Value-based Cognitive Behavioral Therapy for Prevention of Chronic Whiplash-associated Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Value-based Cognitive Behavioural Therapy for the Prevention of Chronic Whiplash Associated Disorders: A Randomized Controlled Trial

Conditions
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Musculoskeletal Disorders, Whiplash

Intervention / Treatment
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* Behavioral: Value-based cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A receives value-based cognitive behavior therapy after randomization. | Behavioral: Value-based cognitive-behavioral therapy<br>* 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.<br>|
| Active Comparator: Group B<br>Group B receives value-based cognitive behavior therapy after 3 months. | Behavioral: Value-based cognitive-behavioral therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change scores at 12- and 24-weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | 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). | 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). | 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). | Change scores at 12- and 24-weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whiplash, prevention, pain, cognitive-behavioural therapy