Smartphone-Based Mindfulness and Mentalization Ecological Momentary Interventions for Common Mental Health Problems: Pilot Randomized Controlled Trial.

Abstract

Background: Accessible ecological momentary interventions deliver brief, real-time support integrated into daily routines. Interpersonal dynamics and maladaptive coping mechanisms can contribute to an individual's anxiety and depression. Both mindfulness and mentalization represent psychological constructs with the potential to mitigate the negative impact of interpersonal stressors.

Objective: This study aims to assess the feasibility and acceptability of an automated mindfulness- and mentalization-based ecological momentary intervention for common mental health problems as delivered via a mobile phone app.

Methods: The design was a parallel-group pilot randomized controlled trial with 1:1 allocation ratio and exploratory framework. Recruitment of participants experiencing common mental health issues was internet-based from a university setting. Eligible participants were randomly allocated to fully automated mindfulness- or mentalization-based ecological momentary interventions via computer-generated randomization. Participants were blind to the alternative intervention options. Outcomes were self-assessed through questionnaires after 4 weeks. Primary outcomes were feasibility (recruitment, retention, and adherence) and acceptability (satisfaction ratings and qualitative feedback). Secondary outcomes included changes in depression (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalized Anxiety Disorder Questionnaire-7 [GAD-7]) scores.

Results: A total of 84 participants were randomized (42 to each group). The interventions demonstrated good feasibility with an 89.2% retention rate and a mean adherence of 87.69% (SD 11.3%) across both groups. Acceptability ratings were positive, with favorable scores for ease of engagement (mean 5.20, SD 1.6), overall enjoyment (mean 5.15, SD 1.2), and likelihood of recommending the app (mean 5.11, SD 1.6) on a 7-point scale. For primary outcomes, both groups showed significant within-group reductions in PHQ-9 and GAD-7 scores, with moderate to large effect sizes (Cohen d=-0.68 to -0.81), with no significant difference between groups. Both treatments demonstrated clinically significant change, with 33 (44%) participants in both groups no longer meeting caseness criteria for anxiety and depression. Mindfulness performed better on improving assertiveness and perceived support compared to mentalization in the ecological momentary assessment data. One unintended harm was reported in the mindfulness arm, whereas none was reported in the mentalization arm.

Conclusions: This pilot trial suggests that both mindfulness- and mentalization-based ecological momentary interventions are feasible and acceptable for individuals with common mental health problems and warrant further evaluation.