Online PHN CBT for PPD

NCT ID: NCT04928742

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-30
• Study Completion Date: 2022-03-02

Brief Summary

The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.

Detailed Description

A prospective, 1-site, parallel group, RCT (1:1 ratio) in which outcome assessors and data analysts will be blinded to maternal treatment will be used to compare online PHN-delivered group CBT for PPD to postnatal care as usual.

The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.

Women in the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment (9-week online CBT group)

Participants assigned to the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week. All participants in the treatment group will be mailed a hardcopy of the program manual.

Group Type: EXPERIMENTAL

Group Cognitive Behavioural Therapy (CBT)

Intervention Type: BEHAVIORAL

The 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.

Control (treatment as usual)

The control group will receive standard postnatal care from Niagara Region Public Health, their obstetrician, midwife, and/or family physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group Cognitive Behavioural Therapy (CBT)

The 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Eligible women will be >18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between of 10 or more and meet diagnostic criteria for current major depressive disorder on the Mini International Neuropsychiatric Interview-Plus (MINI-Plus). They will also all be within 12 months of delivering an infant.

Exclusion Criteria

• In order to increase the relevance and generalizability of our findings, women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder. These are predictors of significant difficulty participating in therapy groups and/or non-response to CBT.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Van Lieshout, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Van LIeshout, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

Huh K, Layton H, Savoy CD, Ferro MA, Bieling PJ, Hicks A, Van Lieshout RJ. Online Public Health Nurse-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial During the COVID-19 Pandemic. J Clin Psychiatry. 2023 Jul 24;84(5):22m14726. doi: 10.4088/JCP.22m14726.

Reference Type: DERIVED

PMID: 37498661 (View on PubMed)

Other Identifiers

OnlinePHNCBT

Identifier Type: -

Identifier Source: org_study_id