Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT06599632
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2024-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Traumatic Spinal Cord Injury
Sponsor:
University of Southern Denmark
Organization:
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:
COMPLETED
Status Verified Date:
2025-12
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:
VALIANT
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 either in person at Specialized Hospital for Polio and Accident Victims or virtually via secure videoconferencing 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 either in person at Specialized Hospital for Polio and Accident Victims or virtually via secure videoconferencing 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:
True
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?: