Cognitive behavioral therapy program for individuals with spinal cord injury
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.
This study is testing a new therapy program designed to help people with spinal cord injuries improve their mental and physical well-being through ten sessions with a team of specialists.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Roedovre) |
| Trial ID | NCT06599632 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop and test an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program specifically designed for individuals with spinal cord injuries. The study will utilize a replicated multiple baselines single-case experimental design, where nine participants will be block-randomized to different baseline phases and serve as their own controls. The intervention consists of ten sessions delivered by an interdisciplinary team, focusing on both psychological and physical rehabilitation. The trial seeks to evaluate the treatment effects and the relationships between various outcome measures over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have acquired spinal cord injuries and experience daily pain.
Not a fit: Patients with acute or sub-acute spinal cord injuries, unstable psychiatric disorders, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the psychological and physical rehabilitation outcomes for individuals with spinal cord injuries.
How similar studies have performed: While this approach is innovative, similar studies utilizing cognitive behavioral therapy for rehabilitation have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * be 18 years or older * speak and read Danish * aquired spinal cord injury * paraplegia or tetraplegia (either complete or incomplete) * daily pain * therapy-ready and motivated for this treatment type * willing to engage in homework * willing to respond to daily questionnaires * able to attend weekly sessions without payment Exclusion Criteria: * any red flags during physiotherapeutic examination * acute or sub-acute stage * current pressure ulcers * known and unstable psychiatric disorder * syringomyelia * pregnancy
Where this trial is running
Roedovre
- Specialized Hospital for Polio and Accident Victims — Roedovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Tonny E Andersen, PhD — University of Southern Denmark
- Study coordinator: Anders O Aaby, PhD
- Email: aaaby@health.sdu.dk
- Phone: 004520746262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.