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OpenTrials
Completed

NCT Number: NCT03285139

Peer Administered CBT for PPD

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kids Can Fly

Brantford, Ontario, N3L 3E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 commodities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

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

Primary outcomes

  1. 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

  1. Postpartum Bonding Questionnaire

    Time frame: 6 months

    Used to detect disorders of the mother-infant relationship.

  2. Social Provisions Scale

    Time frame: 6 months

    Used to measure the degree to which mothers' social relationships provide support.

  3. CCHS Maternal Healthcare Utilization

    Time frame: 6 months

    Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.

  4. Adult Adolescent Parenting Inventory

    Time frame: 6 months

    Used to assess the parenting and child rearing attitudes of parents.

  5. Cognitive Therapy Awareness Scale

    Time frame: 6 months

    Used to assess CBT skill and knowledge and fidelity to the CBT model.

  6. Therapist Evaluation Checklist

    Time frame: 6 months

    Used to assess the quality of CBT practice.

  7. EQ-5D

    Time frame: 6 months

    Used to measure health-related quality of life.

  8. Generalized Anxiety Disorder-7

    Time frame: 6 months

    Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.

  9. Mini International Neuropsychiatric Interview - Current Major Depressive Disorder

    Time frame: 6 months

    Used to asses maternal depression.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Kids Can Fly Brantford

Registry information

Official study title

Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression

Acronym: PL-CBT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 15, 2017
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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