OutProFeed-Italy: A Randomized Controlled Trial of Routine Outcome Monitoring and Feedback Informed Psychotherapy
Bibliographic record
Abstract
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]
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.009 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.019 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".