Spinal Cord Injury (SCI)VALIANTNCT06599632
Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Traumatic Spinal Cord Injury
A study testing Values-based Cognitive Behavioral Therapy (V-CBT) in people with Spinal Cord Injury (SCI), run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury (SCI)
- What is being tested?
- Values-based Cognitive Behavioral Therapy (V-CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Feb 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- willing to engage in homework
- willing to respond to daily questionnaires
- able to attend weekly sessions without payment
Who cannot join
- any red flags during physiotherapeutic examination
- acute or sub-acute stage
- current pressure ulcers
- known and unstable psychiatric disorder
- syringomyelia
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Specialized Hospital for Polio and Accident Victims
Rødovre Municipality, 2610
About this study
Official 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.
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)
- Being tested
- Values-based Cognitive Behavioral Therapy (V-CBT)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values-based Cognitive Behavioral Therapy (V-CBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
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
Measured: 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.
Measured: 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
Measured: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Feb 2025
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Orup Aaby, University of Southern Denmark
- Investigators
- Tonny E Andersen, PhD, Principal investigator, University of Southern DenmarkSophie L Ravn, PhD, Study director, University of Southern DenmarkAnders O Aaby, PhD, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599632
- Sponsor's protocol ID
- 2110041(SCI)
- Acronym
- VALIANT
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41287070
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06599632
- Acronym / sponsor ID
- VALIANT / 2110041(SCI)
- Conditions
- Spinal Cord Injury (SCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.
| Arm | Type | Receives |
|---|---|---|
| Baseline phase | Experimental | Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be 18 years or older
- speak and read Danish
- aquired spinal cord injury
- paraplegia or tetraplegia (either complete or incomplete)
- daily pain
Key exclusion criteria (6 listed)
- any red flags during physiotherapeutic examination
- acute or sub-acute stage
- current pressure ulcers
- known and unstable psychiatric disorder
- syringomyelia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Baseline phase |
Primary outcome
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.
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.
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.
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.
19 secondary outcomes
Pain catastrophizing
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Positive affect
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Negative affect
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Stress
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Fatigue
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain-related acceptance
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain-related self-efficacy
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain severity
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 41287070Aaby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonny E Andersen, PhD principal investigator
University of Southern Denmark
Sophie L Ravn, PhD study director
University of Southern Denmark
Anders O Aaby, PhD study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Values-based Cognitive Behavioral Therapy (V-CBT) in people with Spinal Cord Injury (SCI), run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value-based living (time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.