Perinatal DepressionNCT07758036
Group CBT for Paternal Perinatal Depression
A study testing Cognitive Behavioral Therapy for Paternal Perinatal Depression in people with Perinatal Depression and Fathers, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of the proposed study is to determine the effectiveness of an online, 9-week group cognitive behavioural therapy (CBT) intervention for paternal perinatal depression (PND) in fathers and fathers-to-be. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Perinatal Depression, Fathers
- What is being tested?
- Cognitive Behavioral Therapy for Paternal Perinatal Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2026to 31 Dec 2029
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers who have an infant <18 months at recruitment
- Fluent in written/spoken English
- Have an EPDS score ≥9
- Live in Ontario
Who cannot join
- Free of bipolar, psychotic, borderline personality and current substance use disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McMaster University
Hamilton, Ontario, L8S4L8
Ryan J Van Lieshout, MD, PhD, (905) 522-1155 ext. 35123, vanlierj@mcmaster.ca
About this study
Official title: Group Cognitive Behavioural Therapy for Paternal Perinatal Depression: A Randomized Controlled Trial
The purpose of the proposed study is to determine the effectiveness of an online, 9-week group cognitive behavioural therapy (CBT) intervention for paternal perinatal depression (PND) in fathers and fathers-to-be. Fathers or fathers-to-be living in Ontario, Canada who have depression symptoms while their partner has been pregnant and/or during the first 18 months of their child's life will be assigned with a 50/50 chance (like flipping a coin) to receive online group CBT in addition to usual care, or to receive usual care only.
Read the detailed description
This study will involve a randomized controlled trial (RCT) to determine the effectiveness of a 9-week group CBT intervention added to treatment as usual (TAU) compared to TAU alone for improving paternal perinatal depression symptoms. The primary objective is to determine the effectiveness of the intervention for treating paternal perinatal depression symptoms, and secondary objectives will assess whether the intervention leads to improvements in common comorbidities (anxiety) and complications (parenting stress, social isolation, partner relationship quality, parent-infant attachment, and offspring behaviour) and whether it is cost-effective.
112 participants will be assigned in a 1:1 ratio to the experimental or control group. Participants in both groups will complete online questionnaires and structured telephone interviews at baseline (T1), 9 weeks later (T2 - immediately post-intervention in the experimental group) and 6 months post-enrollment (T3). Those assigned to receive the 9-week CBT group will also be asked questions about their satisfaction with the program and recommendations for improvement.
- Conditions
- Perinatal Depression, Fathers
- Being tested
- Cognitive Behavioral Therapy for Paternal Perinatal Depression
- Keywords
- cognitive behavioral therapy, paternal depression, perinatal depression, fathers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Paternal Perinatal DepressionBehavioural
Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The weekly group sessions will be two hours long and take place once a week for 9 consecutive weeks. The first hour of the session will involve teaching and practice of CBT skills, followed by one hour of unstructured discussion around topics relevant to participants with paternal perinatal depression. Each group will be delivered online via Zoom and guided by our intervention manual.
| Study group | Role | What they receive |
|---|---|---|
| 9-Week Group Cognitive Behavioural Therapy Intervention | Experimental | The experimental group will receive a 9-week group CBT intervention in addition to receiving treatment as usual. Receives: Behavioral: Cognitive Behavioral Therapy for Paternal Perinatal Depression |
| Control/Usual Care | No intervention | Participants randomized to the No Intervention group will continue to receive treatment as usual (standard 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.
Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of perinatal depression (PND). Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores >4 are accepted as being indicative of clinically significant change.
Measured: 9 weeks
Secondary outcomes (19)
Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PND. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores >4 are accepted as being indicative of clinically significant change.
Measured: 6 months post enrollment
Major Depressive Disorder
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
Measured: 9 weeks
Major Depressive Disorder
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
Measured: 6 months post enrollment
Anxiety Symptoms - GAD-7
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) will be used to assess anxiety symptoms. The GAD-7 is a 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PND. Items are scored on a 0-3 point scale with total scores ranging from 0-21. Higher scores indicate more severe anxiety symptoms.
