An interventional study of Value-based cognitive-behavioral therapy in Musculoskeletal Disorders and Whiplash, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Prevention
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.
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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 92 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
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Group A receives value-based cognitive behavior therapy after randomization.
Behavioral: Value-based cognitive-behavioral therapy
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.
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.
Time frame: Change scores at 12- and 24-weeks after randomization
Pain by NDI
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).
Time frame: Change scores at 12- and 24-weeks after randomization
Pain by NRS
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).
Time frame: Change scores at 12- and 24-weeks after randomization
Fear of re-injury by TSK
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.
Time frame: Change scores at 12- and 24-weeks after randomization
Pain-related catastrophizing by PCS
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).
Time frame: Change scores at 12- and 24-weeks after randomization
Anxiety and depression by HADS
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).
Time frame: Change scores at 12- and 24-weeks after randomization
PTSD-symptomatology
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).
Time frame: Change scores at 12- and 24-weeks after randomization
Plan to share: No
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University of Southern Denmark