Evidence map›Paper›PMID 42163374›Full record

Trial reportTrials2026

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

Angelo Compare, Antonino La Tona, Cristina Masella, Mattia Vincenzo Olive, Agostino Brugnera, Vivian Ostwald, Antonino Carcione, Luca Pievani, Barbara Poletti, Giorgio Angelo Tasca and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06356961 (Routine Outcome Monitoring and Feedback Informed Therapy in Italy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06356961 narecruitingnot on this map

Routine Outcome Monitoring and Feedback Informed Therapy in Italy: 1st Italian RCT Large Population Study (PRIN - Italian Minister of Universities and Research Project)

TypeinterventionalSponsorUniversity of BergamoRan2025 to 2025Enrolled180ConditionsFeedback, PsychologicalArms(Feedback Informed Therapy) with Clinical Support Tools and ah hoc training, Feedback and ROM (basic)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Angelo Compare *Department of Human and Social Sciences, University of Bergamo, P.Le S. Agostino 2, Bergamo, 24129, Italy.
Antonino La Tona *Department of Human and Social Sciences, University of Bergamo, P.Le S. Agostino 2, Bergamo, 24129, Italy. antonino.latona@unibg.it.
Cristina MasellaDepartment of Management, Economics and Industrial Engineering, Politecnico di Milano, Milan, Italy.
Mattia Vincenzo OliveDepartment of Management, Economics and Industrial Engineering, Politecnico di Milano, Milan, Italy.
Agostino BrugneraDepartment of Human and Social Sciences, University of Bergamo, P.Le S. Agostino 2, Bergamo, 24129, Italy.
Vivian OstwaldDepartment of Psychology, Educational Science and Human Movement, University of Palermo, Palermo, Italy.
Antonino CarcioneDepartment of Human Science, "G. Marconi" University, Rome, Italy.
Luca PievaniScuola di Psicoterapia Integrata, Bergamo, Italy.
Barbara PolettiScuola di Psicoterapia Integrata, Bergamo, Italy.
Giorgio Angelo TascaSchool of Psychology, University of Ottawa, Ottawa, Canada.
Gianluca Lo CocoDepartment of Psychology, Educational Science and Human Movement, University of Palermo, Palermo, Italy.

Funding

Ministero dell'Università e della Ricerca 2022Z4BB82Ministero dell'Università e della Ricerca n. 901-SH4 (MUR-PRIN 2022)
6 · The paper itself

Abstract

backgroundRoutine 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.

methodsThe 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. DISCUSSION: 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.

trial registrationClinicalTrials.gov NCT06356961 . Registered on April 10, 2024.

Indexed as

Ambulatory CareFeedback, PsychologicalOutpatientsPsychotherapistsPsychotherapyHumansItalyTime FactorsTreatment OutcomeFeedback-informed therapy (FIT)MindyOutProFeed-ItalyRoutine outcome monitoring (ROM)Therapeutic alliance

Identifiers

PMID42163374
PMCPMC13366923

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.