Group CBT for Paternal Perinatal Depression
11. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
112
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ryan J Van Lieshout, MD, PhD
- Telefonnummer: 35123 (905) 522-1155
- E-post: vanlierj@mcmaster.ca
Studiesteder
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Ontario
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Hamilton, Ontario, Canada, L8S4L8
- McMaster University
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Ta kontakt med:
- Ryan J Van Lieshout, MD, PhD
- Telefonnummer: 35123 (905) 522-1155
- E-post: vanlierj@mcmaster.ca
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Kontroll/vanlig pleie
Deltakerne som er randomisert til ingen intervensjonsgruppe vil fortsette å motta behandling som vanlig (standardpleie).
En liste over ressurser vil bli sendt e -post.
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Eksperimentell: 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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Kognitiv atferdsterapi (CBT) er en type psykoterapi (talkterapi).
De ukentlige gruppeøktene vil være to timer lange og finne sted en gang i uken i 9 uker på rad.
Den første timen av økten vil innebære undervisning og utøvelse av CBT -ferdigheter, etterfulgt av en times ustrukturert diskusjon rundt temaer som er relevante for deltakere med faderlig perinatal depresjon.
Hver gruppe vil bli levert online via zoom og veiledet av vår intervensjonshåndbok.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
15. september 2026
Primær fullføring (Antatt)
31. desember 2029
Studiet fullført (Antatt)
31. desember 2029
Datoer for studieregistrering
Først innsendt
6. august 2026
Først innsendt som oppfylte QC-kriteriene
6. august 2026
Først lagt ut (Faktiske)
11. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20403
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