Measured: 9 weeks
Anxiety Symptoms - GAD-7
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) will be used to assess anxiety symptoms. The GAD-7 is a 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PND. Items are scored on a 0-3 point scale with total scores ranging from 0-21. Higher scores indicate more severe anxiety symptoms.
Measured: 6 months post enrollment
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
A 36-item self-report measure of parenting stress. Items are scored on a 1-5 point scale with total scores ranging from 36-180. Higher scores indicate greater parenting stress.
Measured: 9 weeks
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
A 36-item self-report measure of parenting stress. Items are scored on a 1-5 point scale with total scores ranging from 36-180. Higher scores indicate greater parenting stress.
Measured: 6 months post enrollment
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
A 32-item self-report measure assessing partner relationship quality. Items are rated on a 5-, 6-, or 7-point scale or yes/no response. Total scores range from 0-151, with higher scores indicating better relationship adjustment and quality.
Measured: 9 weeks
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
A 32-item self-report measure assessing partner relationship quality. Items are rated on a 5-, 6-, or 7-point scale or yes/no response. Total scores range from 0-151, with higher scores indicating better relationship adjustment and quality.
Measured: 6 months post enrollment
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
A 25-item self-report measure; each item is scored on a 0-5-point scale. Total scores range from 0-125 with higher scores indicating greater impairment in bonding. Subscales include: Impaired Boding, Rejection and Anger, Infant-Focused Anxiety, Risk of Abuse.
Measured: 9 weeks
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
A 25-item self-report measure; each item is scored on a 0-5-point scale. Total scores range from 0-125 with higher scores indicating greater impairment in bonding. Subscales include: Impaired Boding, Rejection and Anger, Infant-Focused Anxiety, Risk of Abuse.
Measured: 6 months post enrollment
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
A 37 self-report measure. Each item is scored on a 7-point likert scale, with 'does not apply' option available. Mean scores of items responded to are generated for each subscale. Higher scores indicate higher levels of the measured temperament trait. Subscales assessed include Positive Affectivity/Surgency, Negative Emotionality, Orienting/Regulatory Capacity.
Measured: 9 weeks
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
A 37 self-report measure. Each item is scored on a 7-point likert scale, with 'does not apply' option available. Mean scores of items responded to are generated for each subscale. Higher scores indicate higher levels of the measured temperament trait. Subscales assessed include Positive Affectivity/Surgency, Negative Emotionality, Orienting/Regulatory Capacity.
Measured: 6 months post enrollment
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure assessing depression symptoms. Each item is scored on a 0-3-point scale with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms.
Measured: 9 weeks
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure assessing depression symptoms. Each item is scored on a 0-3-point scale with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms.
Measured: 6 months post enrollment
Cost-effectiveness - Healthcare Resource Utilization
To inform cost-effectiveness analysis, healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period (based on the Canadian Community Health Survey and Service Use and Resources Form). Participants will provide information on all healthcare service and medication use over the trial period.
Measured: 9 weeks
Cost-effectiveness - Healthcare Resource Utilization
To inform cost-effectiveness analysis, healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period (based on the Canadian Community Health Survey and Service Use and Resources Form). Participants will provide information on all healthcare service and medication use over the trial period.
Measured: 6 months post enrollment
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
To inform cost-effectiveness analysis, the EQ-5D-5L will be collected. This is a utility-based health-related quality of life instrument assessing five domains (mobility, self-care, usual activities, pain, depression/anxiety) and will be administered at T1-T3. The Canadian algorithm will be used to convert responses to health utility. QALYs will be calculated by multiplying the health utility for the corresponding time period (i.e., area under the curve approach).
Measured: 9 weeks
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
To inform cost-effectiveness analysis, the EQ-5D-5L will be collected. This is a utility-based health-related quality of life instrument assessing five domains (mobility, self-care, usual activities, pain, depression/anxiety) and will be administered at T1-T3. The Canadian algorithm will be used to convert responses to health utility. QALYs will be calculated by multiplying the health utility for the corresponding time period (i.e., area under the curve approach).
