Targeting excessive worry with internet-based extinction therapy: a randomised controlled trial with mediation analysis and economical evaluation

Abstract

AbstractBackgroundExcessive worry is a common phenomenon. Our research group has previously developed an online intervention for excessive worry based on operant principles of extinction (IbET; internet-based extinction therapy) and tested it against a waiting-list. The aim of this study was to evaluate IbET against an active control comparator (CTRL).MethodsA 10-week parallel participant blind randomised controlled trial with health-economical evaluation and mediation analyses. Participants (N = 311) were randomised (ratio 4.5:4.5:1) to IbET, to CTRL (an internet-based stress-management training program) or to waiting-list. The nation-wide trial included self-referred adults with excessive worry. The primary outcome was change in worry assessed with the Penn State Worry Questionnaire from baseline to 10 weeks.ResultsIbET had greater reductions in worry compared to CTRL [−3.6 point difference, (95% CI −2.4 to −4.9)] and also a significantly larger degree of treatment responders [63% v. 51%; risk ratio = 1.24 (95% CI 1.01–1.53)]. Both IbET and CTRL made large reductions in worry compared to waiting-list and effects were sustained up to 1 year. Treatment credibility, therapist attention, compliance and working alliance were equal between IbET and CTRL. Data attrition was 4% at the primary endpoint. The effects of IbET were mediated by the hypothesized causal mechanism (reduced thought suppression) but not by competing mediators. Health-economical evaluation indicated that IbET had a 99% chance of being cost-effective compared to CTRL given societal willingness to pay of 1000€.ConclusionsIbET is more effective than active comparator to treat excessive worry. Replication and extensions to real-world setting are warranted.