An interventional study of Cognitive Behavioral Therapy for Paternal Perinatal Depression in Perinatal Depression and Fathers, sponsored by McMaster University. Not yet recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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Among 14 studies in Depression by McMaster University — 1 open to participants now, 2 under way, none of them phase 3. Depression · McMaster University.
Among the 14 studies in Depression by McMaster University, this one is the only one that started in 2026, is one of 9 with no phase, and was the 14th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →1 of the 14 studies in Depression by McMaster University is open now, in 1 country.
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 112 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 80 across the 9 interventional studies, 200 across the 5 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
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McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Depression by McMaster University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The experimental group will receive a 9-week group CBT intervention in addition to receiving treatment as usual.
Behavioral: Cognitive Behavioral Therapy for Paternal Perinatal Depression
Participants randomized to the No Intervention group will continue to receive treatment as usual (standard care). A list of resources will be emailed.
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.
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.
Time frame: 9 weeks
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.
Time frame: 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.
Time frame: 9 weeks
Major Depressive Disorder
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 6 months post enrollment
Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
Intervention participants only. Satisfaction with the intervention will be assessed using the eight-item Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of eight items assessing the level of satisfaction with the intervention on a 4-point Likert-type scale, as well as one open-ended question. Responses to the open-ended question will be analyzed using content analysis to inform acceptability of the intervention.
Time frame: 9 weeks (immediately post treatment in intervention group)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 39 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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