Peer Administered CBT for PPD (PL-CBT)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Postpartum Depression	Behavioral: Cognitive Behavioural Therapy	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	148 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression
Actual Study Start Date :	January 3, 2018
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Immediate Intervention; Group CBT for PPD. Women in the treatment group will attend a 9-week group Cognitive Behavioural Therapy intervention for PPD. This intervention was developed at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton and designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week. The CBT intervention will be delivered by lay-peers.	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
Experimental: Wait List Controls; Group CBT for PPD 9 weeks after enrollment. The women in this arm of the study will receive the same Cognitive Behavioural Therapy intervention as in the immediate intervention arm, however they will begin the CBT group 9 weeks after enrolling in the study.	Behavioral: Cognitive Behavioural Therapy; Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
No Intervention: Healthy Controls; No treatment. The participants in this arm of the study will not be suffering from postpartum depression and will not receive the Cognitive Behavioural Therapy treatment. Healthy controls will complete study measures upon enrollment in the study, 9 weeks later as well as 6 months later.

Outcome Measures

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Primary Outcome Measures :

1. Edinburgh Postnatal Depression Scale [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. Postpartum Bonding Questionnaire [ Time Frame: 6 months ]
   Used to detect disorders of the mother-infant relationship.
2. Social Provisions Scale [ Time Frame: 6 months ]
   Used to measure the degree to which mothers' social relationships provide support.
3. CCHS 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.
5. Cognitive Therapy Awareness Scale [ Time Frame: 6 months ]
   Used to assess CBT skill and knowledge and fidelity to the CBT model.
6. Therapist Evaluation Checklist [ Time Frame: 6 months ]
   Used to assess the quality of CBT practice.
7. EQ-5D [ Time Frame: 6 months ]
   Used to measure health-related quality of life.
8. Generalized Anxiety Disorder-7 [ Time Frame: 6 months ]
   Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.
9. Mini International Neuropsychiatric Interview - Current Major Depressive Disorder [ Time Frame: 6 months ]
   Used to asses maternal depression.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Ryan Van Lieshout, MD, PhD	905-522-1155 ext 35123	vanlierj@mcmaster.ca

Locations

Canada, Ontario
Kids Can Fly	Recruiting
Brantford, Ontario, Canada, N3L 3E1

Sponsors and Collaborators

McMaster University

Kids Can Fly Brantford

Investigators

Principal Investigator:	Ryan Van Lieshout, MD, PhD	McMaster University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ryan Van Lieshout, Assistant Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University
ClinicalTrials.gov Identifier:	NCT03285139 History of Changes
Other Study ID Numbers:	PL CBT
First Posted:	September 15, 2017
Last Update Posted:	March 26, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Ryan Van Lieshout, McMaster University:

Postpartum depression; CBT; Lay Peer

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depression, Postpartum; Behavioral Symptoms	Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications