Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05040581
Other study ID # 1DayPrev
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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: 1. The treatment manual for the workshop is acceptable to women 2. 15 women are recruited into a pilot workshop within three months and have 70% complete their follow-up measures 3. Recruit and randomize 60 women over six months into two separate workshop/info sessions (each consisting of 15 in the workshop and 15 into the control information session) and: 1. 70% of eligible sign-ups enroll in the study 2. 75% of participants assigned to experimental group complete intervention 3. 70% of participants complete all follow-up measures 4. Estimate a treatment effect and variance (measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module and the Edinburgh Postnatal Depression Scale)


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - >28 weeks pregnant - do not meet diagnostic criteria for a current major depressive episode (determined using the Mini International Neuropsychiatric Interview (MINI)) - Presence of one or more of the following risk factors for PPD: - Past history of major depressive disorder or generalized anxiety disorder (Mini International Neuropsychiatric Interview (MINI)) - Low SES (Canadian Household Low Income Cut-Off (LICOs) Before Tax) - Single marital status (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) - Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) - Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) - History of physical and/or sexual abuse (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) - Perceived low social support (Antenatal (Psychosocial) Risk Questionnaire (ANRQ)) Exclusion Criteria: - Bipolar, psychotic and/or current substance use disorders (determined using the Mini International Neuropsychiatric Interview (MINI))

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
1-Day CBT-Based Workshop for Preventing PPD
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.

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of developed treatment manual this outcome will be assessed using open-ended questions in an electronic survey to elicit participant feedback 6 months
Primary Feasibility of recruiting 15 mothers into a pilot workshop counts will be used to determine the number of participants recruited into the pilot workshop 6 months
Primary Feasibility of recruiting 60 participants into pilot RCT in 6 months counts will be used to determine the number of participants recruited into the pilot RCT 6 months
Primary Proportion of eligible participants who enroll in study counts will be used to determine the proportion of eligible participants who enroll in the study 6 months
Primary Proportion of participants in experimental arm who complete intervention counts will be used to determine the proportion of participants who complete the intervention 6 months
Primary Proportion of participants who complete all outcome measures Counts will be used to determine the number of participants who complete the outcome measures 6 months
Secondary Estimate of treatment effect and variance of primary outcome for later RCT - Major Depressive Disorder Measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module to determine if participants meet diagnostic criteria for PPD measured at 1, 2, and 3 months postpartum
Secondary Estimate of treatment effect and variance of primary outcome for later RCT - Depressive Symptoms 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. measured at 1, 2, and 3 months postpartum
See also
  Status Clinical Trial Phase
Recruiting NCT05322161 - Yoga in the NICU for Parents Study N/A
Withdrawn NCT03709004 - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression N/A
Completed NCT06305325 - Coparenting Intervention to Prevent Postpartum Depression N/A
Not yet recruiting NCT05055674 - The Effects of Motherly on Postpartum Depression N/A
Enrolling by invitation NCT02323152 - PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK N/A
Not yet recruiting NCT01658098 - Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez N/A
Completed NCT00961402 - The Effect of Exercise on Preventing PostPartum Depression Phase 2
Completed NCT01312883 - Mothers Avoiding Depression Through Empowerment Intervention Trial N/A
Completed NCT00360204 - Improving Health Outcomes for New Mothers and Babies Phase 3
Unknown status NCT00548743 - Translating Research Into Practice for Postpartum Depression N/A
Completed NCT04146025 - Nurtured in Nature N/A
Recruiting NCT05137925 - Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum N/A
Not yet recruiting NCT05299398 - Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone Phase 1
Completed NCT04925765 - Virtual Reality Biofeedback for Postpartum Anxiety and Depression N/A
Recruiting NCT06053515 - Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication N/A
Completed NCT04037085 - Ketamine to Improve Recovery After Cesarean Delivery - Part 1 Phase 2
Completed NCT05059600 - A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting Phase 4
Recruiting NCT06136520 - The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression N/A
Recruiting NCT05038085 - Postpartum Depression and Maternal Attachment N/A
Not yet recruiting NCT06273423 - Feasibility Evaluation of a Dance Fitness Program N/A