum. Can J Psychiatry. 2026 Jul 1:7067437261462698. doi: 10.1177/07067437261462698. Online ahead of print.
PubMed 42383885Drage JT, Layton H, Varambally M, Jack SM, Van Lieshout RJ. Birthing parents' perceptions of an online peer-delivered 1-day cognitive-behavioural therapy-based workshop for postpartum depression added to usual care. Midwifery. 2025 Apr;143:104319. doi: 10.1016/j.midw.2025.104319. Epub 2025 Jan 30.
PubMed 39923292
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online 1-Day Peer-Delivered Cognitive Behavioural Therapy (CBT)-Based Workshops for Postpartum Depression
- ClinicalTrials.gov ID
- NCT04934488
- Acronym / sponsor ID
- Peer1DayCBT
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 22 Jun 2021 (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.
A parallel group RCT with experimental (immediate workshop) and waitlist control (treatment 12 weeks later) groups will address our objectives. All participants will be asked to complete study questionnaires at baseline (T1, 3 weeks before the intervention/first workshop) and 12 weeks later (T2, just prior to the waitlist control/second workshop). Workshops will be delivered by trained peer leaders (women who have recovered from PPD). The study will aim to determine if online 1-day CBT-based workshops for PPD delivered by trained lay peers added to care as usual during the COVID-19 pandemic: (1) can improve PPD more than usual care alone, (2) are cost-effective, (3) can reduce the impact of common comorbidities and complications of PPD including anxiety, partner-relationship discord, social support, infant temperament, parenting stress, and poorer mother-infant attachment.
Detailed description
The COVID-19 pandemic has further exposed vulnerabilities in social and economic systems that lead to inequalities for mothers with mental health problems and their children, worsening unintended systematic biases that exist within the healthcare system. Women with postpartum depression (PPD) are experiencing substantial worry (1), isolation, loneliness, and insomnia (2), all of which have increased levels of PPD(3,4). Mothers now have more responsibilities than ever before, providing care to their infants and toddlers, educating their older children, managing households, and supporting their partners. They are also profoundly worried about job losses, reduced income, and food insecurity (5), all of which have disrupted family routines and increased levels of partner conflict and rates of intimate partner violence.(6)
Postpartum depression (PPD) typically affects up to 1 in 5 women (7-9) and increases the risk of later depressive episodes (10), parenting problems (11), poor mother-infant attachment (12), and emotional, behavioural, and school problems in offspring (13,14). A single case of PPD has been estimated to cost as much as $150,000 over the lifespan (15), or $57 billion for each annual cohort of Canadian births.
Even under ideal conditions, the healthcare system is poorly equipped to provide care for problems requiring urgent psychotherapy like PPD (e.g., just 1 in 10 women with PPD receive evidence-based care) (16). Barriers include women's preference for psychotherapy over medication, a lack of time, and a reluctance to travel to regular appointments (17,18). During the pandemic, the healthcare system has become even less able to help these women as public health units that previously supported the mental health of mothers have shifted their priorities to direct COVID response. Moreover, social distancing recommendations aimed at reducing COVID-19 risk have inadvertently increased psychological distress (19) and decreased access to resources that protect against PPD including social and practical support from family, friends, and professionals.
Peer administered interventions (PAIs - those delivered by recovered former patients) are increasingly recognized as potentially effective alternatives to traditional mental health care services (21). Such treatments capitalize on the fact that in the case of psychotherapy, it is not clear that the level of training predicts treatment quality or outcome (22,23) for patients. Depression is an appropriate target for PAIs because it is relatively common, there is substantial unmet treatment need, and recovery rates are high, suggesting that peers will be widely available (21). The few studies that have examined the impact of PAIs for depression suggest they can be effective in both the short and long term but are most effective if: a) they are delivered by peers alone, and b) structured and based on evidence-based treatments (rather than providing non-specific support) (21). In the context of the COVID-19 pandemic peer-delivered interventions are particularly appealing, considering redeployment and re-prioritizing of healthcare providers and services to focus on responding to the pandemic.
Only interventions that are considered safe and that can be rapidly upscaled can have an impact on PPD at the population level (24). Ideal large-scale interventions for PPD during the COVID-19 pandemic are not only safe (i.e., delivered online), but brief, utilize the treatments most preferred by women (i.e., non-pharmacological), reduce barriers to accessibility (i.e., self-referred), provide skills that can be used over the long-term, and delivered in large groups to increase social support. At present time, no interventions exist that meet all of these criteria.
Research Questions Primary Research Question: Can Online 1-Day CBT-Based Workshops for PPD delivered by trained lay peers added to care as usual during the COVID-19 pandemic improve PPD more than usual care alone? Secondary Research Question: Are the workshops cost-effective? Tertiary Research Question: Can these workshops reduce the impact of the common comorbidities and complications of PPD (anxiety, partner relationship discord, social support, infant temperament, parenting stress, and poorer mother-infant attachment)?
