Whiplash InjuriesVALIANTNCT06386068

Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Persistent Whiplash Associated Disorders.

A study testing Values-based Cognitive Behavioral Therapy (V-CBT) in people with Whiplash Injuries, run by University of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 persistent whiplash. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Whiplash Injuries
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: 12 participants
Where: 1 siteDenmark
Study dates: 23 Jan 2024to 17 Sep 2024
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

have persistent symptoms after a whiplash injury that happened more than 3 months ago
have pain and disability defined as > 35 % on Neck Disability Index (NDI)
be 18 years or older
speak and read Danish

Who cannot join

denote headache as the primary problem
show red flags in the neurological and physiotherapeutic examination such as known or suspected serious spinal pathology, confirmed fracture or dislocation in the neck at the time of injury or signs of nerve root compromise (weakness, reflex changes or sensory loss)
have had spinal surgery within the past 12 months
are socially and occupationally unresolved
have daily significant functional limitations related to other pain conditions
have severe psychiatric illness
are pregnant
are not willing or able to respond to items on a daily basis.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Specialized Hospital for Polio and Accident Victims
Rødovre Municipality, Capital Region of Denmark, 2610

Other trials in Denmark

About this study

Official title: Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Persistent Whiplash Associated Disorders After Road Traffic Accidents: Protocol for a Multiple Baselines Single-case Experimental Design.

What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?
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). Twelve 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 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: Whiplash Injuries
Being tested: Values-based Cognitive Behavioral Therapy (V-CBT)
Medical subject headings: Whiplash 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 chronic Whiplash-Associated Disorder (WAD). 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 groups in NCT06386068
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 (20)

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).
Neck Disability
Neck Disability Index. 10 item scale. Scored on a scale from 0 to 5. 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
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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 202417 Sep 2024

First posted26 Apr 2024
Study start23 Jan 2024
Primary completion17 Sep 2024
Study completion17 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Whiplash InjuriesStudies 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06386068
Sponsor's protocol ID: 2110041
Acronym: VALIANT
Status last verified: Aug 2024
First submitted: 26 Jan 2024
Last updated: 2 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Recruiting
Virtual Reality Rehabilitation in Neck Pain Subjects
Neck Pain, Chronic Pain
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries

All Whiplash Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Persistent Whiplash Associated Disorders After Road Traffic Accidents: Protocol for a Multiple Baselines Single-case Experimental Design.
ClinicalTrials.gov ID: NCT06386068
Acronym / sponsor ID: VALIANT / 2110041
Conditions: Whiplash Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of Southern DenmarkUniversity, hospital or other
Study start: 23 Jan 2024 (actual)
Primary completion: 17 Sep 2024 (actual)
Study completion: 17 Sep 2024 (actual)
First posted: 26 Apr 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.

What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?
What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?

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 (4 listed)

have persistent symptoms after a whiplash injury that happened more than 3 months ago
have pain and disability defined as > 35 % on Neck Disability Index (NDI)
be 18 years or older
speak and read Danish

Key exclusion criteria (8 listed)

denote headache as the primary problem
show red flags in the neurological and physiotherapeutic examination such as known or suspected serious spinal pathology, confirmed fracture or dislocation in the neck at the time of injury or signs of nerve root compromise (weakness, reflex changes or sensory loss)
have had spinal surgery within the past 12 months
are socially and occupationally unresolved
have daily significant functional limitations related to other pain conditions

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 chronic Whiplash-Associated Disorder (WAD). 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.

20 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).
Neck 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
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

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 2 Oct 2024.
Individual participant dataSharing planned: No

Related trials for Whiplash Injuries

Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Recruiting
Virtual Reality Rehabilitation in Neck Pain Subjects
Neck Pain, Chronic Pain
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries

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

Specialized Hospital for Polio and Accident Victims

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 Whiplash Injuries, 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 4 inclusion and 8 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 2 Oct 2024. 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 NCT06386068.

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 2 Oct 2024.