Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04844138
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2021-04-05
Brief Title:
Evaluating Overcoming Anxiety in Pregnancy and Postpartum as an Online Self-Directed Program
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Evaluating a Self-Directed Cognitive Behavioural Therapy E-Health and M-Health Program for Anxiety in Pregnancy and Postpartum During COVID-19
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pregnancy and postpartum periods can be joyous times in life however they can also be filled with challenging physical emotional and lifestyle changes These changes may lead to feelings of stress anxiety and depression amongst new and expecting mothers which can have negative effects on fetal and infant development Beijers et al 2010 Goodman et al 2016 The impacts of increased worry about health and safety due to COVID-19 as well as future-related uncertainties paired with social physical distancing may be felt especially strongly in this population Of concern pregnant and postpartum women have low rates of mental health service use even prior to the pandemic Fonseca et al 2015 E-health Internet and m-health mobile application psychological interventions are accessible available at reduced cost and can be accessed within users homes a factor that is particularly important during the pandemic Andrews Titov 2010 In this study the investigators will disseminate a free online self-directed Cognitive Behavioural Therapy program to women experiencing symptoms of anxiety during pregnancy and postpartum This program has shown to be effective at improving symptoms of anxiety and depression when delivered in an in-person group format and has high acceptability Furer Reynolds 2015 The investigators will transfer this program into an online format so that pregnant and postpartum users can navigate the sessions on their own without the support of a clinician This program contains six modules which include topics such as coping with negative thoughts unpacking the myth of the supermom and managing expectations during pregnancy and postpartum Additionally material related to COVID-19 has been added to the program to target any pandemic-related stress participants may be experiencing The investigators will collect information about the programs feasibility acceptability and effectiveness which will inform future improvements to the program This program is expected to reduce participants feelings of stress anxiety and depression in addition to improving maternal attachment It is anticipated that these gains will be maintained when the investigators follow-up with participants one month after program completion This program has the potential to provide accessible and affordable mental health services to pregnant and postpartum women struggling during the pandemic
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 53294 | OTHER_GRANT | Research Manitoba | None |