Peer Administered CBT for PPD

Postpartum Depression Clinical Trial

— PL-CBT  

Official title:

Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285139
• Other study ID #: PL CBT
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: February 28, 2020

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Cognitive Behavioural Therapy
Cognitive Behavioral Therapy 9 weekly 2-hour 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 Brantford

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 >12 is consistent with 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.	6 months
Secondary	Social Provisions Scale	Used to measure the degree to which mothers' social relationships provide support.	6 months
Secondary	CCHS 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.	6 months
Secondary	Cognitive Therapy Awareness Scale	Used to assess CBT skill and knowledge and fidelity to the CBT model.	6 months
Secondary	Therapist Evaluation Checklist	Used to assess the quality of CBT practice.	6 months
Secondary	EQ-5D	Used to measure health-related quality of life.	6 months
Secondary	Generalized Anxiety Disorder-7	Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.	6 months
Secondary	Mini International Neuropsychiatric Interview - Current Major Depressive Disorder	Used to asses maternal depression.	6 months