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Completed

NCT Number: NCT06599632

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

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.

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Key information

Conditions

Spinal Cord Injury (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Specialized Hospital for Polio and Accident Victims

Rødovre Municipality, 2610, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Value-based living

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

    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.

  2. Pain interference

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

    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.

  3. Value-based living

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Engaged Living Scale. 16 item scale. Scored on a scale from 1 to 5. Higher total scores indicate greater levels of value-based living.

  4. Pain interference

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Brief Pain Inventory. 7 item scale. Scored on a scale from 0 to 10. Higher total scores indicate greater pain interference.

Secondary outcomes

  1. Pain catastrophizing

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

    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.

  2. Positive affect

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

    Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of positive affect.

  3. Negative affect

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

    Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of negative affect.

  4. Stress

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

    Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of stress.

  5. Fatigue

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

    Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of fatigue.

  6. Pain-related acceptance

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

    Single item measure based on Chronic Pain Acceptance Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of acceptance.

  7. Pain-related self-efficacy

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

    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

  8. Pain severity

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

    Single item measure based on Brief Pain Inventory. Scored on a scale from 0 to 10. Higher scores means greater levels of pain severity.

  9. Pain Disability

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Pain Disability Index. 7 items scored on a scale from 0 to 10. Higher total scores indicate greater disability

  10. Depression

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Patient Health Questionnaire (PHQ-9). 9 item scale. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of depression.

  11. Anxiety

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Generalized Anxiety Disorder (GAD-7). 7 items. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of anxiety.

  12. Stress

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Perceived Stress Scale. 10 items. Scored on a 5-point scale. Higher total scores indicate greater levels of stress.

  13. Health-related quality of life

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    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.

  14. Pain-related acceptance

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Chronic Pain Acceptance Questionnaire (CPAQ-8). 8 items scored on a scale from 0 to 6. Higher total scores indicate greater levels of acceptance.

  15. Pain-related self-efficacy

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Pain Self-Efficacy Questionnaire. 2 items scored on a scale from 0 to 6. Higher scores indicate greater self-efficacy.

  16. Sleep quality

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Karolinska Sleep Questionnaire. 4 items scores on a scale from 0 to 5. Higher total scores indicates poorer quality of sleep.

  17. Pain severity

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    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

  18. Self-perceived improvement

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Global Rating of Change. 1 item scored on a scale from 1 to 15. Higher scores indicate greater level of self-perceived improvement.

  19. Satisfaction with treatment

    Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

    Self-developed NRS-item from 0 = not at all satisfied to 10 = completely satisfied.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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.

Acronym: VALIANT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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