McMaster University
Hamilton, Ontario, L8S 4L8, Canada
NCT Number: NCT05040581
The aim of this pilot study is to (1) develop a treatment manual for a 1-Day CBT-Based Workshop for preventing postpartum depression that is acceptable to women; (2) recruit 15 women into a pilot workshop and seek their feedback on content, delivery and assessment procedures; and (3) conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD.
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Notify Me18 year and older
Female
Interventional
Not applicable
Hamilton, Ontario, L8S 4L8, Canada
Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given high rates of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.
Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators will develop the content for our prevention workshop as well as an accompanying script and intervention manual for participants (Objective 1). They will then advertise and assess the feasibility of recruiting 15 women into a pilot workshop and seek their feedback on its content, delivery and assessment procedures (Objective 2). Using these data, the workshop will be revised, and the investigators will conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD (Objective 3).
These objectives will enable us to develop and deliver this intervention, assess the feasibility of our recruitment strategy, determine recruitment and retention rates, assess study personnel needs, refine the study protocol and estimate effect sizes for group differences in support of a larger, full-scale trial aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.
The pilot study will be considered successful and proceed to a larger trial in the future if:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is a 6-hour long CBT-based workshop. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning.
Time frame: 6 months
this outcome will be assessed using open-ended questions in an electronic survey to elicit participant feedback
Time frame: 6 months
counts will be used to determine the number of participants recruited into the pilot workshop
Time frame: 6 months
counts will be used to determine the number of participants recruited into the pilot RCT
Time frame: 6 months
counts will be used to determine the proportion of eligible participants who enroll in the study
Time frame: 6 months
counts will be used to determine the proportion of participants who complete the intervention
Time frame: 6 months
Counts will be used to determine the number of participants who complete the outcome measures
Time frame: measured at 1, 2, and 3 months postpartum
Measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module to determine if participants meet diagnostic criteria for PPD
Time frame: measured at 1, 2, and 3 months postpartum
Measured using the Edinburgh Postnatal Depression Scale (EPDS) to assess level of depressive symptoms. The EPDS is a self-report measure that produces scores ranging from 0-30, with higher scores indicating higher levels of depressive symptoms. Scores of 13 or more suggest probable PPD.
McMaster University
Other
Online 1-Day Cognitive Behavioural Therapy-Based Workshops for Preventing Postpartum Depression: A Pilot Study
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