Musculoskeletal DisordersNCT02251028
Value-based Cognitive Behavioral Therapy for Prevention of Chronic Whiplash-associated Disorders
A study testing Value-based cognitive-behavioral therapy in people with Musculoskeletal Disorders and Whiplash, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether a specifically tailored value-based cognitive behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Disorders, Whiplash
- What is being tested?
- Value-based cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Dec 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 18 and 65-years-old
- WAD level I-II.
- 3-months post-injury
- Disability in at least one important life domain (≥ 5 on the pain disability index) and moderate levels of pain (average pain intensity ≥ 4 on the NRS scale).
- Meet at least one of the psychological risk criteria:
- Elevated levels of pain catastrophizing, fear-avoidance-beliefs, symptoms of anxiety and/or depression, and posttraumatic stress symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value-based Cognitive Behavioural Therapy for the Prevention of Chronic Whiplash Associated Disorders: A Randomized Controlled Trial
The purpose of this study is to determine whether a specifically tailored value-based cognitive behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury.
Read the detailed description
The primary objective of the present study is to test whether a specifically tailored value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. Methods. The current study is a two-armed randomized controlled study with a crossover design. Group A is scheduled for V-CBT within one week of randomization and group B with a delayed onset 3 months after randomization.
- Conditions
- Musculoskeletal Disorders, Whiplash
- Being tested
- Value-based cognitive-behavioral therapy
- Keywords
- whiplash, prevention, pain, cognitive-behavioural therapy
- Medical subject headings
- Musculoskeletal Diseases, Whiplash Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Value-based cognitive-behavioral therapyBehavioural
The intervention is a manualized program specifically tailored for prevention of disability and psychological distress after whiplash injuries. The intervention is delivered by two trained clinical psychologists og consists of 10 weekly one-hour individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A receives value-based cognitive behavior therapy after randomization. Receives: Behavioral: Value-based cognitive-behavioral therapy |
| Group B | Active comparator | Group B receives value-based cognitive behavior therapy after 3 months. Receives: Behavioral: Value-based cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability as measured by Pain Disability Index
The PDI measures how pain interferes with daily life activities within 7 different domains. The 7 domains are rated from 0 (no disability) to 10 (worst disability). The scale shows good reliability and validity.
Measured: Change scores at 12- and 24-weeks after randomization
Secondary outcomes (6)
Pain by NDI
Neck pain intensity and disability is measured with the Neck Disability Index (NDI; Vernon \& Mior, 1991). The NDI measures within 10 domains pain and how neck pain affects the ability to handle daily life activities such as personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration, and headache. The total score range from 0 (no disability) to 100 (total disability).
Measured: Change scores at 12- and 24-weeks after randomization
Pain by NRS
Pain is also measured on four numerical pain rating scales (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Patients mark their answers on each scale corresponding to their pain now, highest level of pain, lowest level of pain, and finally average pain over the past week (NRS: Turk \& Melzack, 2001).
Measured: Change scores at 12- and 24-weeks after randomization
Fear of re-injury by TSK
Fear of re-injury due to movement is measured with Tampa Scale for Kinesiophobia (TSK; Kori, Miller, \& Todd, 1990). TSK is a 17-item scale assessing fear of movement on a 4-point likert scale ranging from 17 to 68 with higher scores indicating higher levels of kinesiophobia. The scale is commonly used in various chronic pain samples and has good construct and predictive validity (Roelofs, Goubert, Peters, Vlayen, \& Crombes, 2004). The clinical cut-off score is set to ≥ 37.
Measured: Change scores at 12- and 24-weeks after randomization
Pain-related catastrophizing by PCS
Catastrophic thinking related to pain is measured with the Pain Catastrophizing Scale (PCS; Sullivan, Bishop, Pivik, 1995). The PCS-instructions ask participants to reflect on past painful experiences and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain on a five-point Likert scale with (0 = not at all, 4 = all the time).
Measured: Change scores at 12- and 24-weeks after randomization
Anxiety and depression by HADS
To assess the level of anxiety and depressive symptoms, the Hospital Anxiety and Depression Scale is used (HADS; Zigmond \& Snaith, 1983). The scale consists of 14 items, 7 relating to anxiety (HADS-A) and 7 to depression (HADS-D) with responses ranging from 0 (no symptoms) to 3 (maximum impairment). A cut-off score of ≥ 8 on each subscale is used in order to include all possible cases of depression and anxiety as suggested by (Zigmond \& Snaith, 1983).
