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

NCT ID: NCT06599632

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2025-10-17

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.

Conditions

Spinal Cord Injury (SCI)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baseline phase

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.

Group Type: EXPERIMENTAL

Values-based Cognitive Behavioral Therapy (V-CBT)

Intervention Type: BEHAVIORAL

The intervention offers a 10-session treatment for spinal cord injury (SCI). The manualized adapted version of value-based cognitive behavioral treatment (V-CBT) is conducted by interdisciplinary teams of psychologists and physiotherapists. The program, based on V-CBT principles, focuses on psychoeducation, fostering self-efficacy, and setting value-based goals in the initial three sessions. The subsequent seven sessions involve physiotherapists trained in V-CBT, addressing psychological, physical, social, and practical barriers hindering engagement in participants lives. Each session combines psychologically informed themes and supervised exercises, aiming to enhance engagement in values-based activities.

Interventions

Values-based Cognitive Behavioral Therapy (V-CBT)

The intervention offers a 10-session treatment for spinal cord injury (SCI). The manualized adapted version of value-based cognitive behavioral treatment (V-CBT) is conducted by interdisciplinary teams of psychologists and physiotherapists. The program, based on V-CBT principles, focuses on psychoeducation, fostering self-efficacy, and setting value-based goals in the initial three sessions. The subsequent seven sessions involve physiotherapists trained in V-CBT, addressing psychological, physical, social, and practical barriers hindering engagement in participants lives. Each session combines psychologically informed themes and supervised exercises, aiming to enhance engagement in values-based activities.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anders Orup Aaby

Guest researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tonny E Andersen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Sophie L Ravn, PhD

Role: STUDY_DIRECTOR

University of Southern Denmark

Anders O Aaby, PhD

Role: STUDY_DIRECTOR

University of Southern Denmark

Locations

Specialized Hospital for Polio and Accident Victims

Rødovre Municipality, , Denmark

Countries

Denmark

References

Aaby AO, Andersen TE, Ravn SL. Interdisciplinary value-based cognitive behavioral treatment for people with persistent pain after posttraumatic spinal cord injury (project VALIANT): protocol for an intervention study using multiple baselines single-case experimental design. BMC Psychol. 2025 Nov 24;13(1):1294. doi: 10.1186/s40359-025-03637-5.

Reference Type: DERIVED

PMID: 41287070 (View on PubMed)

Other Identifiers

2110041(SCI)

Identifier Type: -

Identifier Source: org_study_id