protocolSection identificationModule nctId: NCT06386068, orgStudyIdInfo id: 2110041, briefTitle: Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Persistent Whiplash Associated Disorders., acronym: VALIANT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Whiplash Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Values-based Cognitive Behavioral Therapy (V-CBT), outcomesModule primaryOutcomes measure: Value-based living, primaryOutcomes measure: Pain interference, primaryOutcomes measure: Value-based living, primaryOutcomes measure: Pain interference, secondaryOutcomes measure: Pain catastrophizing, secondaryOutcomes measure: Positive affect, secondaryOutcomes measure: Negative affect, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Pain-related acceptance, secondaryOutcomes measure: Pain-related self-efficacy, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Neck Disability, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Pain-related acceptance, secondaryOutcomes measure: Pain-related self-efficacy, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Self-perceived improvement, secondaryOutcomes measure: Satisfaction with treatment, secondaryOutcomes measure: Pain Disability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Specialized Hospital for Polio and Accident Victims, status: RECRUITING, city: Rødovre, state: Capital Region Of Denmark, zip: 2610, country: Denmark, contacts name: Anders O Aaby, PhD, role: CONTACT, email: aaa@specialhospitalet.dk, geoPoint lat: 55.68062, lon: 12.45373, hasResults: False