Postpartum DepressionNCT04928742
Online PHN CBT for PPD
A study testing Group Cognitive Behavioural Therapy (CBT) in people with Postpartum Depression, run by McMaster University at 1 site in Canada.
Trial summary
The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Group Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2020to 2 Mar 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible women will be >18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between of 10 or more and meet diagnostic criteria for current major depressive disorder on the Mini International Neuropsychiatric Interview-Plus (MINI-Plus). They will also all be within 12 months of delivering an infant.
Who cannot join
- In order to increase the relevance and generalizability of our findings, women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder. These are predictors of significant difficulty participating in therapy groups and/or non-response to CBT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Public Health Nurse-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression
The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.
Read the detailed description
A prospective, 1-site, parallel group, RCT (1:1 ratio) in which outcome assessors and data analysts will be blinded to maternal treatment will be used to compare online PHN-delivered group CBT for PPD to postnatal care as usual.
The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.
Women in the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
- Conditions
- Postpartum Depression
- Being tested
- Group Cognitive Behavioural Therapy (CBT)
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behavioural Therapy (CBT)Behavioural
The 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (9-week online CBT group) | Experimental | Participants assigned to the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week. All participants in the treatment group will be mailed a hardcopy of the program manual. Receives: Behavioral: Group Cognitive Behavioural Therapy (CBT) |
| Control (treatment as usual) | No intervention | The control group will receive standard postnatal care from Niagara Region Public Health, their obstetrician, midwife, and/or family physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Depressive Symptoms
Edinburgh Postnatal Depression Scale (EPDS): The EPDS is the 10-item gold standard measure of maternal depressive symptoms. A score >12 is consistent with PPD and changes in scores of 4 or more points are indicative of clinically significant improvement.
Measured: 9 weeks
Secondary outcomes (17)
Anxiety
Penn State Worry Questionnaire (PSWQ): The PSWQ is a 16-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD.
Measured: 9 weeks
Mother-Infant Bonding
Postpartum Bonding Questionnaire: The Postpartum Bonding Questionnaire is a 25 item maternal report scale that is designed to detect disorders of the mother-infant relationship on four subscales: bonding, rejection and anger, infant-focused anxiety, and incipient abuse.
Measured: 9 weeks
Social Support
The Social Provisions Scale: The SPS is a 24-item self-report measures of the degree to which an individual's social relationships provide support.
Measured: 9 weeks
Social Support
The Social Provisions Scale: The SPS is a 24-item self-report measures of the degree to which an individual's social relationships provide support.
Measured: 6 months
Relationship with Partner
Dyadic Adjustment Scale: a 32 item scale that assesses partner relationship on 4 subscales: dyadic consensus, affectional expression, dyadic satisfaction and dyadic cohesion.
Measured: 6 months
Relationship with Partner
Dyadic Adjustment Scale: a 32 item scale that assesses partner relationship on 4 subscales: dyadic consensus, affectional expression, dyadic satisfaction and dyadic cohesion.
Measured: 9 weeks
Infant Temperament
Infant Behavior Questionnaire-Revised (very short form): Temperament refers to the ways individuals think, behave, and react and is heavily influenced by the degree to which infants and toddlers can regulate their emotions. Factor analysis of the domains of temperament assessed by the IBQ-R (VSF) indicates that they are consistent with 3 broad dimensions of temperament: emotion regulation, negative affectivity, and extraversion. These subscales have demonstrated good internal consistency and inter-rater reliability between parents. Mothers and fathers will complete the IBQ-R on their infants immediately before treatment, right after treatment, and at 6 months afterward.
