MedDataX Logo

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

NCT ID: NCT02251028

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Disorders Whiplash

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

whiplash, prevention, pain, cognitive-behavioural therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

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

Group Type ACTIVE_COMPARATOR

Value-based cognitive-behavioral therapy

Intervention Type BEHAVIORAL

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 B

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

Group Type ACTIVE_COMPARATOR

Value-based cognitive-behavioral therapy

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tonny Elmose Andersen, phd.

MSc., Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tonny Elmose Andersen, MSc,Ph.D.

Role: STUDY_DIRECTOR

Department of Psychology

Ask Elklit, professor

Role: STUDY_DIRECTOR

Department of Psychology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Southern Denmark

Odense, Region Syddanmark, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26323830 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S-20130103

Identifier Type: -

Identifier Source: org_study_id