An interventional study of StressModex plus Treatment as Usual in Post-Traumatic Neck Pain and Whiplash-associated Disorders, sponsored by University of Southern Denmark. Not yet recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Other
Post-traumatic neck pain is a common consequence of traffic-related and other accidental injuries. While many individuals recover, a subgroup develops persistent pain, disability, and psychological distress. Building on previous adaptation and feasibility work, this randomised pilot trial will assess the feasibility of conducting a future definitive randomised controlled trial comparing StressModex plus treatment as usual (TAU) with TAU alone in individuals at risk of persistent post-traumatic neck pain.
The primary feasibility objectives are to assess recruitment using a revised multi-source recruitment strategy and participant retention and remote outcome data collection. Secondary feasibility objectives are to assess the feasibility and acceptability of randomisation, characterise TAU and concurrent healthcare use, and estimate parameters relevant to the sample size calculation for a future definitive RCT. Intervention fidelity, adherence, acceptability, safety, and practical aspects of intervention delivery will additionally be monitored. The pilot trial is not designed or powered to evaluate the effectiveness of StressModex.
Persistent post-traumatic neck pain is associated with substantial disability, reduced quality of life, psychological distress, and societal costs. Previous research has identified psychological stress responses and hyperarousal symptoms following trauma as important predictors of poor recovery. Interventions combining physical rehabilitation with psychological approaches may therefore be relevant for individuals at increased risk of persistent post-traumatic neck pain.
StressModex integrates guideline-based physiotherapy with Stress Inoculation Training (SIT) and has previously been adapted to a Danish healthcare context. A preceding feasibility study evaluated the acceptability and feasibility of the adapted intervention and study procedures. While the intervention was found to be acceptable and deliverable, recruitment and retention were identified as important remaining uncertainties. Based on these findings, the recruitment strategy and trial procedures have subsequently been revised.
Building on this previous adaptation and feasibility work, the present study is designed as a two-arm randomised pilot trial. The aim is to assess the feasibility of conducting a future definitive RCT evaluating StressModex plus treatment as usual (TAU) compared with TAU alone and to generate information required to refine the design of the definitive trial.
Adults with post-traumatic neck pain of less than six months' duration who demonstrate both moderate neck-related disability and hyperarousal symptoms will be recruited through a revised multi-source recruitment strategy, including emergency departments, hospital records, healthcare providers and settings, health insurance providers, and public advertisements including social media. Following informed consent and completion of baseline questionnaires, participants will be randomised in a 1:1 ratio to either StressModex plus TAU or TAU alone.
StressModex consists of 10 physiotherapy sessions delivered over six weeks and combines individually tailored, guideline-based physiotherapy with SIT. SIT is integrated into six sessions and focuses on understanding and managing stress responses, developing coping and stress-management skills, and applying these skills in relevant situations. Participants in both trial arms remain free to seek healthcare according to usual Danish practice.
The primary objectives are to assess whether the revised multi-source recruitment strategy can identify and include eligible participants at a rate sufficient to support a future definitive RCT and to assess participant retention and the feasibility and completeness of remote outcome data collection through 6 months. Secondary objectives are to assess the feasibility and acceptability of randomisation, characterise TAU, and concurrent healthcare use and potential overlap with the StressModex intervention, and estimate parameters relevant to the sample size calculation for a future definitive RCT. Intervention fidelity, adherence, acceptability, safety, and practical aspects of intervention delivery will additionally be monitored.
Clinical outcomes, including neck-related disability, pain, psychological symptoms, quality of life, and physical activity, will be collected primarily to assess the feasibility and completeness of outcome data collection and, where relevant, to estimate parameters required to inform the design of a future definitive RCT. Register-based data on healthcare utilisation, medication use, and work participation will also be collected to inform procedures and the design of a future health-economic evaluation. The pilot trial is not powered to evaluate clinical effectiveness, and no confirmatory between-group effectiveness testing is planned. Participants will be followed for six months after randomisation.
62 studies on the registry are indexed under Whiplash Injuries; 9 are open to participants now.
This study's planned enrollment of 30 is below the median of 61 across 44 interventional studies indexed under Whiplash Injuries.
Browse Whiplash Injuries studies →University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to this arm will receive StressModex in addition to treatment as usual (TAU). StressModex comprises 10 physiotherapy sessions delivered over six weeks and combines individually tailored, guideline-based physiotherapy with Stress Inoculation Training (SIT). SIT is integrated into six of the 10 sessions. Participants remain free to seek additional healthcare according to usual Danish practice throughout the study period.
Behavioral: StressModex plus Treatment as Usual
Participants allocated to this arm will not receive the StressModex intervention. They will continue with treatment as usual and remain free to seek healthcare according to usual Danish practice, including consultation with their general practitioner and treatment from other healthcare providers as considered necessary.