Measured: 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal 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
- A parallel-group Ontario-wide RCT with experimental (9-week CBT + TAU) and control (TAU) 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Public Health
- Responsible party
- Principal investigator, Ryan Van Lieshout, MD, PhD, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758036
- Sponsor's protocol ID
- 20403
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Cognitive Behavioural Therapy for Paternal Perinatal Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07758036
- Acronym / sponsor ID
- 20403
- Conditions
- Perinatal Depression, Fathers
- Keywords
- cognitive behavioral therapy, paternal depression, perinatal depression, fathers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Ottawa Public Health
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Aug 2026 (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 the proposed study is to determine the effectiveness of an online, 9-week group cognitive behavioural therapy (CBT) intervention for paternal perinatal depression (PND) in fathers and fathers-to-be. Fathers or fathers-to-be living in Ontario, Canada who have depression symptoms while their partner has been pregnant and/or during the first 18 months of their child's life will be assigned with a 50/50 chance (like flipping a coin) to receive online group CBT in addition to usual care, or to receive usual care only.
Detailed description
This study will involve a randomized controlled trial (RCT) to determine the effectiveness of a 9-week group CBT intervention added to treatment as usual (TAU) compared to TAU alone for improving paternal perinatal depression symptoms. The primary objective is to determine the effectiveness of the intervention for treating paternal perinatal depression symptoms, and secondary objectives will assess whether the intervention leads to improvements in common comorbidities (anxiety) and complications (parenting stress, social isolation, partner relationship quality, parent-infant attachment, and offspring behaviour) and whether it is cost-effective.
112 participants will be assigned in a 1:1 ratio to the experimental or control group. Participants in both groups will complete online questionnaires and structured telephone interviews at baseline (T1), 9 weeks later (T2 - immediately post-intervention in the experimental group) and 6 months post-enrollment (T3). Those assigned to receive the 9-week CBT group will also be asked questions about their satisfaction with the program and recommendations for improvement.
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 (9-week CBT + TAU) and control (TAU) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.
| Arm | Type | Receives |
|---|---|---|
| 9-Week Group Cognitive Behavioural Therapy Intervention | Experimental | Behavioral: Cognitive Behavioral Therapy for Paternal Perinatal DepressionThe experimental group will receive a 9-week group CBT intervention 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 care). A list of resources will be emailed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers who have an infant <18 months at recruitment
- Fluent in written/spoken English
- Have an EPDS score ≥9
- Live in Ontario
Key exclusion criteria (1 listed)
- Free of 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 Paternal Perinatal DepressionCognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The weekly group sessions will be two hours long and take place once a week for 9 consecutive weeks. The first hour of the session will involve teaching and practice of CBT skills, followed by one hour of unstructured discussion around topics relevant to participants with paternal perinatal depression. Each group will be delivered online via Zoom and guided by our intervention manual. | Behavioural | 9-Week Group Cognitive Behavioural Therapy Intervention |
Primary outcome
Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 9 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of perinatal depression (PND). Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PND, ≥13 is consistent with probable PND and changes in scores >4 are accepted as being indicative of clinically significant change.
19 secondary outcomes
Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 6 months post enrollment
Major Depressive Disorder
Time frame: 9 weeks
Major Depressive Disorder
Time frame: 6 months post enrollment
Anxiety Symptoms - GAD-7
Time frame: 9 weeks
Anxiety Symptoms - GAD-7
Time frame: 6 months post enrollment
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
Time frame: 9 weeks
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
Time frame: 6 months post enrollment
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
Time frame: 9 weeks
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
Time frame: 6 months post enrollment
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
Time frame: 9 weeks
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
Time frame: 6 months post enrollment
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
Time frame: 9 weeks
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
Time frame: 6 months post enrollment
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Time frame: 9 weeks
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6 months post enrollment
Cost-effectiveness - Healthcare Resource Utilization
Time frame: 9 weeks
Cost-effectiveness - Healthcare Resource Utilization
Time frame: 6 months post enrollment
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
Time frame: 9 weeks
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
Time frame: 6 months post enrollment
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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Fathers and Babies (FAB) Research Study
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Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
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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.
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 Paternal Perinatal Depression in people with Perinatal Depression and Fathers, 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 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: opening soon, as of the sponsor's last update on 13 Aug 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?
Contact Ryan J Van Lieshout, MD, PhD ((905) 522-1155 ext. 35123, vanlierj@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS) (time frame: 9 weeks). 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 13 Aug 2026.