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

Not Applicable

Completed

• Conditions: Musculoskeletal Disorders; Whiplash

• Registration Number: NCT02251028
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Primary Completion: 2018-10
• Study Completion: 2019-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Disability as measured by Pain Disability Index	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

Name	Time	Method
Pain by NDI	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).
Pain by NRS	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).
Fear of re-injury by TSK	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.
PTSD-symptomatology	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).
Pain-related catastrophizing by PCS	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).
Anxiety and depression by HADS	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).

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Syddanmark, Denmark