Group CBT for Paternal Perinatal Depression
11. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
112
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ryan J Van Lieshout, MD, PhD
- Telefonní číslo: 35123 (905) 522-1155
- E-mail: vanlierj@mcmaster.ca
Studijní místa
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Ontario
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Hamilton, Ontario, Kanada, L8S4L8
- McMaster University
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Kontakt:
- Ryan J Van Lieshout, MD, PhD
- Telefonní číslo: 35123 (905) 522-1155
- E-mail: vanlierj@mcmaster.ca
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Kontrola/obvyklá péče
Účastníci randomizovaní do intervenční skupiny NO budou i nadále léčba jako obvykle (standardní péče).
Seznam zdrojů bude zaslán e -mailem.
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Experimentální: 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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Kognitivní behaviorální terapie (CBT) je typ psychoterapie (terapie Talk).
Týdenní skupinové sezení budou trvat dvě hodiny a bude se konat jednou týdně po dobu 9 po sobě jdoucích týdnů.
První hodina zasedání bude zahrnovat výuku a praxi dovedností CBT, po kterém následuje jedna hodina nestrukturované diskuse o tématech týkajících se účastníků s otcovskou perinatální depresí.
Každá skupina bude doručena online prostřednictvím Zoom a vedena naší intervenční příručkou.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.
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6 months post enrollment
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Partner Relationship Quality - Dyadic Adjustment Scale (DAS)
Časové okno: 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)
Časové okno: 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.
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6 months post enrollment
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Parent-Infant Bonding - Postpartum Bonding Questionnaire (PBQ)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.
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6 months post enrollment
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Depression Symptoms - Patient Health Questionnaire-9 (PHQ-9)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
15. září 2026
Primární dokončení (Odhadovaný)
31. prosince 2029
Dokončení studie (Odhadovaný)
31. prosince 2029
Termíny zápisu do studia
První předloženo
6. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
6. srpna 2026
První zveřejněno (Aktuální)
11. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
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