Online Transdiagnostic Group CBT for Postpartum Depression and Anxiety

McMaster University

Status: Active, not recruiting

Conditions: Postpartum Anxiety; Postpartum Depression (PPD)

Treatments: Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety

Study type: Interventional

Funder types: Other

Identifiers

NCT07162129

Group CBT for PPD & PPA Pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

10-week Transdiagnostic Group CBT Intervention

Experimental group

Description:

The experimental group will receive a 10-week transdiagnostic group CBT intervention delivered by a pair of trained mental health providers (psychiatrists, psychologists, social workers, nurses and/or registered psychotherapists) in addition to receiving treatment as usual.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety

Control - usual care

No Intervention group

Description:

Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed.