OutProFeed-Italy: A Randomized Controlled Trial of Routine Outcome Monitoring and Feedback Informed Psychotherapy

Abstract Background: Routine outcome monitoring with immediate clinical feedback can improve the effectiveness of psychotherapy. This protocol study represents the first Italian randomized controlled trial (RCT) to evaluate the effectiveness of Feedback Informed Therapy (FIT) to improve patient mental health outcomes and processes. In it, we test a state-of-the-art digital platform (named Mindy) designed and developed for therapists that includes an integrated monitoring and support system. Methods: This longitudinal RCT (Zellen design) involves randomizing therapists and their patients who meet the inclusion criteria into three conditions. The first condition involves outcome and process monitoring (OPM). In this condition, patients complete outcome and process measures related to each psychotherapy session, therapists use the Mindy platform to monitor the outcome and process measures, but therapists do not receive feedback with clinical support tools. The second condition involves outcome and process monitoring plus feedback (OPM-F). In this condition patients complete outcome and process measures related to each session and therapists receive feedback on the Mindy platform’s Clinical Support Tools based on the principles of feedback-informed therapy (FIT). Therapists in the OPM-F condition also receive monthly supervision/coaching for three months aimed at enhancing their use of the Clinical Support Tools. The third condition is treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would, and therapists do not receive training. Therapists only use the Mindy platform as a streamlined digital record and to fill out the process evaluations at pre-treatment (after the first session) and the last study session (15th session) but without access to the data. In addition, therapists and patients in all conditions complete outcome questionnaires at pre-treatment, post-treatment and follow-up. Discussion: We expect that compared to the other conditions, patients treated by therapists in the OPM-F condition will experience greater reductions in symptoms, lower dropout rates, and a better therapeutic alliance. Therapists in the OPM-F condition will demonstrate better management of therapeutic alliance ruptures. Overall, the results of this study could encourage future decisions on the use of digital platforms (e.g., Mindy) and FIT. Study registration: April 10, 2024 [https://clinicaltrials.gov/study/NCT06356961]