Postpartum Anxiety, Postpartum Depression (PPD)
Conditions
Keywords
Transdiagnostic, Postpartum Depression, Postpartum Anxiety, Cognitive Behavioural Therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety
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.
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 (CBT group) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * have an infant \<12 months at recruitment * fluent in written/spoken English * have an EPDS score ≥10 and/or a GAD-7 score≥10 * live in Ontario, Canada
Exclusion criteria
* does not meet diagnostic criteria for bipolar, psychotic, borderline personality and current substance use disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete the intervention (adherence) | 6 months | 80% of participants in treatment group complete the intervention |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS) | 10 weeks | 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. |
| Estimate Treatment effect - GAD-7 | 10 weeks | 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. |
Countries
Canada
Outcome results
None listed