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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline phase | Experimental | There are three baseline phases of 1, 2, or 3 weeks to which participants are block-randomized followed by a 10-week intervention phase. Hence, participants are their own case-controls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Values-based Cognitive Behavioral Therapy (V-CBT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). |
| Positive affect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonny E Andersen, PhD | University of Southern Denmark | Principal Investigator |
| Sophie L Ravn, PhD | University of Southern Denmark | Study Director |
| Anders O Aaby, PhD | Specialized Hospital for Polio and Accident Victims | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialized Hospital for Polio and Accident Victims | Rødovre Municipality | Capital Region of Denmark | 2610 | Denmark |
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| ID | Term |
|---|---|
| D014911 | Whiplash Injuries |
| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| D014947 | Wounds and Injuries |
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A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.
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Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of positive affect. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion |