An interventional study of Cognitive Behavioural Therapy in Postpartum Depression, sponsored by McMaster University. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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.
Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
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.
Time frame: 6 months
Postpartum Bonding Questionnaire
Used to detect disorders of the mother-infant relationship.
Time frame: 6 months
Social Provisions Scale
Used to measure the degree to which mothers' social relationships provide support.
Time frame: 6 months
CCHS Maternal Healthcare Utilization
Adopted from the Canadian Community Health Survey to Track use of healthcare services by mothers and their infant.
Time frame: 6 months
Adult Adolescent Parenting Inventory
Used to assess the parenting and child rearing attitudes of parents.
Time frame: 6 months
Cognitive Therapy Awareness Scale
Used to assess CBT skill and knowledge and fidelity to the CBT model.
Time frame: 6 months
Therapist Evaluation Checklist
Used to assess the quality of CBT practice.
Time frame: 6 months
EQ-5D
Used to measure health-related quality of life.
Time frame: 6 months
Generalized Anxiety Disorder-7
Used to assess generalized anxiety disorder, the most common comorbidity of postpartum depression.
Time frame: 6 months
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
Used to asses maternal depression.
Time frame: 6 months
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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