Clinical trial NCT04913584: Peer Administered Online CBT for PPD
Official title: Online Peer-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: Postpartum depression
CBT
Lay Peer
Online therapy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Kids Can Fly
First posted: 2021-06-04
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 months
Secondary outcomes:
measure: Postpartum Bonding Questionnaire
timeFrame: 6 months
measure: Social Provisions Scale
timeFrame: 6 months
measure: Canadian Community Health Survey Maternal Healthcare Utilization
timeFrame: 6 months
measure: Adult Adolescent Parenting Inventory
timeFrame: 6 months
measure: EuroQol-5D
timeFrame: 6 months
measure: Generalized Anxiety Disorder-7
timeFrame: 6 months
measure: Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
timeFrame: 6 months
measure: Parenting Stress Index (Short-Form)
timeFrame: 6 months
measure: Infant Behavior Questionnaire-Revised
timeFrame: 6 months
measure: Ages and Stages Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Brantford
country: Canada
facility: Kids Can Fly
state: Ontario
Study officials:
affiliation: McMaster University
name: Ryan Van Lieshout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: