The P3 PAAD Trial: A randomized trial testing the effectiveness of remote peer-administered therapeutic support for antenatal depressio
- Conditions
- Therapy intervention for depression in pregnant individuals (antenatal depression).Mental and Behavioural Disorders
- Registration Number
- ISRCTN51098220
- Lead Sponsor
- niversity of Calgary
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36997966/ (added 31/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 250
Participants will be included if they:
1. Are pregnant
2. Reside in the Calgary Zone of Alberta Health Services
3. Are 18 years of age or older
4. Score greater than or equal to 10 on the Edinburgh Postnatal Depression Scale, which indicates a probable depression.
5. Participants who have been on a stable dose of anti-depressant medications (SSRIs) for three months or more, prior to pregnancy are eligible to participate.
Peer counsellors will be included if they:
1. Are mothers (or the birth-giving parent), and have recovered from past antenatal depression or postpartum depression, as this will give them the peer-perspective on the experiences and needs of the intended patient population;
2. Have at least some completed post-secondary education, as this indicates the level of education adequate to understand and enact the content, theory and practical aspects of the intervention
3. Demonstrate basic understanding of mental health, and openness to evidence-based treatments for depression as this will allow for successful and ethical delivery of the intervention
Participants will be excluded if they:
1. Have a lifetime diagnosis of severe psychiatric illness (bipolar disorder, schizophrenia, borderline personality disorder, other psychoses), as these individuals need professional assistance beyond that which peer counsellors can provide.
2. Are engaged in an active treatment regimen for a diagnosed mental illness (counselling; non-SSRI medications), as this would act as a potential confounding variable
Peer counsellors will be excluded if they:
1. Screen positive for one or more of anxiety, depression or high stress, as these would preclude them from being suitable peer-counsellors
2. Cannot communicate effectively in English, as our study budget precludes the use of any translation services
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gestational age at birth in days, measured using electronic health records.
- Secondary Outcome Measures
Name Time Method 1. Symptoms of depression at T1 and T2 measured as the overall score on the EPDS; and lower odds of scoring 10 or greater on the EPDS at T2, T3, and T4.<br>2. Symptoms of anxiety across all timepoints (measured by self-report questionnaire)<br><br>Trial intake (T1), post-intervention, prior to delivery (T2), 5-6 months postpartum (T3), and 11-12 months postpartum (T4)