Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Spinal Cord Injury (VALIANT)
- Conditions
- Spinal Cord Injury (SCI)
- Interventions
- Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)
- Registration Number
- NCT06599632
- Lead Sponsor
- University of Southern Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
- 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
- any red flags during physiotherapeutic examination
- acute or sub-acute stage
- current pressure ulcers
- known and unstable psychiatric disorder
- syringomyelia
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Baseline phase Values-based Cognitive Behavioral Therapy (V-CBT) 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.
- Primary Outcome Measures
Name Time Method 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 Engaged Living Scale. 16 item scale. Scored on a scale from 1 to 5. Higher total scores indicate greater levels of value-based living.
Pain interference Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion Brief Pain Inventory. 7 item scale. Scored on a scale from 0 to 10. Higher total scores indicate greater pain interference.
- Secondary Outcome Measures
Name Time Method 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.
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.
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 Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion Perceived Stress Scale. 10 items. Scored on a 5-point scale. Higher total scores indicate 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 Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion Chronic Pain Acceptance Questionnaire (CPAQ-8). 8 items scored on a scale from 0 to 6. Higher total scores indicate greater levels of acceptance.
Pain-related self-efficacy Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion Pain Self-Efficacy Questionnaire. 2 items scored on a scale from 0 to 6. Higher scores indicate greater self-efficacy.
Pain severity Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion 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
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
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.
Trial Locations
- Locations (1)
Specialized Hospital for Polio and Accident Victims
🇩🇰Roedovre, Denmark