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

November 9, 2020 updated by: Tonny Elmose Andersen, phd., University of Southern Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Syddanmark
      • Odense, Syddanmark, Denmark, 5230
        • University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Study Director: Tonny Elmose Andersen, MSc,Ph.D., Department of Psychology
  • Study Director: Ask Elklit, professor, Department of Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20130103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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