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

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ClinicalTrials.gov Identifier: NCT02251028
Recruitment Status : Unknown
Verified November 2016 by Tonny Elmose Andersen, phd., University of Southern Denmark.
Recruitment status was:  Recruiting
First Posted : September 26, 2014
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Tonny Elmose Andersen, phd., University of Southern Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Disorders Whiplash Behavioral: Value-based cognitive-behavioral therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Value-based Cognitive Behavioural Therapy for the Prevention of Chronic Whiplash Associated Disorders: A Randomized Controlled Trial
Study Start Date : January 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Group A
Group A receives value-based cognitive behavior therapy after randomization.
Behavioral: Value-based cognitive-behavioral therapy
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.

Active Comparator: Group B
Group B receives value-based cognitive behavior therapy after 3 months.
Behavioral: Value-based cognitive-behavioral therapy
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain by NDI [ Time Frame: Change scores at 12- and 24-weeks after randomization ]
    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).

  2. Pain by NRS [ Time Frame: Change scores at 12- and 24-weeks after randomization ]
    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).

  3. Fear of re-injury by TSK [ Time Frame: Change scores at 12- and 24-weeks after randomization ]
    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.

  4. Pain-related catastrophizing by PCS [ Time Frame: Change scores at 12- and 24-weeks after randomization ]
    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).

  5. Anxiety and depression by HADS [ Time Frame: Change scores at 12- and 24-weeks after randomization ]
    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).

  6. PTSD-symptomatology [ Time Frame: Change scores at 12- and 24-weeks after randomization ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251028


Contacts
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Contact: Tonny Elmose Andersen, MCs,Ph.D. +45 20612003 tandersen@health.sdu.dk

Locations
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Denmark
University of Southern Denmark Recruiting
Odense, Syddanmark, Denmark, 5230
Contact: Tonny Andersen, Msc, phd.    004520612003    tandersen@health.sdu.dk   
Contact: Ask Elklit, professor    004520612003    aelklit@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
Investigators
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Study Director: Tonny Elmose Andersen, MSc,Ph.D. Department of Psychology
Study Director: Ask Elklit, professor Department of Psychology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tonny Elmose Andersen, phd., MSc., Ph.D, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02251028     History of Changes
Other Study ID Numbers: S-20130103
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tonny Elmose Andersen, phd., University of Southern Denmark:
whiplash, prevention, pain, cognitive-behavioural therapy
Additional relevant MeSH terms:
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Disease
Whiplash Injuries
Musculoskeletal Diseases
Pathologic Processes
Neck Injuries
Wounds and Injuries