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Trial record 2 of 2739 for:    CBT

Peer Administered CBT for PPD (PL-CBT)

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ClinicalTrials.gov Identifier: NCT03285139
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
Kids Can Fly Brantford
Information provided by (Responsible Party):
Ryan Van Lieshout, McMaster University

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 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

Resource links provided by the National Library of Medicine


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.



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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285139


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

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    Key Record Dates
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