OutProFeed-Italy: a cluster randomized controlled trial of routine outcome monitoring and feedback-informed...

Routine outcome monitoring (ROM) with timely feedback to therapists may improve psychotherapy outcomes. OutProFeed-Italy is a protocol for a three-arm cluster randomized controlled trial (RCT) using a Zelen design to test whether feedback-informed therapy (FIT) delivered through a digital platform (Mindy) improves patient outcomes and therapeutic processes in routine outpatient psychotherapy in Italy.

The study will recruit psychotherapy trainees and licensed psychotherapists practicing in Italy (licensed psychotherapists or trainees in ≥3rd year of an Italian Ministry of University and Research-recognized psychotherapy program) and their adult outpatients (≥18 years, with fewer than three sessions with the participating therapist; excluding psychotic and neurocognitive disorders). Therapists will be recruited by the research team through universities and professional networks, and each therapist will recruit 2-5 eligible patients from routine outpatient practice. Therapists (clusters) will be randomized 1:1:1 by an independent statistician to three conditions: (1) outcome and process monitoring only (OPM), with session-by-session measures results of which are displayed to therapists but without feedback with clinical support tools (CST); (2) outcome and process monitoring plus feedback (OPM-F), in which therapists receive feedback through Mindy's clinical support tools based on FIT principles, together with monthly supervision for 3 months; and (3) treatment as usual (TAU), with no monitoring or feedback, and assessments only at baseline, session 15, and 3-month follow-up. The planned sample size is 182 therapists (61 per arm) and approximately 546 patients. The primary outcomes are symptom severity from baseline to session 15 and 3-month follow-up; secondary outcomes include psychological distress, therapeutic alliance, and dropout rates. Safety will be monitored through repeated symptom and risk assessments and the recording of adverse events and withdrawals, with referral procedures as needed. First enrollment started in November 2024.

We hypothesize that, compared with OPM and TAU, patients treated by therapists in the OPM-F condition will show greater symptom improvement, fewer dropouts, and better therapeutic alliance trajectories. Findings may inform the implementation of ROM and FIT supported by digital platforms in Italian routine care.

ClinicalTrials.gov NCT06356961 . Registered on April 10, 2024.