Skip to main content
Clinical Trials/NCT03285139
NCT03285139
Completed
Not Applicable

Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression

McMaster University1 site in 1 country73 target enrollmentJanuary 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Depression
Sponsor
McMaster University
Enrollment
73
Locations
1
Primary Endpoint
Edinburgh Postnatal Depression Scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Postpartum depression (PPD) affects up to 20% 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 cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present, there is a significant lack of personnel trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait list controls) and recruit 70 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT to women with current 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 province-wide. 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 community. Peer administered interventions (PAIs), those delivered by recovered former patients are increasingly recognized as potentially effective alternatives to traditional mental health care services. Eight lay peers will be trained to deliver our 9-week group CBT treatment. 74 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, 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.

Registry
clinicaltrials.gov
Start Date
January 3, 2018
End Date
February 28, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ryan Van Lieshout, MD, PhD

Assistant Professor, Department of Psychiatry and Behavioural Neurosciences

McMaster University

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
  • They will also all be within 12 months of delivering an infant.

Exclusion Criteria

  • Women can have psychiatric commodities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.

Outcomes

Primary Outcomes

Edinburgh Postnatal Depression Scale

Time Frame: 6 months

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.

Secondary Outcomes

  • Generalized Anxiety Disorder-7(6 months)
  • Postpartum Bonding Questionnaire(6 months)
  • Social Provisions Scale(6 months)
  • Adult Adolescent Parenting Inventory(6 months)
  • Therapist Evaluation Checklist(6 months)
  • EQ-5D(6 months)
  • CCHS Maternal Healthcare Utilization(6 months)
  • Cognitive Therapy Awareness Scale(6 months)
  • Mini International Neuropsychiatric Interview - Current Major Depressive Disorder(6 months)

Study Sites (1)

Loading locations...

Similar Trials