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

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.

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury (SCI)
• Intervention / Treatment: Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Rødovre Municipality, Denmark, 2610
    • Specialized Hospital for Polio and Accident Victims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value-based living	Single item measure based on Engaged Living Scale. Scored on a scale from 0 to 10. Higher scores means greater levels of value-based living.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain interference	Three single items focused specifically on general activities, relations with other people, and sleep. Based on Brief Pain Inventory. All three are scored on a scale from 0 to 10. Higher scores means greater levels of pain interference.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Value-based living	Engaged Living Scale. 16 item scale. Scored on a scale from 1 to 5. Higher total scores indicate greater levels of value-based living.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain interference	Brief Pain Inventory. 7 item scale. Scored on a scale from 0 to 10. Higher total scores indicate greater pain interference.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain catastrophizing	Single item measure based on Daily Pain Catastrophizing Scale). Scored on a scale from 0 to 10. Higher scores means greater levels of pain catastrophizing.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Positive affect	Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of positive affect.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Negative affect	Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of negative affect.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Stress	Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of stress.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Fatigue	Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of fatigue.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain-related acceptance	Single item measure based on Chronic Pain Acceptance Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of acceptance.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain severity	Single item measure based on Brief Pain Inventory. Scored on a scale from 0 to 10. Higher scores means greater levels of pain severity.	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Depression	Patient Health Questionnaire (PHQ-9). 9 item scale. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of depression.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Anxiety	Generalized Anxiety Disorder (GAD-7). 7 items. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of anxiety.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Stress	Perceived Stress Scale. 10 items. Scored on a 5-point scale. Higher total scores indicate greater levels of stress.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Health-related quality of life	EuroQoL-5D-5L. 5 items scored on a 5-point scale and one item scored on a 0 to 100 scale. Higher scores on the first 5 items indicate reduced quality of life and higher scores on the last item indicates greater quality of life.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain-related acceptance	Chronic Pain Acceptance Questionnaire (CPAQ-8). 8 items scored on a scale from 0 to 6. Higher total scores indicate greater levels of acceptance.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain-related self-efficacy	Pain Self-Efficacy Questionnaire. 2 items scored on a scale from 0 to 6. Higher scores indicate greater self-efficacy.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Sleep quality	Karolinska Sleep Questionnaire. 4 items scores on a scale from 0 to 5. Higher total scores indicates poorer quality of sleep.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Self-perceived improvement	Global Rating of Change. 1 item scored on a scale from 1 to 15. Higher scores indicate greater level of self-perceived improvement.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Satisfaction with treatment	Self-developed NRS-item from 0 = not at all satisfied to 10 = completely satisfied.	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain-related self-efficacy	Single item measure based on Pain Self-efficacy Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of self-efficacy	Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain Disability	Pain Disability Index. 7 items scored on a scale from 0 to 10. Higher total scores indicate greater disability	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain severity	Four 0-10 numeric rating scale (NRS) for worst, mildest, average, and current pain. Scored on a scale from 0 to 10. Higher scores indicate greater levels of pain severity	Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Principal Investigator: Tonny E Andersen, PhD, University of Southern Denmark; Study Director: Sophie L Ravn, PhD, University of Southern Denmark; Study Director: Anders O Aaby, PhD, University of Southern Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Actual): October 17, 2025
• Study Completion (Actual): October 17, 2025

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2110041(SCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No