NCT02251028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

5.8 years

First QC Date

September 19, 2014

Last Update Submit

November 9, 2020

Conditions

Musculoskeletal DisordersWhiplash

Keywords

whiplash, prevention, pain, cognitive-behavioural therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Pain by NDI

    Change scores at 12- and 24-weeks after randomization

  • Pain by NRS

    Change scores at 12- and 24-weeks after randomization

  • Fear of re-injury by TSK

    Change scores at 12- and 24-weeks after randomization

  • Pain-related catastrophizing by PCS

    Change scores at 12- and 24-weeks after randomization

  • Anxiety and depression by HADS

    Change scores at 12- and 24-weeks after randomization

  • +1 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A receives value-based cognitive behavior therapy after randomization.

Behavioral: Value-based cognitive-behavioral therapy

Group B

ACTIVE COMPARATOR

Group B receives value-based cognitive behavior therapy after 3 months.

Behavioral: Value-based cognitive-behavioral therapy

Interventions

Value-based cognitive-behavioral therapyBEHAVIORAL

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.

Group AGroup B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Region Syddanmark, 5230, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26323830DERIVED

MeSH Terms

Conditions

Musculoskeletal DiseasesWhiplash InjuriesPain

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tonny Elmose Andersen, MSc,Ph.D.

    Department of Psychology

    STUDY DIRECTOR

  • Ask Elklit, professor

    Department of Psychology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc., Ph.D

Study Record Dates

First Submitted

September 19, 2014

First Posted

September 26, 2014

Study Start

January 1, 2013

Primary Completion

October 1, 2018

Study Completion

December 1, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)