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NCT Number: NCT07758036

Group CBT for Paternal Perinatal Depression RCT

The purpose of the proposed study is to determine the effectiveness of an online, 9-week group CBT intervention for paternal perinatal depression 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Paternal Perinatal Depression

Behavioral

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.

Primary outcomes

  1. Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 9 weeks

    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.

Secondary outcomes

  1. 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.

  2. Major Depressive Disorder

    Time frame: 9 weeks

    We will compare DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.

  3. Major Depressive Disorder

    Time frame: 6 months post enrollment

    We will compare DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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. We will use its Canadian algorithm 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).

  19. 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. We will use its Canadian algorithm 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).

Other outcomes

  1. Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 9 weeks (immediately post treatment in intervention group)

    Intervention participants only. We will assess participant satisfaction with the intervention 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan J Van Lieshout, MD, PhD

CONTACT

[email protected]

(905) 522-1155 ext. 35123

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Ottawa Public Health

Registry information

Official study title

Group Cognitive Behavioural Therapy for Paternal Perinatal Depression: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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