Routine Outcome Monitoring and Feedback Informed Therapy in Italy

NCT06356961 | Recruiting DMC

• 1 other identifier: 2022Z4BB82
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy. The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan. Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following: I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy. Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/). Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. 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). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables.

Conditions

Feedback, Psychological

Keywords

Routine outcome monitoring (ROM); PRIN-Italy-OutProFeed.; Feedback informed therapy (FIT)

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Symptom severity (GAD7-PHQ9) in OPM-F,OPM and TAU conditions at T2 (up to 6 months), and follow up (3 months)

  Patients whose therapists were in the OPM-F condition will have better results in terms of reduction of symptom severity (GAD7-PHQ9) at the end of treatment (after 15 sessions/up to 6 months) and three months after treatment (follow up) than patients of therapists in the OPM condition and TAU condition. GAD is a 7-item self-report screening instrument for the assessment of generalized anxiety disorder (GAD). Each item is rated on a 4-point Likert scale (0 = "Not at all" to 3 = "Almost every day"), with higher scores reflecting greater severity of GAD. Patient Health Questionnaire is a 9-item self-report instrument that assesses symptoms of depression. Each item is rated on a 4-point Likert scale (0 = "Not at all" to 3 = "Almost every day"), with higher scores indicating greater severity of depression.

  Baseline, T2 (up to 6 months), Follow-up (3 months)

• Clinical Outcomes in Routine Evaluation-10 (Change in Session by session)

  Patients whose therapists were in the OPM-F condition will have better results in terms of decreasing distress (CORE-10) from session to session than patients of therapists in the OPM condition and the TAU condition. Patients whose therapists were in the OPM condition will have better results in terms of decreasing discomfort (CORE-10) from session to session than patients of therapists in the TAU condition. CORE-10 is a short 10-item measure to explore psychological distress developed for outcome monitoring in clinical settings Items are rated on a 5-point Likert-type scale (from 0 = not at all to 4 = most or all of the time), and higher total scores (i.e., the sum of all items, ranging from 0 to 40) indicate greater distress.

  Session by session (every weeks from baseline to up to 6 months)

• Working Alliance Inventory-Short Revised-Client (Change in session by session)

  Patients of therapists in the OPM-F condition will report a greater increase in therapeutic alliance during therapy sessions than patients in the OPM and TAU conditions. Patients of therapists in the OPM condition will report a greater increase in therapeutic alliance during therapy sessions than patients in the TAU conditions.

  Session by session (From baseline to up to 6 months)

Secondary Outcomes (2)

• Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes

  T2 (up to 6 months) and follow-up (3 months)

• Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7

  Baseline, T2 (up to 6 months), follow up (3 months)

Study Arms (3)

Treatment as usual (TAU)

NO INTERVENTION

TAU: therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder.

OPM

ACTIVE COMPARATOR

Process and outcome monitoring (OPM) in which patients will complete process and outcome measures with "baseline" feedback related to each psychotherapy session, but therapists will not receive support with clinical support tools on these measures, will not have specific training on Feedback Informed Therapy (FIT), and will not receive monthly supervision, but rather will use the Mindy platform as a medical record

Behavioral: Feedback and ROM (basic)

OPM-F

EXPERIMENTAL

Process and outcome monitoring with feedback (OPM-F) in which patients will complete process and outcome measures related to each session, and therapists will receive feedback on patient progress and patient experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and use the Mindy platform with all information inherent to feedback and Clinical Support Tools, they will also receive monthly supervision/coaching (for three months) designed to complete on-going training on FIT and ROM, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.

Behavioral: (Feedback Informed Therapy) with Clinical Support Tools and ah hoc training; Behavioral: Feedback and ROM (basic)

Interventions

(Feedback Informed Therapy) with Clinical Support Tools and ah hoc training BEHAVIORAL

Therapists in the condition (OPM-F) will receive specific training on the procedures and techniques inherent in feedback informed therapy (FIT); during the intervention phase (lasting 15 sessions) the Clinical Support System in FIT will guide them in the clinical application of the procedures. In addition, they will receive monthly supervision (for three months) apt to provide on-going clinical support on FIT and ROM, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.

OPM-F

Feedback and ROM (basic) BEHAVIORAL

Process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session but therapists will receive basic feedback on these measures

OPM; OPM-F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bergamo: lead
• Politecnico di Milano: collaborator
• Leiden University: collaborator
• University of Ottawa: collaborator
• University of Sheffield: collaborator
• Brigham Young University: collaborator
• University of Palermo: collaborator

Study Sites (2)

University of Bergamo (DSUS)

Bergamo, Italia, 24125, Italy

RECRUITING

University of Bergamo

Bergamo, Italia, 24125, Italy

RECRUITING

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MeSH Terms

Interventions

Alkalies

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Gianluca Lo Coco, Full Professor

  University of Palermo (Italy)

  PRINCIPAL INVESTIGATOR

• Masella Cristina, Full Professor

  "Politecnico" Milan (Italy)

  PRINCIPAL INVESTIGATOR

• Giorgio A. Tasca, Full Professor

  School of Psychology, University of Ottawa (Canada)

  PRINCIPAL INVESTIGATOR

• Barbara Poletti, Professor

  Scuola di Psicoterapia Integrata (Bergamo) Italy

  PRINCIPAL INVESTIGATOR

• Luca Pievani, Dr.

  Scuola di Psicoterapia Integrata (Bergamo) Italy

  PRINCIPAL INVESTIGATOR

• Antonino Carcione, Professor

  Terzocentro di Psicoterapia Cognitiva (Roma) Italy

  PRINCIPAL INVESTIGATOR

• Antonino La Tona, Dr.

  University of Bergamo (Italy)

  PRINCIPAL INVESTIGATOR

• Mattia V. Olive, Dr.

  "Politecnico" Milan (Italy)

  PRINCIPAL INVESTIGATOR

• Agostino Brugnera, Assistant Professor

  University of Bergamo

  PRINCIPAL INVESTIGATOR

• Gary M. Burlingame, Full Professor

  Brigham Young University (Utah)

  PRINCIPAL INVESTIGATOR

• Kim De Jong, Full Professor

  Leiden University

  PRINCIPAL INVESTIGATOR

• Michael Barkham, Full Professor

  University of Sheffield

  PRINCIPAL INVESTIGATOR

• Jaime Delgadillo, Full Professor

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Compare, Full Professor

CONTACT

+39 0352052989; angelo.compare@unibg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Angelo Compare

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 10, 2024
• Study Start: March 25, 2025
• Primary Completion: August 28, 2025
• Study Completion: October 5, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)