Using feedback-informed therapy to improve mental health outcomes in Italy
Routine Outcome Monitoring and Feedback Informed Therapy in Italy: 1st Italian RCT Large Population Study (PRIN - Italian Minister of Universities and Research Project)
This study is testing whether using regular feedback from patients during therapy can help improve mental health outcomes for adults in Italy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bergamo Academic / other |
| Locations | 2 sites (Bergamo, Italia and 1 other locations) |
| Trial ID | NCT06356961 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with psychosis or neurocognitive disorders may not benefit from this study due to the specific clinical considerations involved.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health outcomes for patients undergoing psychotherapy.
How similar studies have performed: Other studies have shown success with feedback-informed therapy and routine outcome monitoring, indicating a promising approach to enhancing psychotherapy effectiveness.
Eligibility criteria
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 this trial is running
Bergamo, Italia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.