Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599632
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Spinal Cord Injury VALIANT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Spinal Cord Injury After Road Traffic Accidents Protocol for a Multiple Baselines Single-case Experimental Design
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy V-CBT program for individuals with spinal cord injury The main question it aims to answer are
What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy V-CBT program on individuals with spinal cord injury
What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program
Participants will undergo a replicated multiple baselines single-case experimental design SCED Nine participants who meet specific eligibility criteria will be block-randomized to a 1 2 or 3-week baseline phase serving as their own controls The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions focusing on psychological and physical rehabilitation Participants will be required to attend these sessions as part of the treatment protocol Data collection includes daily online self-reports and comprehensive measurements at pre-treatment post- treatment and a three-month follow-up
What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy V-CBT program on individuals with spinal cord injury
What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program
Participants will undergo a replicated multiple baselines single-case experimental design SCED Nine participants who meet specific eligibility criteria will be block-randomized to a 1 2 or 3-week baseline phase serving as their own controls The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions focusing on psychological and physical rehabilitation Participants will be required to attend these sessions as part of the treatment protocol Data collection includes daily online self-reports and comprehensive measurements at pre-treatment post- treatment and a three-month follow-up
Detailed Description:
None
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