Abstract

BACKGROUND Neck-specific exercises (NSE) supervised by a physiotherapist twice a week for 12 weeks have shown good results in chronic whiplash-associated disorders (WADs), but the effect of exercise delivered via the internet is unknown. OBJECTIVE This study examined whether NSE with internet support (NSEIT) and 4 physiotherapy sessions for 12 weeks were noninferior to the same exercises supervised by a physiotherapist twice a week for 12 weeks (NSE). METHODS In this multicenter randomized controlled noninferiority trial with masked assessors, we recruited adults aged 18-63 years with chronic WAD grade II (ie, neck pain and clinical musculoskeletal signs) or III (ie, grade II plus neurological signs). Outcomes were measured at baseline and at 3- and 15-month follow-ups. The primary outcome was change in neck-related disability, measured with the Neck Disability Index (NDI; 0%-100%), with higher percentages indicating greater disability. Secondary outcomes were neck and arm pain intensity (Visual Analog Scale [VAS]), physical function (Whiplash Disability Questionnaire [WDQ] and Patient-Specific Functional Scale [PSFS]), health-related quality of life (EQ-5D-3L and EQ VAS), and self-rated recovery (Global Rating Scale [GRS]). The analyses were conducted on an intention-to-treat basis and with the per-protocol approach as sensitivity analyses. RESULTS Between April 6, 2017, and September 15, 2020, 140 participants were randomly assigned to the NSEIT group (n=70) or the NSE group (n=70); 63 (90%) and 64 (91%), respectively, were followed up at 3 months, and 56 (80%) and 58 (83%), respectively, at 15 months. NSEIT demonstrated noninferiority to NSE in the primary outcome NDI, as the 1-sided 95% CI of the mean difference in change did not cross the specified noninferiority margin (7 percentage units). There were no significant between-group differences in change in NDI at the 3- or 15-month follow-up, with a mean difference of 1.4 (95% CI -2.5 to 5.3) and 0.9 (95% CI -3.6 to 5.3), respectively. In both groups, the NDI significantly decreased over time (NSEIT mean change -10.1, 95% CI -13.7 to -6.5, effect size=1.33; NSE: mean change -9.3, 95% CI -12.8 to -5.7, effect size=1.19 at 15 months; P<.001). NSEIT was noninferior to NSE for most of the secondary outcomes except for neck pain intensity and EQ VAS, but post hoc analyses showed no differences between the groups. Similar results were seen in the per-protocol population. No serious adverse events were reported. CONCLUSIONS NSEIT was noninferior to NSE in chronic WAD and required less physiotherapist time. NSEIT could be used as a treatment for patients with chronic WAD grades II and III. TRIAL REGISTRATION ClinicalTrials.gov NCT03022812; https://clinicaltrials.gov/ct2/show/NCT03022812.

Abstract

Importance: Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited. Objective: To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety. Design, Setting, and Participants: This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020. Interventions: Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT. Main Outcomes and Measures: Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54. Results: Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported. Conclusions and Relevance: In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety. Trial Registration: ClinicalTrials.gov Identifier: NCT02314065.