Clinical Trials Directory

Trials / Completed

CompletedNCT05044455

Online Peer-Delivered Group CBT for PPD

Online Peer-Delivered Group CBT for Postpartum Depression

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
191 (actual)
Sponsor
McMaster University · Academic / Other
Sex
Female
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

Mothers and birthing parents (hereafter referred to as mothers) who have recovered from Postpartum Depression and are well now, receive training to teach a 9 week Cognitive Behavioural Therapy (CBT) treatment to mothers who are feeling depressed after giving birth in the last year. Eligible mothers are randomly assigned to one of two groups. Mothers in one group will receive a 9 week group CBT intervention delivered online by the trained Peer facilitators. Mothers in the other group will not receive the CBT group intervention and will continue to receive treatment as usual or regular care for new mothers. Mothers in both groups will complete online questionnaires three times - when participants start the study, nine weeks later and six months after that. Mothers in the intervention group will also complete a few questionnaires once during the intervention and a satisfaction questionnaire at end of intervention. Participant information will help determine if the CBT treatment is helpful for postpartum depression.

Detailed description

Mothers and birthing parents (hereafter referred to as mothers) who meet the eligibility criteria for the study (18+ years of age, with a baby under 12 months of age at recruitment, Edinburgh Postnatal Depression Scale (EPDS) score of 10 - 22 and living in Ontario are screened using the Mini International Neuropsychiatric Interview (MINI). Mothers free of bipolar, psychotic or current substance use disorders and borderline personality disorder are randomized 1:1 to the intervention (online 9 week peer-delivered CBT program) or control group (treatment as usual, TAU) after providing informed consent. Participants in the Intervention Group receive a 9 week on-line CBT group (2 hrs weekly) delivered by Peer facilitators who have recovered from Postpartum Depression (PPD) and have been trained to deliver CBT. Participants may also continue to receive treatment as usual (medication, psychotherapy), or typical care, for new mothers from any source (healthcare providers, etc). Participants in the Control Group do not receive the CBT group and are given a list of resources for mental health and postpartum depression supports and are also encouraged to seek treatment as usual or typical care for new mothers from any source. Participants will also receive follow up emails monthly with information about when to seek emergency treatment (if symptoms worsen, experience thoughts of self-harm or harm to the participant's baby). All participants will receive personalized emails with links to participant's online questionnaires through REDCap at 3 time points (recruitment, nine weeks later and 6 months later). Participants in the intervention group will also complete questionnaires at one time point during the intervention and a satisfaction survey at end of intervention. The data from both groups will be examined to determine treatment effects and durability, respectively. Peer facilitator fidelity to the CBT Model will be assessed using measures of adherence and competence and independently assessed by two raters.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioural Therapy (CBT)A 9 week CBT group, 2 hours weekly, is delivered by trained Peer facilitators to mothers randomized to this arm.

Timeline

Start date
2022-03-28
Primary completion
2023-12-31
Completion
2023-12-31
First posted
2021-09-14
Last updated
2024-04-17

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05044455. Inclusion in this directory is not an endorsement.