Peer Administered Online CBT for PPD

NCT ID: NCT04913584

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2022-02-22

Brief Summary

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.

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.

Conditions

Postpartum Depression

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy 9 weekly 2-hour online group CBT sessions delivered by trained lay peers.

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.

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy 9 weekly 2-hour online group CBT sessions delivered by trained lay peers.

Interventions

Cognitive Behavioural Therapy

Cognitive Behavioral Therapy 9 weekly 2-hour online group CBT sessions delivered by trained lay peers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kids Can Fly

UNKNOWN

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

Principal Investigators

Ryan Van Lieshout, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Kids Can Fly

Brantford, Ontario, Canada

Countries

Canada

Other Identifiers

PL OCBT

Identifier Type: -

Identifier Source: org_study_id