Preliminary efficacy of a self-guided mobile intervention for reducing stress in depression: A randomized controlled...

Stress worsens clinical outcomes in patients with major depressive disorder (MDD); however, timely accessible stress management tools remain limited. Digital interventions offer scalable adjunctive solutions early during pharmacological treatment. In this multicenter, assessor-blinded, randomized controlled crossover pilot trial, we conducted a preliminary evaluation of the short-term efficacy of a self-guided digital health intervention (inMind) in reducing psychological stress in individuals with mild-to-moderate MDD undergoing pharmacological treatment. We randomly assigned 39 participants to the App-first or Delayed-app sequence, with 36 analyzed. inMind comprised cognitive-behavioral therapy and mindfulness-based stress-reduction modules, relaxation audio, and heart-rate-variability-based stress monitoring. The primary outcome was change in the Depression Anxiety Stress Scales-Stress subscale (DASS-Stress), with secondary measures of depression, anxiety, and perceived stress. Analyses followed a modified intention-to-treat approach using linear mixed-effects models. The inMind condition was associated with a reduction in DASS-Stress (estimate = -2.41; p = 0.047), narrowly exceeding the published minimum clinically important difference, with directionally consistent reductions in depressive and anxiety symptoms. Significant carry-over effects complicated causal interpretation under the no-washout design. Usage metrics showed no significant association with outcomes, consistent with a low-intensity, flexible intervention. Adherence was high in both groups. These preliminary findings suggest that inMind, a 4-week self-guided digital adjunct, may produce modest short-term reductions in stress, depression, and anxiety alongside pharmacotherapy in mild-to-moderate MDD; if confirmed in adequately powered trials, such tools may complement pharmacotherapy and inform future digital adjuncts.