Group CBT for Paternal Perinatal Depression

August 11, 2026 updated by: Ryan Van Lieshout, MD, PhD, McMaster University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S4L8
        • McMaster University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Free of bipolar, psychotic, borderline personality and current substance use disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control/Usual Care
Participants randomized to the No Intervention group will continue to receive treatment as usual (standard care). A list of resources will be emailed.
Experimental: 9-Week Group Cognitive Behavioural Therapy Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Anxiety Symptoms - GAD-7
Time Frame: 9 weeks
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.
9 weeks
Anxiety Symptoms - GAD-7
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
Time Frame: 9 weeks
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.
9 weeks
Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
Time Frame: 9 weeks
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.
9 weeks
Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
Time Frame: 9 weeks
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.
9 weeks
Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
Time Frame: 9 weeks
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.
9 weeks
Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 9 weeks
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.
9 weeks
Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Cost-effectiveness - Healthcare Resource Utilization
Time Frame: 9 weeks
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.
9 weeks
Cost-effectiveness - Healthcare Resource Utilization
Time Frame: 6 months post enrollment
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.
6 months post enrollment
Major Depressive Disorder
Time Frame: 9 weeks
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
9 weeks
Major Depressive Disorder
Time Frame: 6 months post enrollment
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
6 months post enrollment
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
Time Frame: 9 weeks
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).
9 weeks
Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
Time Frame: 6 months post enrollment
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).
6 months post enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 9 weeks (immediately post treatment in intervention group)
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.
9 weeks (immediately post treatment in intervention group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ottawa Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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