Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569875
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Feasibility Study Self-guided iCBT for Mothers With Postpartum Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Study Self-guided Internet-based Cognitive Behavioral Therapy as a Stepped-care Treatment for Mothers With Postpartum Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to conduct a feasibility study to test the study procedure and a newly developed self-guided internet-based cognitive behavioral therapy program for mothers with postpartum depression
Detailed Description:
The aim of the feasibility study is twofold 1 to test the feasibility of the study and 2 to test the acceptability of the internet-based cognitive behavioral therapy program and to minimize dropout
The study will be conducted as a mixed-method process evaluation Twenty mothers will be included in the study After being informed about the study and its potential all patients who give written informed consent will be randomized in a 11 ratio into either the control group receiving treatment as usual or the intervention group receiving treatment as usual plus the iCBT program iCARE The intervention period will last for two months
After the intervention period investigators will use a survey distributed from REDCap to measure its feasibility participants satisfaction with it and acceptability
After the two-month intervention period semi-structured interviews will be conducted with participants from both the intervention and control groups to gather qualitative insights This feasibility study will also provide a preliminary evaluation of the interventions impact The findings from this pilot study will inform the design of the subsequent randomized controlled trial RCT and guide any necessary modifications to the treatment program and associated procedures
The study will be conducted as a mixed-method process evaluation Twenty mothers will be included in the study After being informed about the study and its potential all patients who give written informed consent will be randomized in a 11 ratio into either the control group receiving treatment as usual or the intervention group receiving treatment as usual plus the iCBT program iCARE The intervention period will last for two months
After the intervention period investigators will use a survey distributed from REDCap to measure its feasibility participants satisfaction with it and acceptability
After the two-month intervention period semi-structured interviews will be conducted with participants from both the intervention and control groups to gather qualitative insights This feasibility study will also provide a preliminary evaluation of the interventions impact The findings from this pilot study will inform the design of the subsequent randomized controlled trial RCT and guide any necessary modifications to the treatment program and associated procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None