Measured: Change scores at 12- and 24-weeks after randomization
PTSD-symptomatology
PTSD-symptomatology is measured with the PTSD-8 (Hansen, Andersen, Armour, Elklit, Palic, \& Mackrill, 2010). The scale is a brief version of The Harvard Trauma Questionnaire part IV (HTQ-IV; Molicca, Caspi-Yavin, Bollini, \& Truong, 1992) and consists of 8 items on a four-point Likert scale (1 = not at all, 4 = very often). The items relate to the three core clusters in PTSD in DSM-IV: avoidance (2 items), intrusion (4 items), and hyperarousal (2 items). The scale has proven good psychometric properties in various trauma samples including whiplash injured (Hansen et al., 2010).
Measured: Change scores at 12- and 24-weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2018
- Study completionDec 2019
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 Musculoskeletal DisordersStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonny Elmose Andersen, phd., University of Southern Denmark
- Investigators
- Tonny Elmose Andersen, MSc,Ph.D., Study director, Department of PsychologyAsk Elklit, professor, Study director, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251028
- Sponsor's protocol ID
- S-20130103
- Status last verified
- Nov 2020
- First submitted
- 19 Sep 2014
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Andersen TE, Ravn SL, Roessler KK. Value-based cognitive-behavioural therapy for the prevention of chronic whiplash associated disorders: protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2015 Sep 1;16:232. doi: 10.1186/s12891-015-0687-y.
PubMed 26323830
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value-based Cognitive Behavioural Therapy for the Prevention of Chronic Whiplash Associated Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02251028
- Acronym / sponsor ID
- S-20130103
- Conditions
- Musculoskeletal Disorders, Whiplash
- Keywords
- whiplash, prevention, pain, cognitive-behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 26 Sep 2014 (estimated)
- 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 purpose of this study is to determine whether a specifically tailored value-based cognitive behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury.
Detailed description
The primary objective of the present study is to test whether a specifically tailored value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. Methods. The current study is a two-armed randomized controlled study with a crossover design. Group A is scheduled for V-CBT within one week of randomization and group B with a delayed onset 3 months after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Value-based cognitive-behavioral therapyGroup A receives value-based cognitive behavior therapy after randomization. |
| Group B | Active comparator | Behavioral: Value-based cognitive-behavioral therapyGroup B receives value-based cognitive behavior therapy after 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Value-based cognitive-behavioral therapyThe intervention is a manualized program specifically tailored for prevention of disability and psychological distress after whiplash injuries. The intervention is delivered by two trained clinical psychologists og consists of 10 weekly one-hour individual sessions. | Behavioural | Group A, Group B |
Primary outcome
Disability as measured by Pain Disability Index
Time frame: Change scores at 12- and 24-weeks after randomization
The PDI measures how pain interferes with daily life activities within 7 different domains. The 7 domains are rated from 0 (no disability) to 10 (worst disability). The scale shows good reliability and validity.
6 secondary outcomes
Pain by NDI
Time frame: Change scores at 12- and 24-weeks after randomization
Pain by NRS
Time frame: Change scores at 12- and 24-weeks after randomization
Fear of re-injury by TSK
Time frame: Change scores at 12- and 24-weeks after randomization
Pain-related catastrophizing by PCS
Time frame: Change scores at 12- and 24-weeks after randomization
Anxiety and depression by HADS
Time frame: Change scores at 12- and 24-weeks after randomization
PTSD-symptomatology
Time frame: Change scores at 12- and 24-weeks after randomization
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 10 Nov 2020.
- Derived from this study: PubMed 26323830Andersen TE, Ravn SL, Roessler KK. Value-based cognitive-behavioural therapy for the prevention of chronic whiplash associated disorders: protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2015 Sep 1;16:232. doi: 10.1186/s12891-015-0687-y.
- 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 Elmose Andersen, MSc,Ph.D. study director
Department of Psychology
Ask Elklit, professor study director
Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Value-based cognitive-behavioral therapy in people with Musculoskeletal Disorders and Whiplash, 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?
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 10 Nov 2020. 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?
Disability as measured by Pain Disability Index (time frame: Change scores at 12- and 24-weeks after randomization). 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 NCT02251028, 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 10 Nov 2020.