StressModex is a physiotherapist-delivered intervention combining guideline-based exercise therapy with stress inoculation training. Participants receive 10 treatment sessions over six weeks. Exercise components target neck mobility, strength, endurance, and sensorimotor function. Stress inoculation training components are integrated into six sessions and focus on stress education, relaxation strategies, coping skills, and self-management of stress-related symptoms following trauma.
Recruitment rate
Recruitment rate will be assessed as the number of participants randomised per month during the active recruitment period. Recruitment will be evaluated against prespecified progression criteria: ≥5 participants per month (go), 3 to \<5 participants per month (amend), and \<3 participants per month (stop/reconsider).
Time frame: Throughout the active recruitment period, up to 10 months
Participant retention at 6-month follow-up
Retention will be assessed as the proportion of randomised participants retained at the 6-month follow-up. Retention will be evaluated against prespecified progression criteria: ≥75% retention (go), 50 to \<75% retention (amend), and \<50% retention (stop/reconsider).
Time frame: 6 months after randomisation
Participant retention at 6-week and 3-month follow-up
Retention will be assessed as the proportion of randomised participants retained at each follow-up time point. Reasons for withdrawal or loss to follow-up will be recorded where available.
Time frame: 6 weeks and 3 months after randomisation
Completeness of remotely collected outcome data
Completeness of remotely collected outcome data will be assessed at each time point. The proportion of participants providing complete NDI data will be reported separately, as NDI is the proposed primary clinical outcome for a future definitive RCT. NDI data completeness of ≥80% will be considered acceptable, 70 to \<80% will indicate that modifications to data collection procedures should be considered, and \<70% will indicate substantial feasibility concerns. Completeness of the remaining questionnaire battery will also be described.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Acceptance of randomisation
Acceptance of randomisation will be assessed as the proportion of eligible individuals invited to participate in the trial who provide informed consent to participation and randomisation. Reasons for declining participation will be recorded where available. Acceptance of ≥80% will be considered acceptable, 60 to \<80% will indicate that modifications to recruitment or trial information procedures should be considered, and \<60% will indicate substantial concerns regarding the feasibility of the randomised design
Time frame: At enrolment, prior to randomisation
Withdrawal following treatment allocation
The proportion of randomised participants who withdraw from the study following treatment allocation will be assessed by trial arm. Reasons for withdrawal, including reasons related to treatment allocation, will be recorded where available.
Time frame: From randomisation to 6-month follow-up
Treatment as usual and concurrent healthcare use
Healthcare use will be assessed by participant report, including the type and extent of healthcare received and medication use. Data will be used to characterise treatment as usual and concurrent healthcare use in both trial arms and to identify potential overlap between usual care and components of StressModex.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Intervention fidelity
Intervention fidelity will be assessed using therapist-completed standardised checklists after each treatment session, documenting delivery of the core StressModex intervention components. Fidelity will be summarised as the proportion of planned core intervention components delivered as intended.
Time frame: Throughout the 6-week intervention period
Intervention adherence and completion
Intervention adherence will be assessed based on initiation and completion of the intervention, attendance at scheduled treatment sessions, and participant-reported adherence to prescribed home exercises. Treatment attendance will be summarised as the proportion of scheduled sessions attended.
Time frame: Throughout the 6-week intervention period
Acceptability of the StressModex intervention
Acceptability of the StressModex intervention will be explored among participants allocated to the intervention through semi-structured interviews. Interviews will address participants' experiences of the intervention, including perceived relevance, burden, barriers and facilitators to participation, application in everyday life, and practical aspects of treatment delivery, as well as their general reflections also on symptom development.
Time frame: 6 weeks, 3 months and 6 months after randomisation
Clinician perspectives on intervention delivery and implementation
Clinicians delivering StressModex will participate in semi-structured interviews exploring experiences of intervention delivery, implementation, barriers, facilitators, and practical considerations relevant to a future definitive RCT.
