Group CBT for Paternal Perinatal Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorMcMaster University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Free of bipolar, psychotic, borderline personality and current substance use disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Paternal Perinatal Depression
BehavioralCognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The weekly group sessions will be two hours long and take place once a week for 9 consecutive weeks. The first hour of the session will involve teaching and practice of CBT skills, followed by one hour of unstructured discussion around topics relevant to participants with paternal perinatal depression. Each group will be delivered online via Zoom and guided by our intervention manual.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: 9-Week Group Cognitive Behavioural Therapy InterventionExperimental treatment 1 intervention
Group B: Control/Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Paternal Perinatal Depression (PND) Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
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.
Time frame
9 weeksSecondary outcomes
1
Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS)
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.
Time frame
6 months post enrollment2
Major Depressive Disorder
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
Time frame
9 weeks3
Major Depressive Disorder
DSM-5-defined current major depressive disorder (MDD) using the Diagnostic Assessment Research Tool (DART), a structured diagnostic interview.
Time frame
6 months post enrollment4
Anxiety Symptoms - GAD-7
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.
Time frame
9 weeksOther outcomes
1
Satisfaction with the intervention - Client Satisfaction Questionnaire (CSQ-8)
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.
Time frame
9 weeks (immediately post treatment in intervention group)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
McMaster University
Lead sponsor
Ottawa Public Health
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: