Fathers, Perinatal Depression
Conditions
Keywords
cognitive behavioral therapy, paternal depression, perinatal depression, fathers
Brief summary
The purpose of this pilot randomized controlled trial is to assess the feasibility of offering a 9-week group cognitive behavioural therapy (CBT; a type of talking therapy) led by a psychiatrist and public health nurse to fathers and non-birthing parents who identify as fathers or fathers-to-be (have a partner who is expecting) with perinatal depression. Fathers or fathers-to-be living in Ontario 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.
Detailed description
This study will involve a pilot randomized controlled trial (RCT) to determine the feasibility of the intervention and study protocol for assessing if a 9-week group CBT intervention added to treatment as usual (TAU) can improve paternal perinatal depression symptoms more than TAU alone. The primary objective is to assess feasibility of the intervention including recruitment, completion of study measures, retention, and participant satisfaction/acceptability of the intervention. The secondary objective of the RCT is to estimate treatment effects on depressive symptoms to guide the conduct of a future full-scale RCT of the intervention. Estimate of treatment effect will serve as a primary outcome measure in a later full-scale RCT. Forty-eight 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.
Interventions
Cognitive 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.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
Intervention model description
A parallel-group Ontario-wide RCT with experimental (9-week CBT + TAU) and control (TAU) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers with an infant \<18 months at recruitment, be fluent in written/spoken English, have an EPDS score ≥9 and live in Ontario
Exclusion criteria
* Free of bipolar, psychotic, borderline personality and current substance use disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants recruited in recruitment period | 6 months | Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months |
| Number of participants who complete all data collection procedures | 6 months | 75% of participants complete all three questionnaires and structured interviews |
| Number of participants who complete study (retention) | 6 months | 75% of participants remain in study until completion |
| Number of participants who complete the intervention (adherence) | 6 months | 80% of participants in treatment group complete the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate treatment effect - Edinburgh Postnatal Depression Scale (EPDS) | 9 weeks | Perinatal depression (PND) is best conceptualized as a continuous construct with its impact operating across a continuum of severity, and so a continuous measure of PND (EPDS) is our primary outcome. In keeping with most PND RCTs, our primary effectiveness time point is immediately post-treatment (T2). We will also assess the durability of intervention effects at three months post-T2 (T3). 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. |
Countries
Canada
Outcome results
None listed