Peer Administered Online CBT for PPD (PL-OCBT)

Online Peer-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial

Postpartum depression (PPD) affects up to one in five of women and has profound effects on mothers and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based care. This is at least partly due to significant difficulties faced by women in accessing psychotherapies, their preferred treatment for PPD. Around the world, there is a significant lack of healthcare professionals trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait-list controls) and recruit 174 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT online to women currently struggling with PPD. If peers can be trained to provide effective CBT, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy

Detailed Description

Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers and their infants. Indeed, the cost of one case of PPD is estimated to exceed $150,000. Unfortunately, fewer than 15% of women with PPD receive evidence-based care and this is at least partly due to difficulties accessing treatment, particularly those that are most preferred (e.g., psychotherapy).

Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment and that screening only occur in settings where CBT is readily available. In order to increase access to treatment, screening efforts have been undertaken by public health units across Canada. This is despite recommendations that this only be conducted in the setting of timely access to evidence-based psychotherapies (e.g., CBT). The purpose of this study is to apply task shifting to the treatment of PPD by determining if women with a past history of PPD (i.e., lay peers) living in the community can be trained to deliver effective group CBT to women with current PPD.

A group CBT intervention for PPD has been developed and validated as well as a training program that pilot data suggests is capable of successfully training public health nurses with little background psychiatric training. This intervention is brief, effective, and generalizable to women with PPD in the community. Peer administered interventions (PAIs), those delivered by recovered former patients are increasingly recognized as potentially effective alternatives to traditional mental health care services. In addition, psychotherapy delivered online has been recognized as a delivery method that results in successful expression and interpretation of emotions, decreased inhibition and reluctance to disclose personal information and a strong therapeutic alliance between patients and providers. Online psychotherapy also has satisfaction ratings that are comparable to traditional in-person psychotherapy.

Eight lay peers will be trained to deliver our 9-week group CBT treatment. 174 women will be recruited and using a randomized controlled trial design (with wait-list controls), it will be determined if lay peers can deliver effective group CBT for PPD.

If peers can be trained to provide effective CBT online, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brantford, Ontario, Canada, N3L 3E1
      • Kids Can Fly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• >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 >10
• Be within 12 months of delivering an infant
• Live within a 2-hour radius of the Brant Region.

Exclusion Criteria:

• Bipolar disorder
• Current psychotic disorder
• Substance use disorder
• Alcohol use disorder
• Antisocial or borderline personality disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention; Online Group CBT for PPD. Women in the treatment group will attend an online 9-week group Cognitive Behavioural Therapy intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton and 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. The CBT intervention will be delivered by eight lay-peers.	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioral Therapy 9 weekly 2-hour online group CBT sessions delivered by trained lay peers.
Experimental: Wait-List Controls; Online Group CBT for PPD 9 weeks after enrollment. The women in this arm of the study will receive the same Cognitive Behavioural Therapy intervention as in the immediate intervention arm, however, they will begin the CBT group 9 weeks after enrolling in the study.	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioral Therapy 9 weekly 2-hour online group CBT sessions delivered by trained lay peers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale	The EPDS will be used to assess maternal depression. A score of >10 is consistent with probable PPD and changes in scores >4 are indicative of clinically significant improvement.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder	Used to assess maternal depression.	6 months
Postpartum Bonding Questionnaire	Used to detect disorders of the mother-infant relationship. Higher scores indicate more impaired bonding.	6 months
Social Provisions Scale	Used to measure the degree to which mothers' social relationships provide support. Higher scores indicate higher levels of social support.	6 months
Canadian Community Health Survey Maternal Healthcare Utilization	Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.	6 months
Adult Adolescent Parenting Inventory	Used to assess the parenting and child rearing attitudes of parents. Higher scores indicate lower risk parenting.	6 months
EuroQol-5D	Used to measure health-related quality of life. Higher scores indicate more severe or frequent problems.	6 months
Generalized Anxiety Disorder-7	Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression. Higher scores indicate more severe generalized anxiety disorder symptoms.	6 months
Parenting Stress Index (Short-Form)	Used to measure stress in parent-child relationships. Higher scores indicate higher levels of stress.	6 months
Infant Behavior Questionnaire-Revised	Used to measure infant temperament. Higher scores indicate greater levels of the specific temperament dimension.	6 months
Ages and Stages Questionnaire	Used to measure communication and motor development in children. Higher scores indicate more positive outcomes.	6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Kids Can Fly

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: May 29, 2021
• First Submitted That Met QC Criteria: May 29, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: CBT; Postpartum depression; Lay Peer; Online therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: PL OCBT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No