Clinical trial NCT03654261: 1-Day CBT Workshops for PPD
Official title: 1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: Cognitive Therapy
Workshop
Postpartum Depression
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 461
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

Detailed description: Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).

Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.

A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

If this intervention is eventually proven effective, 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.

Eligibility criteria: Inclusion Criteria:

* infant \<12 months
* 18 years or older
* EPDS score \>10

Exclusion Criteria:

-

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 3 months
measure: Beck Depression Inventory-II
timeFrame: 3 months
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 3 months
measure: Postpartum Bonding Questionnaire
timeFrame: 3 months
measure: Client Satisfaction Questionnaire
timeFrame: Immediately after workshop
measure: Healthcare Utilization
timeFrame: 3 months
measure: Infant Behaviour Questionnaire-Revised (Very short form)
timeFrame: 3 months
measure: Strengths and Difficulties Questionnaire
timeFrame: 3 months
measure: Early Childhood Behaviour Questionnaire (very short form)
timeFrame: 3 months
measure: EQ-5D
timeFrame: 3 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Ryan Van Lieshout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Layton H, Owais S, Savoy CD, Van Lieshout RJ. Depression, Anxiety, and Mother-Infant Bonding in Women Seeking Treatment for Postpartum Depression Before and During the COVID-19 Pandemic. J Clin Psychiatry. 2021 Jul 6;82(4):21m13874. doi: 10.4088/JCP.21m13874.