Group CBT for PPD in the Public Health Setting

NCT03039530 | Completed

• 1 other identifier: PH CBT
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Postpartum

Keywords

Postpartum Depression; Cognitive Behavioral Therapy; Public Health; Mother; Infant; Emotion

Outcome Measures

Primary Outcomes (2)

• Edinburgh Postnatal Depression Scale (EPDS)

  The EPDS will be used to assess maternal depression. A score of \>12 is consistent with PPD and changes in scores \>4 are indicative of clinically significant improvement.

  6 months

• Mini International Neuropsychiatric Interview - Current Major Depressive Disorder

  Used to assess maternal depression.

  6 months

Secondary Outcomes (11)

• Penn State Worry Questionnaire (PSWQ)

  6 months

• Postpartum Bonding Questionnaire

  6 months

• Parent-Child Early Relational Assessment

  6 months

• Social Provisions Scale

  6 months

• Ages and Stages Questionnaires - Third Edition

  6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Behavioral: Group Cognitive Behavioral Therapy

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Postnatal Care As Usual

Interventions

Group Cognitive Behavioral Therapy BEHAVIORAL

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

Treatment Group

Postnatal Care As Usual 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Niagara Region Public Health: collaborator

Study Sites (1)

Niagara Region Public Health

Thorold, Ontario, L2V 4Y6, Canada

Location

Related Publications (1)

• 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.

  PMID: 35060398 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Postnatal Care

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Perinatal Care; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioural Neurosciences

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: February 1, 2017
• Study Start: April 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

CA (1)