Measured: 9 weeks
Infant Temperament
Infant Behavior Questionnaire-Revised (very short form): Temperament refers to the ways individuals think, behave, and react and is heavily influenced by the degree to which infants and toddlers can regulate their emotions. Factor analysis of the domains of temperament assessed by the IBQ-R (VSF) indicates that they are consistent with 3 broad dimensions of temperament: emotion regulation, negative affectivity, and extraversion. These subscales have demonstrated good internal consistency and inter-rater reliability between parents. Mothers and fathers will complete the IBQ-R on their infants immediately before treatment, right after treatment, and at 6 months afterward.
Measured: 6 months
Cost Effectiveness - costs
Cost-effectiveness will be measured using incremental cost per quality-adjusted life year ratio.
Costs: Canadian Community Health Survey and the Service Use and Resources Form. We will measure resources consumed over the trial period from the perspective of public health care payer. Corresponding unit costs will be calculated using provincial or other standard billing rates.
Measured: 9 weeks
Cost Effectiveness - QALY
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. Its validity in measuring the impact of depression is established. Its Canadian scoring algorithm will be used to convert the five responses to health utility at each measurement occasion.
Measured: 9 weeks
Cost Effectiveness - costs
Cost-effectiveness will be measured using incremental cost per quality-adjusted life year ratio.
Costs: Healthcare resource utilization data will be collected using a questionnaire based on the Canadian Community Health Survey and the Service Use and Resources Form. We will measure resources consumed over the trial period from the perspective of public health care payer. Corresponding unit costs will be calculated using provincial or other standard billing rates.
Measured: 6 months
Cost Effectiveness - QALY
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. Its validity in measuring the impact of depression is established. Its Canadian scoring algorithm will be used to convert the five responses to health utility at each measurement occasion.
Measured: 6 months
Maternal Major Depressive Disorder
Mini International Neuropsychiatric Interview (MINI): The MINI is a validated structured diagnostic interview used to assess psychiatric disorders consistent with the DSM-IV. It demonstrates very good agreement with the Structured Clinical Interview for DSM-IV and strong inter-rater reliability has been noted.
Major Depressive Disorder Module: Our primary outcome (recurrence) will be assessed at 6 months post-treatment, but in order to compare trajectories of recovery/recurrence/relapse, we will assess these outcomes at baseline, 9 weeks, and 6 months. Relapse will be assessed at 6 months post-CBT completion.
Our primary outcome for maternal depression using the MINI will be the proportion of women who meet MINI current MDD diagnostic criteria at 6 months.
Measured: 6 months
Anxiety
Penn State Worry Questionnaire (PSWQ): The PSWQ is a 16-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD.
Measured: 6 months
Mother-Infant Bonding
Postpartum Bonding Questionnaire: The Postpartum Bonding Questionnaire is a 25 item maternal report scale that is designed to detect disorders of the mother-infant relationship on four subscales: bonding, rejection and anger, infant-focused anxiety, and incipient abuse.
Measured: 6 months
Maternal Major Depressive Disorder
Mini International Neuropsychiatric Interview (MINI): The MINI is a validated structured diagnostic interview used to assess psychiatric disorders consistent with the DSM-IV. It demonstrates very good agreement with the Structured Clinical Interview for DSM-IV and strong inter-rater reliability has been noted.
Major Depressive Disorder Module: Our primary outcome (recurrence) will be assessed at 6 months post-treatment, but in order to compare trajectories of recovery/recurrence/relapse, we will assess these outcomes at baseline, 9 weeks, and 6 months. Relapse will be assessed at 6 months post-CBT completion.
Our primary outcome for maternal depression using the MINI will be the proportion of women who meet MINI current MDD diagnostic criteria at 6 months.
Measured: 9 weeks
Maternal Depressive Symptoms
Edinburgh Postnatal Depression Scale (EPDS): The EPDS is the 10-item gold standard measure of maternal depressive symptoms. A score >12 is consistent with PPD and changes in scores of 4 or more points are indicative of clinically significant improvement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start30 Mar 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 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.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to the treatment group (online PHN-delivered group CBT) or the control group (treatment as usual).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 159 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
- NCT04928742
- Sponsor's protocol ID
- OnlinePHNCBT
- Status last verified
- Jul 2022
- First submitted
- 9 Apr 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 42383885Huh K, Layton H, Savoy CD, Ferro MA, Bieling PJ, Hicks A, Van Lieshout RJ. Online Public Health Nurse-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial During the COVID-19 Pandemic. J Clin Psychiatry. 2023 Jul 24;84(5):22m14726. doi: 10.4088/JCP.22m14726.
