Are People Worse Off in a Mental Health Treatment Paradigm Where Medication Is Deemphasised? A Naturalistic Noninferiority Trial of an Initiative to Improve Patient Choice

Background: Norwegian health authorities have established dedicated units for medication-free mental health treatment (MFT) to enhance patient choice. These services place greater emphasis on psychosocial and psychotherapeutic interventions than traditional care. They aim to be free from coercion and pressure regarding medication, rather than totally absent of medication. Aims: This study evaluates whether outcomes for patients receiving MFT are noninferior to those receiving treatment as usual (TAU). Method: A noninferiority analysis was conducted using the Outcome Questionnaire-45.2 (OQ-45.2) to assess changes from admission to discharge. Two datasets were analysed: a smaller research sample with repeated measures and two comparison units (Sample R; n = 59 + 124), and a larger quality register sample with single-measure data and one comparison unit (Sample Q; n = 140 + 238). In sample R, associations between clinical and demographic variables and treatment outcomes were also explored. Results: Participants in both treatment conditions showed substantial improvement. In Sample R, changes between groups were not statistically significant, and the noninferiority analysis was inconclusive. In Sample Q, intention-to-treat analyses indicated superiority for MFT, while sensitivity analyses excluding dropouts supported noninferiority. Conclusions: Findings suggest that MFT is not associated with inferior short-term treatment outcomes in the population currently receiving this care. These results may reassure clinicians and policymakers in supporting patient choice and may assist patients in selecting their preferred treatment approach. This study is registered at ClinicalTrials.gov (NCT03499080), date 17/04/2018.