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

NCT06599632 | Completed DMC

• 1 other identifier: 2110041(SCI)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (19)

• Pain catastrophizing

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Positive affect

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Negative affect

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Stress

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Fatigue

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

Study Arms (1)

Baseline phase

EXPERIMENTAL

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)

Interventions

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

Baseline phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• any red flags during physiotherapeutic examination
• acute or sub-acute stage
• current pressure ulcers
• known and unstable psychiatric disorder
• syringomyelia
• pregnancy

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Specialized Hospital for Polio and Accident Victims

Rødovre Municipality, 2610, Denmark

Location

Related Publications (1)

• 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.

  PMID: 41287070 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tonny E Andersen, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Sophie L Ravn, PhD

  University of Southern Denmark

  STUDY DIRECTOR

• Anders O Aaby, PhD

  University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guest researcher

Model Details: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: February 17, 2025
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)