Group CBT for Paternal Perinatal Depression
11 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
112
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ryan J Van Lieshout, MD, PhD
- Número de teléfono: 35123 (905) 522-1155
- Correo electrónico: vanlierj@mcmaster.ca
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8S4L8
- McMaster University
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Contacto:
- Ryan J Van Lieshout, MD, PhD
- Número de teléfono: 35123 (905) 522-1155
- Correo electrónico: vanlierj@mcmaster.ca
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control/cuidado habitual
Los participantes aleatorizados al grupo de no intervención continuarán recibiendo tratamiento como de costumbre (atención estándar).
Se enviará una lista de recursos por correo electrónico.
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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.
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La terapia cognitiva conductual (TCC) es un tipo de psicoterapia (terapia de conversación).
Las sesiones grupales semanales durarán dos horas y tendrán lugar una vez por semana durante 9 semanas consecutivas.
La primera hora de la sesión implicará la enseñanza y la práctica de las habilidades de TCC, seguida de una hora de discusión no estructurada sobre temas relevantes para los participantes con depresión perinatal paterna.
Cada grupo se entregará en línea a través de Zoom y guiado por nuestro manual de intervención.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Periodo de tiempo: 6 months post enrollment
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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.
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6 months post enrollment
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Anxiety Symptoms - GAD-7
Periodo de tiempo: 9 weeks
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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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9 weeks
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Anxiety Symptoms - GAD-7
Periodo de tiempo: 6 months post enrollment
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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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6 months post enrollment
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Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Parenting Stress - Parenting Stress Index Short Form (PSI-SF)
Periodo de tiempo: 6 months post enrollment
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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.
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6 months post enrollment
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Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
Periodo de tiempo: 6 months post enrollment
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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.
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6 months post enrollment
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Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
Periodo de tiempo: 6 months post enrollment
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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.
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6 months post enrollment
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Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Infant Temperament - Infant Behaviour Questionnaire Revised Very Short Form (IBQ-R)
Periodo de tiempo: 6 months post enrollment
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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.
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6 months post enrollment
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Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 6 months post enrollment
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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.
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6 months post enrollment
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Cost-effectiveness - Healthcare Resource Utilization
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Cost-effectiveness - Healthcare Resource Utilization
Periodo de tiempo: 6 months post enrollment
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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.
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6 months post enrollment
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Major Depressive Disorder
Periodo de tiempo: 9 weeks
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DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
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9 weeks
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Major Depressive Disorder
Periodo de tiempo: 6 months post enrollment
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DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
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6 months post enrollment
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Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
Periodo de tiempo: 9 weeks
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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).
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9 weeks
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Cost-effectiveness analysis - Quality Adjusted Life Year (QALY)
Periodo de tiempo: 6 months post enrollment
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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).
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6 months post enrollment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
Periodo de tiempo: 9 weeks (immediately post treatment in intervention group)
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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.
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9 weeks (immediately post treatment in intervention group)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
6 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de agosto de 2026
Publicado por primera vez (Actual)
11 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20403
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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