The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are: * What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash? * What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program? Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The intervention offers a 10-session treatment for chronic Whiplash-Associated Disorder (WAD). The manualized adapted version of value-based cognitive behavioral treatment (V-CBT) is conducted by interdisciplinary teams of psychologists and physiotherapists. The program, based on V-CBT principles, focuses on psychoeducation, fostering self-efficacy, and setting value-based goals in the initial three sessions. The subsequent seven sessions involve physiotherapists trained in V-CBT, addressing psychological, physical, social, and practical barriers hindering engagement in participants' lives. Each session combines psychologically informed themes and supervised exercises, aiming to enhance engagement in values-based activities.
Specialized Hospital for Polio and Accident Victims
Rødovre Municipality, Capital Region of Denmark, Denmark
Value-based living
Single item measure based on Engaged Living Scale. Scored on a scale from 0 to 10. Higher scores means greater levels of value-based living.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain interference
Three single items focused specifically on general activities, relations with other people, and sleep. Based on Brief Pain Inventory. All three are scored on a scale from 0 to 10. Higher scores means greater levels of pain interference.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Value-based living
Engaged Living Scale. 16 item scale. Scored on a scale from 1 to 5. Higher total scores indicate greater levels of value-based living.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain interference
Brief Pain Inventory. 7 item scale. Scored on a scale from 0 to 10. Higher total scores indicate greater pain interference.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain catastrophizing
Single item measure based on Daily Pain Catastrophizing Scale). Scored on a scale from 0 to 10. Higher scores means greater levels of pain catastrophizing.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Positive affect
Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of positive affect.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Negative affect
Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of negative affect.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Stress
Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of stress.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Fatigue
Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of fatigue.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain-related acceptance
Single item measure based on Chronic Pain Acceptance Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of acceptance.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain-related self-efficacy
Single item measure based on Pain Self-efficacy Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of self-efficacy.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Pain severity
Single item measure based on Brief Pain Inventory. Scored on a scale from 0 to 10. Higher scores means greater levels of pain severity.
Time frame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
Neck Disability
Neck Disability Index. 10 item scale. Scored on a scale from 0 to 5. Higher total scores indicate greater disability.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Depression
Patient Health Questionnaire (PHQ-9). 9 item scale. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of depression.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Anxiety
Generalized Anxiety Disorder (GAD-7). 7 items. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of anxiety.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Stress
Perceived Stress Scale. 10 items. Scored on a 5-point scale. Higher total scores indicate greater levels of stress.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Health-related quality of life
EuroQoL-5D-5L. 5 items scored on a 5-point scale and one item scored on a 0 to 100 scale. Higher scores on the first 5 items indicate reduced quality of life and higher scores on the last item indicates greater quality of life.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain-related acceptance
Chronic Pain Acceptance Questionnaire (CPAQ-8). 8 items scored on a scale from 0 to 6. Higher total scores indicate greater levels of acceptance.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain-related self-efficacy
Pain Self-Efficacy Questionnaire. 2 items scored on a scale from 0 to 6. Higher scores indicate greater self-efficacy.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Sleep quality
Karolinska Sleep Questionnaire. 4 items scores on a scale from 0 to 5. Higher total scores indicates poorer quality of sleep.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain severity
Four 0-10 numeric rating scale (NRS) for worst, mildest, average, and current pain. Scored on a scale from 0 to 10. Higher scores indicate greater levels of pain severity.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Self-perceived improvement
Global Rating of Change. 1 item scored on a scale from 1 to 15. Higher scores indicate greater level of self-perceived improvement.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Satisfaction with treatment
Self-developed NRS-item from 0 = not at all satisfied to 10 = completely satisfied.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Pain Disability
Pain Disability Index. 7 items scored on a scale from 0 to 10. Higher total scores indicate greater disability.
Time frame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
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