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

NCT06386068 | Completed DMC

• 1 other identifier: 2110041
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Value-based living

  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.

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Pain interference

  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.

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Value-based living

  Engaged Living Scale. 16 item scale. Scored on a scale from 1 to 5. Higher total scores indicate greater levels of 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

• Pain interference

  Brief Pain Inventory. 7 item scale. Scored on a scale from 0 to 10. Higher total scores indicate greater pain interference.

  Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion

Secondary Outcomes (20)

• Pain catastrophizing

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Positive affect

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Negative affect

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Stress

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

• Fatigue

  Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).

Study Arms (1)

Baseline phase

EXPERIMENTAL

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.

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

Interventions

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

Baseline phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Specialized Hospital for Polio and Accident Victims

Rødovre Municipality, Capital Region of Denmark, 2610, Denmark

Location

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries

Study Officials

• Tonny E Andersen, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Sophie L Ravn, PhD

  University of Southern Denmark

  STUDY DIRECTOR

• Anders O Aaby, PhD

  Specialized Hospital for Polio and Accident Victims

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: April 26, 2024
• Study Start: January 23, 2024
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)