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OpenTrials
Completed

NCT Number: NCT04913584

Peer Administered Online CBT for PPD

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.

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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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Cognitive Behavioral Therapy 9 weekly 2-hour online 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 >10 is consistent with probable 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. Higher scores indicate more impaired bonding.

  2. Social Provisions Scale

    Time frame: 6 months

    Used to measure the degree to which mothers' social relationships provide support. Higher scores indicate higher levels of social support.

  3. Canadian Community Health Survey 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. Higher scores indicate lower risk parenting.

  5. EuroQol-5D

    Time frame: 6 months

    Used to measure health-related quality of life. Higher scores indicate more severe or frequent problems.

  6. Generalized Anxiety Disorder-7

    Time frame: 6 months

    Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression. Higher scores indicate more severe generalized anxiety disorder symptoms.

  7. Mini International Neuropsychiatric Interview - Current Major Depressive Disorder

    Time frame: 6 months

    Used to assess maternal depression.

  8. Parenting Stress Index (Short-Form)

    Time frame: 6 months

    Used to measure stress in parent-child relationships. Higher scores indicate higher levels of stress.

  9. Infant Behavior Questionnaire-Revised

    Time frame: 6 months

    Used to measure infant temperament. Higher scores indicate greater levels of the specific temperament dimension.

  10. Ages and Stages Questionnaire

    Time frame: 6 months

    Used to measure communication and motor development in children. Higher scores indicate more positive outcomes.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Kids Can Fly

Registry information

Official study title

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

Acronym: PL-OCBT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2021
Registry last updated
Apr 19, 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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