Spinal Cord Injury (SCI)
Conditions
Brief summary
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 spinal cord injury. 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 spinal cord injury? * 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). Nine 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 either in person at Specialized Hospital for Polio and Accident Victims or virtually via secure videoconferencing 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.
Interventions
The intervention offers a 10-session treatment for spinal cord injury (SCI). 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.
Sponsors
University of Southern Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be 18 years or older * speak and read Danish * aquired spinal cord injury * paraplegia or tetraplegia (either complete or incomplete) * daily pain * therapy-ready and motivated for this treatment type * willing to engage in homework * willing to respond to daily questionnaires * able to attend weekly sessions without payment
Exclusion criteria
* any red flags during physiotherapeutic examination * acute or sub-acute stage * current pressure ulcers * known and unstable psychiatric disorder * syringomyelia * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Value-based living | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | 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. |
| Pain interference | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative affect | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of negative affect. |
| Stress | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of stress. |
| Fatigue | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of fatigue. |
| Pain-related acceptance | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | Single item measure based on Chronic Pain Acceptance Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of acceptance. |
| Pain-related self-efficacy | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | 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 |
| Pain severity | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | Single item measure based on Brief Pain Inventory. Scored on a scale from 0 to 10. Higher scores means greater levels of pain severity. |
| Pain catastrophizing | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | 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. |
| Depression | Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion | Patient Health Questionnaire (PHQ-9). 9 item scale. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of depression. |
| Anxiety | Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion | Generalized Anxiety Disorder (GAD-7). 7 items. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of anxiety. |
| Health-related 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 | 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. |
| Sleep quality | Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion | Karolinska Sleep Questionnaire. 4 items scores on a scale from 0 to 5. Higher total scores indicates poorer quality of sleep. |
| 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 | Global Rating of Change. 1 item scored on a scale from 1 to 15. Higher scores indicate greater level of self-perceived improvement. |
| Satisfaction with treatment | Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion | Self-developed NRS-item from 0 = not at all satisfied to 10 = completely satisfied. |
| Pain Disability | Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion | Pain Disability Index. 7 items scored on a scale from 0 to 10. Higher total scores indicate greater disability |
| Positive affect | Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks). | Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of positive affect. |
Countries
Denmark
Outcome results
None listed