Group CBT for Paternal Perinatal Depression
11 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
112
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ryan J Van Lieshout, MD, PhD
- Telefoonnummer: 35123 (905) 522-1155
- E-mail: vanlierj@mcmaster.ca
Studie Locaties
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Ontario
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Hamilton, Ontario, Canada, L8S4L8
- McMaster University
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Contact:
- Ryan J Van Lieshout, MD, PhD
- Telefoonnummer: 35123 (905) 522-1155
- E-mail: vanlierj@mcmaster.ca
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Controle/gebruikelijke zorg
Deelnemers gerandomiseerd naar de NO -interventiegroep zullen zoals gewoonlijk worden behandeld (standaardzorg).
Een lijst met bronnen wordt gemaild.
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Experimenteel: 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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Cognitieve gedragstherapie (CBT) is een soort psychotherapie (talk -therapie).
De wekelijkse groepssessies zullen twee uur lang duren en vinden eenmaal per week gedurende 9 opeenvolgende weken plaats.
Het eerste uur van de sessie omvat het onderwijzen en beoefenen van CBT -vaardigheden, gevolgd door een uur ongestructureerde discussie over onderwerpen die relevant zijn voor deelnemers met perinatale depressie van vaderszijde.
Elke groep wordt online geleverd via Zoom en geleid door onze interventiehandleiding.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
15 september 2026
Primaire voltooiing (Geschat)
31 december 2029
Studie voltooiing (Geschat)
31 december 2029
Studieregistratiedata
Eerst ingediend
6 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
6 augustus 2026
Eerst geplaatst (Werkelijk)
11 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
11 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20403
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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