The purpose of this pilot study is to test the feasibility of an online 10-Week group cognitive behavioural therapy (CBT; a type of talking therapy) intervention for postpartum depression and anxiety that is led by psychotherapists, social workers, a psychologist and/or a psychiatrist. Mothers and birthing parents who are 18 years or older, have an infant under 12 months, living in Ontario and who have postpartum depression and/or anxiety symptoms will be assigned with a 50/50 chance (like flipping a coin) to receive online transdiagnostic group CBT in addition to usual postnatal care, or to receive usual postnatal care only.
This study will involve a pilot randomized controlled trial (RCT) to determine the feasibility of a 10-week group CBT intervention for treating postpartum depression and anxiety and study procedures. Primary feasibility objectives include recruitment, completion of study measures, retention and participant satisfaction/acceptability of the intervention. The secondary objective of the pilot RCT is to estimate the treatment effects on PPD and anxiety symptoms to guide the conduct of a future full-scale RCT of the intervention. 48 Participants will be assigned in a 1:1 ratio to the experimental (transdiagnostic CBT group plus treatment as usual (TAU)) or control group (TAU alone). Participants in both groups will complete all study questionnaires at baseline (T1), 10 weeks later (T2 - immediately post-intervention in the experimental group to assess effectiveness), and 6 months after enrollment (T3 - intervention durability). Participants in the treatment group will complete a satisfaction questionnaire with three open-ended questions that will explore their experiences and recommendations for improving the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). Each session will be two hours in duration. The 1st hour involves teaching and practice of CBT skills followed by one hour of unstructured discussion about topics relevant to PPD and PPA (sleep, supports, transitions). Each group will be delivered online via Zoom and guided by our intervention manual.
McMaster University
Hamilton, Ontario, Canada
Number of participants recruited in recruitment period
Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months
Time frame: 6 months
Number of participants who complete all data collection procedures
75% of participants complete all three questionnaires and structured interviews
Time frame: 6 months
Number of participants who complete study (retention)
75% of participants remain in study until completion
Time frame: 6 months
Number of participants who complete the intervention (adherence)
80% of participants in treatment group complete the intervention
Time frame: 6 months
Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)
Postpartum depression (PPD) is best conceptualized as a continuous construct with its impact operating across a continuum of severity, and so a continuous measure of PPD (EPDS) is our primary outcome. In keeping with most PPD RCTs, our primary effectiveness timepoint is immediately post-treatment (T2). The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score of ≥10 is consistent with possible PPD, ≥13 is consistent with probable PPD and changes in scores \>4 are accepted as being indicative of clinically significant change.
Time frame: 10 weeks
Estimate Treatment effect - GAD-7
A reliable and valid 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common comorbidity of PPD. A cutoff of ≥10 defines clinically important levels of anxiety symptoms and changes in scores \>4 are accepted as being indicative of clinically significant change.
Time frame: 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.