Clinical trial NCT06599632: Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Traumatic Spinal Cord Injury
Official title: Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Spinal Cord Injury After Road Traffic Accidents: Protocol for a Multiple Baselines Single-case Experimental Design.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury (SCI)
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Value-based living
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Pain interference
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Value-based living
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Pain interference
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Secondary outcomes:
measure: Pain catastrophizing
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Positive affect
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Negative affect
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Stress
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Fatigue
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Pain-related acceptance
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Pain-related self-efficacy
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Pain severity
timeFrame: Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).
measure: Pain Disability
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Depression
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Anxiety
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Stress
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Health-related quality of life
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Pain-related acceptance
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Pain-related self-efficacy
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Sleep quality
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Pain severity
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Self-perceived improvement
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
measure: Satisfaction with treatment
timeFrame: Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion
Other outcomes:
Locations:
city: Rødovre
country: Denmark
facility: Specialized Hospital for Polio and Accident Victims
Study officials:
affiliation: University of Southern Denmark
name: Tonny E Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Sophie L Ravn, PhD
role: STUDY_DIRECTOR
affiliation: University of Southern Denmark
name: Anders O Aaby, PhD
role: STUDY_DIRECTOR
References: