Group CBT for Paternal Perinatal Depression
11 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
112
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ryan J Van Lieshout, MD, PhD
- Número de telefone: 35123 (905) 522-1155
- E-mail: vanlierj@mcmaster.ca
Locais de estudo
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Ontario
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Hamilton, Ontario, Canadá, L8S4L8
- McMaster University
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Contato:
- Ryan J Van Lieshout, MD, PhD
- Número de telefone: 35123 (905) 522-1155
- E-mail: vanlierj@mcmaster.ca
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Controle/cuidados usuais
Os participantes randomizados para o Grupo de Intervenção Não continuarão recebendo tratamento como de costume (atendimento padrão).
Uma lista de recursos será enviada por e -mail.
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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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A terapia cognitivo -comportamental (TCC) é um tipo de psicoterapia (terapia de conversação).
As sessões semanais de grupo terão duas horas de duração e ocorrerão uma vez por semana durante 9 semanas consecutivas.
A primeira hora da sessão envolverá o ensino e a prática das habilidades da TCC, seguidas de uma hora de discussão não estruturada sobre tópicos relevantes para os participantes com depressão perinatal paterna.
Cada grupo será entregue on -line via zoom e guiado pelo nosso manual de intervenção.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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).
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6 months post enrollment
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de setembro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2029
Conclusão do estudo (Estimado)
31 de dezembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
6 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de agosto de 2026
Primeira postagem (Real)
11 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20403
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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