Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04335643
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-26
First Post:
2020-02-27
Brief Title:
Telehealth CBT for Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus
Sponsor:
Michigan State University
Organization:
Michigan State University
Study Overview
Official Title:
A Remotely Delivered CBT Intervention for Youth With cSLE A Multi-site Patient-engaged Investigation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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:
cSLE
Brief Summary:
This study aims to investigate the feasibility and effectiveness of a remotely delivered psychological intervention for youth with cSLE This intervention aims to teach participants skills in order to cope with fatigue pain and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus
Detailed Description:
This project is investigating whether a remotely delivered psychological intervention is acceptable and beneficial to teens and young adults coping with cSLE This study uses a cognitive behavioral therapy CBT intervention called the Treatment and Education Approach for Childhood-onset Lupus TEACH to address symptoms of fatigue depression and pain that commonly occur in individuals with cSLE The TEACH program includes six-weekly one hour sessions conducted over HIPAA-compliant video conferencing
Participation in this study will take approximately 8-15 weeks with a follow-up survey occurring 3-months after post-assessment and a long-term follow-up survey occurring between 12-27 months after post-assessment After qualifying for the study participants will be randomly selected like flipping a coin to the TEACH program plus medical treatment as usual TAU OR medical TAU alone for six weeks After this six-week time period a post-assessment will be completed Participants that only continued medical TAU will then be eligible to receive TEACH after completing the post-assessment If these participants choose to undergo the TEACH treatment they will be asked to complete a short interview about the program and answer questions about how their mood pain and fatigue
Participation in this study will take approximately 8-15 weeks with a follow-up survey occurring 3-months after post-assessment and a long-term follow-up survey occurring between 12-27 months after post-assessment After qualifying for the study participants will be randomly selected like flipping a coin to the TEACH program plus medical treatment as usual TAU OR medical TAU alone for six weeks After this six-week time period a post-assessment will be completed Participants that only continued medical TAU will then be eligible to receive TEACH after completing the post-assessment If these participants choose to undergo the TEACH treatment they will be asked to complete a short interview about the program and answer questions about how their mood pain and fatigue
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