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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
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.
McMaster University
Hamilton, Ontario, Canada
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.
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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