PubMed 37498661
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Public Health Nurse-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression
- ClinicalTrials.gov ID
- NCT04928742
- Acronym / sponsor ID
- OnlinePHNCBT
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 16 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.
The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.
Detailed description
A prospective, 1-site, parallel group, RCT (1:1 ratio) in which outcome assessors and data analysts will be blinded to maternal treatment will be used to compare online PHN-delivered group CBT for PPD to postnatal care as usual.
The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.
Women in the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to the treatment group (online PHN-delivered group CBT) or the control group (treatment as usual).
| Arm | Type | Receives |
|---|---|---|
| Treatment (9-week online CBT group) | Experimental | Behavioral: Group Cognitive Behavioural Therapy (CBT)Participants assigned to the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week. All participants in the treatment group will be mailed a hardcopy of the program manual. |
| Control (treatment as usual) | No intervention | –The control group will receive standard postnatal care from Niagara Region Public Health, their obstetrician, midwife, and/or family physician. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible women will be >18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between of 10 or more and meet diagnostic criteria for current major depressive disorder on the Mini International Neuropsychiatric Interview-Plus (MINI-Plus). They will also all be within 12 months of delivering an infant.
Key exclusion criteria (1 listed)
- In order to increase the relevance and generalizability of our findings, women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder. These are predictors of significant difficulty participating in therapy groups and/or non-response to CBT.
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 |
|---|---|---|
| Group Cognitive Behavioural Therapy (CBT)The 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week. | Behavioural | Treatment (9-week online CBT group) |
Primary outcome
Maternal Depressive Symptoms
Time frame: 9 weeks
Edinburgh Postnatal Depression Scale (EPDS): The EPDS is the 10-item gold standard measure of maternal depressive symptoms. A score >12 is consistent with PPD and changes in scores of 4 or more points are indicative of clinically significant improvement.
17 secondary outcomes
Anxiety
Time frame: 9 weeks
Mother-Infant Bonding
Time frame: 9 weeks
Social Support
Time frame: 9 weeks
Social Support
Time frame: 6 months
Relationship with Partner
Time frame: 6 months
Relationship with Partner
Time frame: 9 weeks
Infant Temperament
Time frame: 9 weeks
Infant Temperament
Time frame: 6 months
Cost Effectiveness - costs
Time frame: 9 weeks
Cost Effectiveness - QALY
Time frame: 9 weeks
Cost Effectiveness - costs
Time frame: 6 months
Cost Effectiveness - QALY
Time frame: 6 months
Maternal Major Depressive Disorder
Time frame: 6 months
Anxiety
Time frame: 6 months
Mother-Infant Bonding
Time frame: 6 months
Maternal Major Depressive Disorder
Time frame: 9 weeks
Maternal Depressive Symptoms
Time frame: 6 months
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 25 Jul 2022.
- 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 37498661Huh K, Layton H, Savoy CD, Ferro MA, Bieling PJ, Hicks A, Van Lieshout RJ. Online Public Health Nurse-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial During the COVID-19 Pandemic. J Clin Psychiatry. 2023 Jul 24;84(5):22m14726. doi: 10.4088/JCP.22m14726.
- Individual participant dataSharing planned: No
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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 Group Cognitive Behavioural Therapy (CBT) 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 1 inclusion and 1 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 25 Jul 2022. 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?
Maternal Depressive Symptoms (time frame: 9 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 NCT04928742, 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 25 Jul 2022.