Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04581681
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2020-09-22
Brief Title:
Group Cognitive Behavioural Therapy CBT For Perinatal Anxiety
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Group Cognitive Behaviour Therapy for Perinatal Anxiety A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Our previous pilot study N 40 suggested that group Cognitive Behaviour Therapy for perinatal anxiety CBT-PA significantly reduces symptoms of anxiety and depression from pre- to post- intervention CBT-PA is based on the general principles of CBT but specific themes and examples are geared towards pregnancy and postpartum periods The 6-week treatment protocol addresses 1 understanding anxiety during pregnancy and postpartum 2 self-care 3 setting goals and facing fears 4 nurturing the developing relationship with baby 5 coping with negative thoughts and worries and 6 relapse prevention This intervention and all assessment interviews will be conducted via a hospital-approved video-conferencing platform All assessment questionnaires will be completed on SurveyGizmo The objectives of the present study are 1 to replicate these findings of the pilot study in a larger sample N 58 in a randomized controlled trial RCT 2 compare the effectiveness of CBT-PA to a control treatment waitlist control 3 evaluate the durability of treatment gains at 1-month and 3-months after the conclusion of treatment 4 evaluate patient preferences in terms of the relevance and the acceptability of the CBT-PA protocol 5 examine whether the degree of childbirth stress impacts patient response to CBT-PA to inform future refinements to the treatment and 6 determine whether CBT-PA improves maternal efficacy and attachment with baby This research is being conducted because many women suffer from perinatal anxiety and have difficulty accessing services in a timely manner It is the hope that the findings of this study will have clinical significance in terms of providing additional support for CBT as an effective treatment for perinatal anxiety It is the hope that this treatment will have mental and physical health benefits for the mothers directly as well as mental and physical health benefits to their fetuses and infants
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