None listed
Conditions
Brief summary
This study will use a single-case experimental design to investigate how pain-related outcomes and stress change during participation in the StressModex intervention for individuals with acute or sub-acute whiplash-associated disorders. Daily assessments of pain interference and stress (primary outcomes), along with pain intensity and pain bothersomeness (secondary outcomes), will be used to determine when changes occur across different phases of the intervention. Cross-lagged correlation analyses will be conducted on daily data to investigate whether stress operates as a mechanism of change in pain-related outcomes. Qualitative interviews will explore changes in pain-related beliefs, perceived pain controllability, and associated behavioural and emotional responses. The study will also evaluate whether stress, pain, neck disability, perceived recovery and related psychological factors improve from pre- to post-treatment and whether any observed improvements are maintained at six-month follow-up. The feasibility of using a wrist-based heart-rate monitor for daily HRV collection will also be assessed both qualitatively and quantitatively. Physiological stress, indexed by daily heart rate variability (HRV), will be examined to characterise its trajectory during treatment and assess its potential role as a mechanism underlying changes in pain-related outcomes.
Interventions
Name: StressModex • Description: Stress Modex is a structured, six-week, physiotherapist-delivered program integrating Stress Inoculation Training (SIT) with guideline-recommended physiotherapy exercise. The intervention combines education, skills training, and supervised exercise to support participants in recognising and managing stress and pain following acute or sub-acute whiplash-associated disorders. • Materials: Community physiotherapists receive in-person training from a member of the research team in the Stress Modex protocol and its delivery prior to treating participants. • Procedures: Participants attend one individual session per week for six weeks. Each session lasts approximately 60 minutes and introduces a new module of the Stress Modex intervention. Week 1 focuses on relaxed abdominal breathing. Week 2 introduces body scans, a mindfulness-based practice in which individuals systematically direct attention to different body parts, noticing sensations without judgment. Week 3 focuses on problem-solving techniques. Week 4 focuses on developing and practising adaptive coping self-statements. Week 5 emphasises practising SIT and coping skills in real-world stressful situations. Week 6 consolidates coping skills and focuses on maintaining gains over time. In all sessions, physiotherapists also instruct participants in guideline-recommended physiotherapy exercise, deemed appropriate based on the physiotherapist’s physical assessment of the participant. Physiotherapy assessment of each patient underpins the exercise prescription and progression. The physiotherapist will tailor the management program to the individual patient’s presentation and functional goals. Guideline-recommended exercises for WAD include neck-specific range of motion and strengthening exercises, and sensorimotor control exercises of the head and neck. Advice and prescription of functional activities and general aerobic and strengthening exercises can be included based on the patient’s prior activity levels and functional goals. Some patients may need to commence exercises at a low intensity, but others may commence at a higher intensity. Participants are encouraged to practise components of the intervention (e.g. relaxation, problem-solving, coping self-statements, and exercise) at least once per week at home between sessions to reinforce skills learned. • Who will deliver the intervention: community physiotherapists who have undergone training by the research team in the Stress Modex protocol will deliver the intervention. The StressModex protocol has been created by the research team. • Mode of delivery: The intervention is delivered individually, face-to-face. Participants are also encouraged to practise components of the intervention at home between sessions to reinforce skills learned. • Number of times and duration: Participants attend one session per week for six weeks, with each session lasting approximately 60 minutes. Participants are encouraged to practise the techniques introduced in each module at least once per week at home to consolidate learning. • Location: Participants will receive their intervention session in the physiotherapists clinic and then practice the skills learnt from a location of their choosing (e.g., at home). • Personalisation: The physiotherapy exercise component is tailored according to the physiotherapist’s physical assessment of each participant. The psychological skills components follow the structured sequence described above but may be discussed using examples relevant to the participant’s own stressors. •Adherence: Physiotherapists’ completion of all StressModex components within each session will be monitored and participant attendance at sessions will be recorded. Participants’ self-reported home practice will also be documented to provide an indication of adherence.
Sponsors
Study design
Eligibility
Inclusion criteria
(1) Whiplash associated disorder (WAD) grade two, less than 3 months post-injury, (2) medium to high risk of non-recovery, as determined by the WhipPredict prognostic tool. (3) not actively receiving psychological or medical treatment for WAD at the time of enrolment (excluding medications), (4) aged over 18 years and proficient written and spoken English, (5) access to the internet on a computer or smartphone, (6) ability and willingness to physically attend the physiotherapy clinic during the six week intervention period.
Exclusion criteria
(1) known or suspected serious spinal pathology (e.g., metastatic disease of the spine), (2) fracture or injury in other body areas as a result of the traffic accident, (3) cervical spinal surgery in the past 12 months, (4) medical or dermatological condition that prevents the safe and comfortable wear of a wrist-based heart rate monitor (e.g., severe skin sensitivity, open wounds, or musculoskeletal impairments affecting the wrist), (5) meeting the criteria for probable acute stress disorder diagnosis on the Acute Stress Disorder Scale (ASDS) (6) active malignancy (e.g., cancer not in remission), terminal illnesses, serious medical conditions that could interfere with trial participation or limit potential treatment benefits (e.g., lupus, self-report diagnosis of primary psychotic disorder, major thought disorder, or other unstable/severe psychiatric or behavioural conditions).