Interdisciplinary Value-based Cognitive Behavioral Treatment for People with Persistent Whiplash Associated Disorders. (VALIANT)

University of Southern Denmark (SDU)

Status: Completed

Conditions: Whiplash Injuries

Treatments: Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06386068

2110041

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have persistent symptoms after a whiplash injury that happened more than 3 months ago
• have pain and disability defined as > 35 % on Neck Disability Index (NDI)
• be 18 years or older
• speak and read Danish

Exclusion criteria

• denote headache as the primary problem
• show red flags in the neurological and physiotherapeutic examination such as known or suspected serious spinal pathology, confirmed fracture or dislocation in the neck at the time of injury or signs of nerve root compromise (weakness, reflex changes or sensory loss)
• have had spinal surgery within the past 12 months
• are socially and occupationally unresolved
• have daily significant functional limitations related to other pain conditions
• have severe psychiatric illness
• are pregnant
• are not willing or able to respond to items on a daily basis.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Baseline phase

Experimental group

Description:

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.

Treatment:

Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)