Postpartum Depression (PPD)NCT07162129
Online Transdiagnostic Group CBT for Postpartum Depression and Anxiety
A study testing Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety in people with Postpartum Depression (PPD) and Postpartum Anxiety, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this pilot study is to test the feasibility of an online 10-Week group cognitive behavioural therapy (CBT; a type of talking therapy) intervention for postpartum depression and anxiety that is led by psychotherapists, social workers, a psychologist and/or a psychiatrist. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression (PPD), Postpartum Anxiety
- What is being tested?
- Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years old
- have an infant <12 months at recruitment
- fluent in written/spoken English
- have an EPDS score ≥10 and/or a GAD-7 score≥10
- live in Ontario, Canada
Who cannot join
- does not meet diagnostic criteria for bipolar, psychotic, borderline personality and current substance use disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Transdiagnostic Group Cognitive Behavioural Therapy (CBT) for Postpartum Depression and Anxiety: A Pilot Randomized Controlled Trial
The purpose of this pilot study is to test the feasibility of an online 10-Week group cognitive behavioural therapy (CBT; a type of talking therapy) intervention for postpartum depression and anxiety that is led by psychotherapists, social workers, a psychologist and/or a psychiatrist. Mothers and birthing parents who are 18 years or older, have an infant under 12 months, living in Ontario and who have postpartum depression and/or anxiety symptoms will be assigned with a 50/50 chance (like flipping a coin) to receive online transdiagnostic group CBT in addition to usual postnatal care, or to receive usual postnatal care only.
Read the detailed description
This study will involve a pilot randomized controlled trial (RCT) to determine the feasibility of a 10-week group CBT intervention for treating postpartum depression and anxiety and study procedures. Primary feasibility objectives include recruitment, completion of study measures, retention and participant satisfaction/acceptability of the intervention. The secondary objective of the pilot RCT is to estimate the treatment effects on PPD and anxiety symptoms to guide the conduct of a future full-scale RCT of the intervention.
48 Participants will be assigned in a 1:1 ratio to the experimental (transdiagnostic CBT group plus treatment as usual (TAU)) or control group (TAU alone). Participants in both groups will complete all study questionnaires at baseline (T1), 10 weeks later (T2 - immediately post-intervention in the experimental group to assess effectiveness), and 6 months after enrollment (T3 - intervention durability). Participants in the treatment group will complete a satisfaction questionnaire with three open-ended questions that will explore their experiences and recommendations for improving the intervention.
- Conditions
- Postpartum Depression (PPD), Postpartum Anxiety
- Being tested
- Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety
- Keywords
- Transdiagnostic, Postpartum Depression, Postpartum Anxiety, Cognitive Behavioural Therapy
- 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 Behavioral Therapy for Postpartum Depression (PPD) and AnxietyBehavioural
Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). Each session will be two hours in duration. The 1st hour involves teaching and practice of CBT skills followed by one hour of unstructured discussion about topics relevant to PPD and PPA (sleep, supports, transitions). Each group will be delivered online via Zoom and guided by our intervention manual.
| Study group | Role | What they receive |
|---|---|---|
| 10-week Transdiagnostic Group CBT Intervention | Experimental | The experimental group will receive a 10-week transdiagnostic group CBT intervention delivered by a pair of trained mental health providers (psychiatrists, psychologists, social workers, nurses and/or registered psychotherapists) in addition to receiving treatment as usual. Receives: Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety |
| Control - usual care | No intervention | Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited in recruitment period
Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months
Measured: 6 months
Number of participants who complete all data collection procedures
75% of participants complete all three questionnaires and structured interviews
Measured: 6 months
Number of participants who complete study (retention)
75% of participants remain in study until completion
Measured: 6 months
Number of participants who complete the intervention (adherence)
80% of participants in treatment group complete the intervention
Measured: 6 months
Secondary outcomes (2)
Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)
Postpartum depression (PPD) is best conceptualized as a continuous construct with its impact operating across a continuum of severity, and so a continuous measure of PPD (EPDS) is our primary outcome. In keeping with most PPD RCTs, our primary effectiveness timepoint is immediately post-treatment (T2). The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PPD, ≥13 is consistent with probable PPD and changes in scores >4 are accepted as being indicative of clinically significant change.
