Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Traumatic Spinal Cord Injury (VALIANT)

University of Southern Denmark (SDU)

Status: Completed

Conditions: Spinal Cord Injury (SCI)

Treatments: Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06599632

2110041(SCI)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Baseline phase

Experimental group

Description:

There are three baseline phases of 1, 2, or 3 weeks to which participants are block-randomized followed by a 10-week intervention phase. Hence, participants are their own case-controls.

Treatment:

Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)