Postpartum DepressionNCT03654261
1-Day CBT Workshops for PPD
A study testing Cognitive Behavioural Therapy in people with Postpartum Depression, run by McMaster University at 1 site in Canada.
Trial summary
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. 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?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 1 Oct 2020
- 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
- infant <12 months
- 18 years or older
- EPDS score >10
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
Read the detailed description
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).
Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.
A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.
- Conditions
- Postpartum Depression
- Being tested
- Cognitive Behavioural Therapy
- Keywords
- Cognitive Therapy, Workshop, Postpartum Depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
The intervention is a 1-day Cognitive Behavioural Therapy based workshop.
| Study group | Role | What they receive |
|---|---|---|
| 1-Day CBT Workshop - Immediate | Experimental | Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart). Receives: Behavioral: Cognitive Behavioural Therapy |
| 1-Day CBT Workshop - Waitlist | Experimental | Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart). Receives: Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (EPDS)
EPDS is the 10-item gold standard measure of PPD. A score >10 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change
Measured: 3 months
Beck Depression Inventory-II
The Beck Depression Inventory is a 21-item scale that assesses the emotional and cognitive symptoms of depression as the EPDS does, but additionally captures the somatic symptoms of depression. Higher scores on the BDI-II indicate more sever depression. The minimum score is 0 and maximum score is 63. Items are summed to generate a total score. 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.
Measured: 3 months
Secondary outcomes (8)
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a 7-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. The minimum score is 0 and the maximum score is 21. Items are summed to generate a total score. Scores of 5-9 indicate mild anxiety, 10-14 indicate moderate anxiety and 15 or greater indicate severe anxiety.
Measured: 3 months
Postpartum Bonding Questionnaire
Postpartum Bonding Questionnaire is a 25-item maternal report scale that is designed to detect disorders of the mother-infant relationship. Scores range on each question from 0 (Always) to 5 (Never) and are summed to generate subscale scores. The subscales include: impaired bonding, rejection and pathological anger, infant focused anxiety and incipient abuse. Higher scores indicate problems with bonding.
Measured: 3 months
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item patient reported scale that is designed to measure client satisfaction with services. The Maximum score is 32 and the minimum score is 4. Higher scores indicate greater satisfaction.
Measured: Immediately after workshop
Healthcare Utilization
As depression is associated with increased rates of healthcare use, mothers will answer the Health Care Utilization questions of the Canadian Community Health Survey at all time points. Mothers will also answer the General Help-Seeking Questionnaire and the Mental Help Seeking Intention Scale at all time points, in order to measure the likelihood that they will seek help from healthcare professionals.
Measured: 3 months
Infant Behaviour Questionnaire-Revised (Very short form)
To assess infant temperament if infants. The measure takes a mean value of the questions to which a response was provided.
Measured: 3 months
Strengths and Difficulties Questionnaire
To assess temperament of 2-4 year olds. Each response has values of 0, 1 and 2. These are summed to generate a total score for each subscale: Emotional Problems Scale, Conduct Problems Scale, Hyperactivity Scale, Peer Problems Scale, Prosocial Scale. The minimum score for each scale is 0 and the maximum is 10. Higher scores indicate greater difficulties.
Measured: 3 months
Early Childhood Behaviour Questionnaire (very short form)
To assess temperament of children 18-36 months. The subscales include negative affect, surgency and effortful control. The measure takes a mean value of the questions to which a response was provided.
Measured: 3 months
EQ-5D
The EQ-5D, a measure of health-related quality of life will also be completed by mothers. Health status is measured on five dimensions on three-point scales. The associated tariffs for Canada are then applied to calculate quality-adjusted life-years (QALYs). The instrument also includes a visual analogue scale, allowing individuals to rate their current health status on a scale from 0 (worst) to 100 (best).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jan 2018
- Primary completion17 Aug 2020
- Study completion1 Oct 2020
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
- Masking
- None (open label)
- Enrolment
- 461 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
- NCT03654261
- Sponsor's protocol ID
- 1Day-CBT
- Status last verified
- May 2022
- First submitted
- 29 Aug 2018
- Last updated
- 25 May 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 42383885Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.
PubMed 34232578
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression
- ClinicalTrials.gov ID
- NCT03654261
- Acronym / sponsor ID
- 1Day-CBT
- Conditions
- Postpartum Depression
- Keywords
- Cognitive Therapy, Workshop, Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 31 Aug 2018 (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.
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
Detailed description
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).
Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.
A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Day CBT Workshop - Immediate | Experimental | Behavioral: Cognitive Behavioural TherapyWomen assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart). |
| 1-Day CBT Workshop - Waitlist | Experimental | Behavioral: Cognitive Behavioural TherapyWomen assigned to the waitlist will participate in the second of two workshops (12 weeks apart). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- infant <12 months
- 18 years or older
- EPDS score >10
Key exclusion criteria (1 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 |
|---|---|---|
| Cognitive Behavioural TherapyThe intervention is a 1-day Cognitive Behavioural Therapy based workshop. | Behavioural | 1-Day CBT Workshop - Immediate, 1-Day CBT Workshop - Waitlist |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 3 months
EPDS is the 10-item gold standard measure of PPD. A score >10 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change
Beck Depression Inventory-II
Time frame: 3 months
The Beck Depression Inventory is a 21-item scale that assesses the emotional and cognitive symptoms of depression as the EPDS does, but additionally captures the somatic symptoms of depression. Higher scores on the BDI-II indicate more sever depression. The minimum score is 0 and maximum score is 63. Items are summed to generate a total score. 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.
8 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 3 months
Postpartum Bonding Questionnaire
Time frame: 3 months
Client Satisfaction Questionnaire
Time frame: Immediately after workshop
Healthcare Utilization
Time frame: 3 months
Infant Behaviour Questionnaire-Revised (Very short form)
Time frame: 3 months
Strengths and Difficulties Questionnaire
Time frame: 3 months
Early Childhood Behaviour Questionnaire (very short form)
Time frame: 3 months
EQ-5D
Time frame: 3 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 May 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 34232578Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.
- 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 Cognitive Behavioural Therapy 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 3 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 May 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?
Edinburgh Postnatal Depression Scale (EPDS) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03654261, 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 May 2022.