Clinical trial NCT02251028: Value-based Cognitive Behavioral Therapy for Prevention of Chronic Whiplash-associated Disorders
Official title: Value-based Cognitive Behavioural Therapy for the Prevention of Chronic Whiplash Associated Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Whiplash
Keywords: whiplash, prevention, pain, cognitive-behavioural therapy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Disability as measured by Pain Disability Index
timeFrame: Change scores at 12- and 24-weeks after randomization
Secondary outcomes:
measure: Pain by NDI
timeFrame: Change scores at 12- and 24-weeks after randomization
measure: Pain by NRS
timeFrame: Change scores at 12- and 24-weeks after randomization
measure: Fear of re-injury by TSK
timeFrame: Change scores at 12- and 24-weeks after randomization
measure: Pain-related catastrophizing by PCS
timeFrame: Change scores at 12- and 24-weeks after randomization
measure: Anxiety and depression by HADS
timeFrame: Change scores at 12- and 24-weeks after randomization
measure: PTSD-symptomatology
timeFrame: Change scores at 12- and 24-weeks after randomization
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Syddanmark
Study officials:
affiliation: Department of Psychology
name: Tonny Elmose Andersen, MSc,Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Psychology
name: Ask Elklit, professor
role: STUDY_DIRECTOR
References:
citation: 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.