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The P3 PAAD Trial: A randomized trial testing the effectiveness of remote peer-administered therapeutic support for antenatal depression

Effect of remote, Peer-Administered behavioural Activation and peer-support intervention for Antenatal Depression on gestational age at delivery: the single-blind, randomized control PAAD trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51098220
Enrollment
250
Registered
2022-04-08
Start date
2022-04-11
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapy intervention for depression in pregnant individuals (antenatal depression). Mental and Behavioural Disorders

Interventions

A two-arm, single-blinded, parallel groups randomized controlled trial with repeated measures will be conducted. Participants scoring >10 on the Edinburgh Postnatal Depression Scale will be recruited

Sponsors

University of Calgary
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Gestational age at birth in days, measured using electronic health records.

Secondary

MeasureTime frame
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. 2. Symptoms of anxiety across all timepoints (measured by self-report questionnaire) Trial intake (T1), post-intervention, prior to delivery (T2), 5-6 months postpartum (T3), and 11-12 months postpartum (T4)

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026