Peer Administered Online CBT for PPD

Postpartum Depression Clinical Trial

— PL-OCBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913584
• Other study ID #: PL OCBT
• Status: Completed
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: February 22, 2022

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

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

Locations

Country	Name	City	State
Canada	Kids Can Fly	Brantford	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Kids Can Fly

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Scale	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.	6 months
Secondary	Postpartum Bonding Questionnaire	Used to detect disorders of the mother-infant relationship. Higher scores indicate more impaired bonding.	6 months
Secondary	Social Provisions Scale	Used to measure the degree to which mothers' social relationships provide support. Higher scores indicate higher levels of social support.	6 months
Secondary	Canadian Community Health Survey Maternal Healthcare Utilization	Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.	6 months
Secondary	Adult Adolescent Parenting Inventory	Used to assess the parenting and child rearing attitudes of parents. Higher scores indicate lower risk parenting.	6 months
Secondary	EuroQol-5D	Used to measure health-related quality of life. Higher scores indicate more severe or frequent problems.	6 months
Secondary	Generalized Anxiety Disorder-7	Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression. Higher scores indicate more severe generalized anxiety disorder symptoms.	6 months
Secondary	Mini International Neuropsychiatric Interview - Current Major Depressive Disorder	Used to assess maternal depression.	6 months
Secondary	Parenting Stress Index (Short-Form)	Used to measure stress in parent-child relationships. Higher scores indicate higher levels of stress.	6 months
Secondary	Infant Behavior Questionnaire-Revised	Used to measure infant temperament. Higher scores indicate greater levels of the specific temperament dimension.	6 months
Secondary	Ages and Stages Questionnaire	Used to measure communication and motor development in children. Higher scores indicate more positive outcomes.	6 months