Using feedback-informed therapy to improve mental health outcomes in Italy
Official title: Routine Outcome Monitoring and Feedback Informed Therapy in Italy: 1st Italian RCT Large Population Study (PRIN - Italian Minister of Universities and Research Project)
Run by University of Bergamo · NCT06356961 · Data updated 2026-11-12
This study is testing whether using regular feedback from patients during therapy can help improve mental health outcomes for adults in Italy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | University of Bergamo Academic / other |
| Locations | 2 sites (Bergamo, Italia and 1 other locations) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | August 28, 2025 |
| Study ends | October 5, 2025 |
| Registry record updated | March 30, 2025 |
| Trial ID | NCT06356961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients aged 18 and older who are seeking psychotherapy for mental health issues and have had fewer than three therapy sessions.
✕Probably not a fit
Patients with psychosis or neurocognitive disorders may not benefit from this study due to the specific clinical considerations involved.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project evaluates the effectiveness of feedback-informed psychotherapy (FIT) through a digital platform called Mindy. It involves routine outcome monitoring (ROM) to collect patient data regularly, share it with therapists, and adjust therapy based on feedback. The study aims to enhance mental health outcomes for patients by integrating structured feedback into psychotherapy practices. Approximately 1500 to 2000 adult patients will be recruited, with therapists providing care across various psychotherapy modalities.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health outcomes for patients undergoing psychotherapy.
How similar studies have gone: Other studies have shown success with feedback-informed therapy and routine outcome monitoring, indicating a promising approach to enhancing psychotherapy effectiveness.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Terapists with a regular specialisation diploma in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), in activity; and/or specialising in psychotherapy at least in their third year will be selected. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). * Patients: Approximately 1500 to 2000 patients will be recruited, 5 new patients per therapist. * New patients seen for less than 3 sessions. * Adult patients, 18 years of age or older. Exclusion Criteria: * Patients: - No restrictions on diagnoses except for the following: Psychosis and neurocognitive disorders, because as pointed out by Barkham and colleagues when using ROM and FIT the clinical population and context must be considered.
Where it's running
-
University of Bergamo (DSUS)
Bergamo, Italia, Italy Recruiting -
University of Bergamo
Bergamo, Italia, Italy Recruiting
Study contacts
- Principal investigator: Gianluca Lo Coco, Full Professor — University of Palermo (Italy)
- Study coordinator: Angelo Compare, Full Professor
- Email: angelo.compare@unibg.it
- Phone: +39 0352052989
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.