Time frame: Following intervention delivery
Variability of Neck Disability Index score to inform a future definitive RCT
Neck-related disability will be measured using the Neck Disability Index (NDI). The variability of NDI scores will be estimated to provide trial-specific information for refinement of the sample size calculation for a future definitive RCT. Estimates will be interpreted alongside relevant external evidence and will not be used for confirmatory effectiveness testing
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Pain intensity
Pain intensity during the previous 24 hours will be measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Post-traumatic stress symptoms
Post-traumatic stress symptoms will be assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). The total score ranges from 0 to 80, with higher scores indicating greater post-traumatic stress symptom severity and therefore a worse outcome.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Hyperarousal symptoms
Hyperarousal symptoms will be assessed using the hyperarousal subscale of the Posttraumatic Diagnostic Scale (PDS). The subscale score ranges from 0 to 15, with higher scores indicating greater hyperarousal symptom severity.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Depression, anxiety, and stress symptoms
Symptoms of depression, anxiety, and stress will be assessed using the 21-item Depression Anxiety Stress Scales (DASS-21). The instrument comprises three subscales: depression, anxiety, and stress. Each subscale score ranges from 0 to 42, with higher scores indicating greater symptom severity
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Pain catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Pain self-efficacy
Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). The total score ranges from 0 to 60, with higher scores indicating greater confidence in performing activities despite pain
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Health-related quality of life
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Health states will be converted to an EQ-5D-5L index value using the Danish value set, with higher values indicating better health-related quality of life.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Health related quality of life - EQ VAS
The EQ Visual Analogue Scale (EQ VAS) ranges from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state; higher scores indicate a better outcome
Time frame: Baseline, 6 weeks, 3 months and 6 months
Sleepiness
Subjective sleepiness will be assessed using the Karolinska Sleepiness Scale (KSS). The scale ranges from 1 to 9, with higher scores indicating greater subjective sleepiness
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Expected recovery
Participants' expectations of recovery will be assessed using an 11-point numerical rating scale ranging from 0% to 100%, with higher scores indicating greater expected recovery.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Pain characteristics
Pain characteristics will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), which assesses sensory and affective qualities of pain and pain intensity. Higher scores indicate greater pain severity.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Treatment credibility and expectancy
Treatment credibility and expectancy will be assessed using the Credibility/Expectancy Questionnaire (CEQ). The questionnaire comprises two subscales: treatment credibility and treatment expectancy. Credibility is assessed using three items rated from 1 to 9, while expectancy is assessed using two items rated from 1 to 9 and one item rated from 0% to 100%. Higher scores indicate greater treatment credibility and more positive expectations of treatment outcome.
Time frame: Baseline
Physical activity
Self-reported physical activity will be assessed using a standardised physical activity questionnaire
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Global Rating of Change
Participants' perceived overall change in their neck condition will be assessed using the Global Rating of Change (GROC) scale. Scores range from -7 ("a very great deal worse") to +7 ("a very great deal better"), with 0 indicating no change. Higher scores indicate greater perceived improvement
Time frame: 6 weeks, 3 months, and 6 months
Global Perceived Effect
Participants' perceived overall effect of treatment will be assessed using the Global Perceived Effect (GPE) scale. The scale ranges from 1 to 7, with higher scores indicating a greater perceived positive effect of treatment.
Time frame: 6 weeks, 3 months, and 6 months
Patient Acceptable Symptom State
Patient Acceptable Symptom State (PASS) will be assessed using a single patient-reported item indicating whether participants consider their current symptom state acceptable.
Time frame: 6 weeks, 3 months, and 6 months
Treatment Failure
Treatment failure will be assessed using a single patient-reported item indicating whether participants consider their treatment unsuccessful.
Time frame: 6 weeks, 3 months, and 6 months
Current stress level
Current perceived stress will be assessed using an 11-point numerical rating scale (NRS), with higher scores indicating greater perceived stress.
Time frame: Baseline, 6 weeks, 3 months, and 6 months
Register-based healthcare utilisation, medication use, and work participation
Register-based data will be collected on healthcare utilisation, medication use, and work participation to describe healthcare and societal resource use and to inform the design of a health-economic evaluation in a future definitive RCT. If possible with actual sample size
Time frame: From 1 year before inclusion to 1 year after inclusion
Adverse Events
Adverse events (AEs) will be monitored throughout the study through participant self-report and therapist reporting during the intervention period. Transient symptom fluctuations or short-term pain associated with physical activity, exercise, or gradual return to usual activities will not in themselves be classified as AEs. Such events will be recorded as AEs if they are unexpected, result in substantial additional burden to the participant, or lead to healthcare contact.
Time frame: From randomisation to 6 months
Serious Adverse Events
Serious adverse events (SAEs) will be monitored throughout the study through participant self-report and therapist reporting during the intervention period. SAEs will include events resulting in hospitalisation, significant disability, risk of permanent harm, or another serious medical condition. SAEs will be recorded and reported in accordance with applicable regulatory and ethical requirements.
Time frame: From randomisation to 6 months
Plan to share: Undecided — The study team has not yet made a final decision regarding the sharing of de-identified individual participant data. Any future data sharing will be conducted in accordance with applicable data protection regulations, institutional policies, and ethical approvals.
Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.
Of 20 interventional studies with no phase under Whiplash Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 38. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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