Design A parallel group RCT with experimental (immediate workshop) and waitlist control (treatment 12 weeks later) groups will address our objectives. All participants will be asked to complete study questionnaires at baseline (T1, 3 weeks before the intervention/first workshop) and 12 weeks later (T2, just prior to the waitlist control/second workshop). Peers delivering groups will be randomly assigned to workshops and not notified of group status.
Intervention: The experimental (immediate workshop) group will receive the online workshop at baseline (T1), and the control (waitlist) group will receive the intervention twelve weeks later. Both groups can also receive care as usual from their healthcare providers.
The online workshop was developed by the NPI, Ryan Van Lieshout (a perinatal psychiatrist who has developed and tested effective brief group CBT for PPD interventions), Peter Bieling (author of the world's leading group CBT manual), and June Brown (developer of 1-Day CBT-Based workshops for depression in the UK). It is a day-long intervention delivered in 4 modules. Each participant is given a professionally designed manual (Attached) to facilitate learning. Weekly reminder emails are sent for 8 weeks after workshop completion to encourage practice. The investigators also provide a list of PPD resources and a copy of the Canadian Practice Guidelines for the Treatment of PPD (written by NPI).
Lay peers who have recovered from PPD will be recruited (n=5) to be trained to deliver the workshops. The investigators will utilize the CBT training program and screening and safety protocols (e.g., handling suicidality, child safety issues) developed in the context of a previous study where a psychologist and psychotherapist delivered the 1-Day CBT workshops.
Given the situation with COVID-19, the investigators will run the CBT workshops virtually via ZOOM.
Randomization: Women will undergo block randomization to the experimental or waitlist control group using permuted block sizes of 4, 6, and 8. The randomization scheme will be generated in the statistical computing program R. The randomization of participants will be delivered to the research coordinator via the online REDCap (Research Electronic Data Capture) system. The investigators will track reasons for loss to follow-up.
Recruitment: The investigators will recruit participants via social and online media, our public health and community partners, midwifery groups, and obstetrical and family practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Online Peer-Delivered 1-Day CBT-Based WorkshopThe experimental (immediate workshop) group will receive the online workshop at baseline (T1). The experimental group will also receive care as usual from their healthcare providers. |
| Waitlist Control | Other | Behavioral: Online Peer-Delivered 1-Day CBT-Based WorkshopThe waitlist control group will receive care from usual healthcare providers and will receive the intervention at the conclusion of the study period (T2, 12 weeks after enrollment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- reside in Ontario
- have an infant <12 months old
- 18 years or older
- EPDS score 10 or more
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Online Peer-Delivered 1-Day CBT-Based WorkshopIt is a day-long intervention delivered in 4 modules. Each participant is given a professionally designed manual to facilitate learning. 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. | Behavioural | Immediate Treatment, Waitlist Control |
Primary outcome
Depression
Time frame: 12 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is the 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms.. A score ≥13 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change (31).
9 secondary outcomes
Cost-Effectiveness - Costs
Time frame: 12 weeks
Cost-Effectiveness - Quality Adjusted Life Year
Time frame: 12 weeks
Anxiety
Time frame: 12 weeks
Mother-Infant Bonding
Time frame: 12 weeks
Social Support
Time frame: 12 weeks
Partner Relationship Quality
Time frame: 12 weeks
Parenting stress
Time frame: 12 weeks
Infant Temperament
Time frame: 12 weeks
Client Satisfaction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 42383885George KV, Savoy CD, Layton H, Bieling PJ, Van Lieshout RJ. Prevalence of Comorbid Postpartum Depression and Anxiety in Birthing Parents Seeking Treatment for Postpartum Depression: Prevalence de la presence comorbide de la depression et de l'anxiete post-partum chez les parents ayant accouche qui ont consulte en raison de la depression post-partum. Can J Psychiatry. 2026 Jul 1:7067437261462698. doi: 10.1177/07067437261462698. Online ahead of print.
- Derived from this study: PubMed 39923292Drage JT, Layton H, Varambally M, Jack SM, Van Lieshout RJ. Birthing parents' perceptions of an online peer-delivered 1-day cognitive-behavioural therapy-based workshop for postpartum depression added to usual care. Midwifery. 2025 Apr;143:104319. doi: 10.1016/j.midw.2025.104319. Epub 2025 Jan 30.
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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.
Ryan Van Lieshout, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Peer-Delivered 1-Day CBT-Based Workshop in people with Postpartum Depression, run by McMaster University 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression (time frame: 12 weeks). 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 NCT04934488, which also lists 2 linked publications.
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 27 Feb 2023.