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Peer Administered CBT for PPD

Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03285139
Acronym
PL-CBT
Enrollment
73
Registered
2017-09-15
Start date
2018-01-03
Completion date
2020-02-28
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression

Keywords

Postpartum depression, CBT, Lay Peer

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.

Interventions

BEHAVIORALCognitive Behavioural Therapy

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

Sponsors

Kids Can Fly Brantford
CollaboratorUNKNOWN
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Edinburgh Postnatal Depression Scale6 monthsThe 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

MeasureTime frameDescription
Therapist Evaluation Checklist6 monthsUsed to assess the quality of CBT practice.
Adult Adolescent Parenting Inventory6 monthsUsed to assess the parenting and child rearing attitudes of parents.
Cognitive Therapy Awareness Scale6 monthsUsed to assess CBT skill and knowledge and fidelity to the CBT model.
Postpartum Bonding Questionnaire6 monthsUsed to detect disorders of the mother-infant relationship.
EQ-5D6 monthsUsed to measure health-related quality of life.
CCHS Maternal Healthcare Utilization6 monthsAdopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.
Generalized Anxiety Disorder-76 monthsUsed to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder6 monthsUsed to asses maternal depression.
Social Provisions Scale6 monthsUsed to measure the degree to which mothers' social relationships provide support.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026