Group CBT for PPD in the Public Health Setting

NCT ID: NCT03039530

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-01-01

Brief Summary

Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have profound effects on mothers, their children, and their families. The cost of one case of PPD exceeds $150,000, a significant proportion of which is related to its impact on offspring. However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer than 15% of women receiving care. While Public Health Units have played an important role in PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group format is effective for treating depression in the perinatal period, and as PHNs are often the first point of contact for women experiencing PPD, with specialized training it is likely that they can deliver high-quality CBT.

The primary objective of this study is to determine if PHNs can be trained to deliver group Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence, improve mother-infant attachment and parenting and optimize infant emotional functioning.

Detailed Description

In addition to its effects on maternal health, PPD can adversely affect mother-infant attachment, parenting, and the development and health of her children. The negative effects of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive, language, and behavioral development, as well as an increased risk of emotion regulatory problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to postnatal care as usual, the investigators will proceed with a randomized controlled trial (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by trained PHNs. Those in the control group will receive standard postnatal care.

This RCT will compare the effects of group CBT to postnatal care as usual on maternal depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social support, as well as infant development, emotion regulation, and healthcare utilization

Conditions

Depression, Postpartum

Study Design

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

Study Groups

Treatment Group

Group CBT for PPD. Women in the treatment group will attend a 9-week group CBT intervention for PPD. This intervention was developed 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.

Group Type: EXPERIMENTAL

Group Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.

Control Group

Standard Care. The usual care group will receive standard care from their family physician and midwife or obstetrician. They will also be made aware of the perinatal programming available to them through Niagara Region Public Health. Women and family physicians will also receive a copy of the Canadian Practice Guidelines for the Treatment of Perinatal Depression.

Group Type: ACTIVE_COMPARATOR

Postnatal Care As Usual

Intervention Type: BEHAVIORAL

Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.

Interventions

Group Cognitive Behavioral Therapy

9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.

Intervention Type: BEHAVIORAL

Postnatal Care As Usual

Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.

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 10 and 23. They will also all be within 12 months of delivering an infant

Exclusion Criteria

• 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.

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

Sponsors

Niagara Region Public Health

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Van Lieshout, MD, PhD

Assistant Professor, Department of Psychiatry and Behavioural Neurosciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Niagara Region Public Health

Thorold, Ontario, Canada

Countries

Canada

References

Van Lieshout RJ, Layton H, Savoy CD, Haber E, Feller A, Biscaro A, Bieling PJ, Ferro MA. Public Health Nurse-delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial. Can J Psychiatry. 2022 Jun;67(6):432-440. doi: 10.1177/07067437221074426. Epub 2022 Jan 21.

Reference Type: DERIVED

PMID: 35060398 (View on PubMed)

Other Identifiers

PH CBT

Identifier Type: -

Identifier Source: org_study_id