Measured: 10 weeks
Estimate Treatment effect - GAD-7
A reliable and valid 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PPD. A cutoff of ≥10 defines clinically important levels of anxiety symptoms and changes in scores >4 are accepted as being indicative of clinically significant change.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start9 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies 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
- Model description
- A parallel-group Ontario-wide RCT with experimental (CBT group) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Van Lieshout, MD, PhD, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162129
- Sponsor's protocol ID
- Group CBT for PPD & PPA Pilot
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Transdiagnostic Group Cognitive Behavioural Therapy (CBT) for Postpartum Depression and Anxiety: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07162129
- Acronym / sponsor ID
- Group CBT for PPD & PPA Pilot
- Conditions
- Postpartum Depression (PPD), Postpartum Anxiety
- Keywords
- Transdiagnostic, Postpartum Depression, Postpartum Anxiety, Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Sep 2025 (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 purpose of this pilot study is to test the feasibility of an online 10-Week group cognitive behavioural therapy (CBT; a type of talking therapy) intervention for postpartum depression and anxiety that is led by psychotherapists, social workers, a psychologist and/or a psychiatrist. Mothers and birthing parents who are 18 years or older, have an infant under 12 months, living in Ontario and who have postpartum depression and/or anxiety symptoms will be assigned with a 50/50 chance (like flipping a coin) to receive online transdiagnostic group CBT in addition to usual postnatal care, or to receive usual postnatal care only.
Detailed description
This study will involve a pilot randomized controlled trial (RCT) to determine the feasibility of a 10-week group CBT intervention for treating postpartum depression and anxiety and study procedures. Primary feasibility objectives include recruitment, completion of study measures, retention and participant satisfaction/acceptability of the intervention. The secondary objective of the pilot RCT is to estimate the treatment effects on PPD and anxiety symptoms to guide the conduct of a future full-scale RCT of the intervention.
48 Participants will be assigned in a 1:1 ratio to the experimental (transdiagnostic CBT group plus treatment as usual (TAU)) or control group (TAU alone). Participants in both groups will complete all study questionnaires at baseline (T1), 10 weeks later (T2 - immediately post-intervention in the experimental group to assess effectiveness), and 6 months after enrollment (T3 - intervention durability). Participants in the treatment group will complete a satisfaction questionnaire with three open-ended questions that will explore their experiences and recommendations for improving the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group Ontario-wide RCT with experimental (CBT group) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.
| Arm | Type | Receives |
|---|---|---|
| 10-week Transdiagnostic Group CBT Intervention | Experimental | Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD) and AnxietyThe experimental group will receive a 10-week transdiagnostic group CBT intervention delivered by a pair of trained mental health providers (psychiatrists, psychologists, social workers, nurses and/or registered psychotherapists) in addition to receiving treatment as usual. |
| Control - usual care | No intervention | –Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- have an infant <12 months at recruitment
- fluent in written/spoken English
- have an EPDS score ≥10 and/or a GAD-7 score≥10
- live in Ontario, Canada
Key exclusion criteria (1 listed)
- does not meet diagnostic criteria for bipolar, psychotic, borderline personality and current substance use disorders
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 Behavioral Therapy for Postpartum Depression (PPD) and AnxietyCognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). Each session will be two hours in duration. The 1st hour involves teaching and practice of CBT skills followed by one hour of unstructured discussion about topics relevant to PPD and PPA (sleep, supports, transitions). Each group will be delivered online via Zoom and guided by our intervention manual. | Behavioural | 10-week Transdiagnostic Group CBT Intervention |
Primary outcome
Number of participants recruited in recruitment period
Time frame: 6 months
Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months
Number of participants who complete all data collection procedures
Time frame: 6 months
75% of participants complete all three questionnaires and structured interviews
Number of participants who complete study (retention)
Time frame: 6 months
75% of participants remain in study until completion
Number of participants who complete the intervention (adherence)
Time frame: 6 months
80% of participants in treatment group complete the intervention
2 secondary outcomes
Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 10 weeks
Estimate Treatment effect - GAD-7
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression (PPD)
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Behavioral Therapy for Postpartum Depression (PPD) and Anxiety in people with Postpartum Depression (PPD) and Postpartum Anxiety, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants recruited in recruitment period (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.