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

NCT ID: NCT06386068

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2024-09-17

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 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.

Conditions

Whiplash Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baseline phase

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.

Group Type: EXPERIMENTAL

Values-based Cognitive Behavioral Therapy (V-CBT)

Intervention Type: 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.

Interventions

Values-based Cognitive Behavioral Therapy (V-CBT)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Tonny Elmose Andersen, phd.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tonny E Andersen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Sophie L Ravn, PhD

Role: STUDY_DIRECTOR

University of Southern Denmark

Anders O Aaby, PhD

Role: STUDY_DIRECTOR

Specialized Hospital for Polio and Accident Victims

Locations

Specialized Hospital for Polio and Accident Victims

Rødovre Municipality, Capital Region of Denmark, Denmark

Countries

Denmark

Other Identifiers

2110041

Identifier Type: -

Identifier Source: org_study_id