Routine Outcome Monitoring and Feedback Informed Therapy in Italy

\- Backgrounds:

Routine outcome monitoring (ROM), including feedback, has its roots in the practice-based evidence paradigm, particularly patient-centered research. The administration of outcome measures, either continuously or at regular intervals as a means of checking progress and informing treatment decision making, can produce an ameliorative effect in addition to the effects produced by standard psychological therapies. ROM has been referred to by various terms, but they all contain features that can be grouped into three sequential steps: (i) collecting patient data in a regular and structured manner; (ii) providing the data to the therapist and, on many occasions, to the patient as well; and (iii) when appropriate, adjusting the process or focus of therapy in light of the feedback that emerged. These three steps have been presented as a transtheoretical model of measurement-based care- Collect, Share, Act -while a definition of ROM that captures these three steps describes it as the implementation of standardized measures, usually session by session, to guide clinical decision making, monitor treatment progress, and indicate when functional modification of treatment is needed. ROM has been presented as a relatively simple evidence-based practice that the clinician can add to any type of psychotherapy without requiring changes in that psychotherapy. The use of ROM and feedback in routine care has long been recommended. A recent advisory committee advocated for professional practice guidelines that focus on measurement-based care and feedback. These guidelines include a statement that therapists should engage in regular evaluation of the treatment process and outcomes, incorporating this information into ongoing collaboration with patients. International scientific organizations are called to increasingly use Feedback Informed Therapy (FIT) and the use of ROM, to assess outcomes, inform goals, objectives,and to monitor individual progress and guide decisions about individual care, treatment or service plans. The use of ROM is also supported by the Roadmap for Mental Health Research in Europe. In addition, national policymakers and regulatory bodies in some countries have made measurement of treatment outcomes mandatory.

ROM has been widely adopted in various therapeutic modalities for adults, for example, in psychodynamic therapy, couples therapy, and group therapy, as well as for specific problems such as substance abuse and in youth settings. It is a pan-theoretical approach and, as a therapeutic method, combines elements of supervision, ongoing assessment, and overall quality assurance.

In addition to considerations of the effects and benefits of ROM, there is also a relevant component of substantial change in the practice of professional activity in the project due to the introduction of digital technology. While there is consensus in the scientific community that digital can be of benefit to professionals, similarly, evidence indicates that such benefits occur under various conditions, including the effective integration of these technologies into daily practice. In this scenario, the possession and development of appropriate skills in the use of digital tools assumes a central role.

Equally central to the implementation of digitally supported ROM is the usability of digital technology, which will be tested through special experience and usability questionnaires on both the patient and therapist sides. Usability will also be assessed through targeted interviews with a subsample of psychotherapists, following the track of validated technology usability questionnaires and analyzed through thematic analysis.

For the reasons expressed so far, the following research project "OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study" is of fundamental scientific and clinical interest. It not only represents the first Italian randomized controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) in improving patients' mental health outcomes and psychotherapy processes, but also obtained PRIN 2022 funding from the Ministry of University and Research.

-Aims and Objectives: The main objective of this study is to conduct the first Italian randomized controlled trial to evaluate the effectiveness of feedback-informed psychotherapy in improving patient mental health outcomes and psychotherapy processes. To achieve this goal, after administering some batteries of questionnaires at baseline (T0) to therapists and patients, previously recruited psychotherapists and their patients will be randomly assigned to one of three conditions: (i) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would, (ii) 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 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 (iii) 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 the patient's progress and the patient's experiences of the therapeutic alliance. Therapists in condition (iii) will receive specific training on the procedures and techniques inherent in feedback informed therapy (FIT), during the intervention phase (duration 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. Therapists will be blinded to the randomization procedure to reduce bias and prejudice. To assess outcomes, psychological distress will be measured before each session and symptom severity at the beginning, at the end of treatment (set at session number 15, up to 6 months) and three months later (follow-up). To evaluate the process in psychotherapy, the level of therapeutic alliance will be assessed after each session. To account for the impact of individual propensity and skills toward digital tools, a clustering of therapists performed on data collected at T0 aimed at creating 'distinct profiles' and non-overlapping respondents with respect to the measured variables will be considered. The therapists involved in the study (in all conditions) after agreeing to the conditions of the study, will be introduced to the use of the digital platform Mindy (they will receive a user manual) and its functionalities (a user manual with technical specifications will be sent to participants and ad hoc training will be organized on its use, declined according to the experimental conditions: TAU (use of the medical record in BASIC mode, without feedback and without routine outcome monitoring, thus only to facilitate standard administration of questionnaires through MINDY and encourage "simple" use of the medical record with the possibility of sitting also online); OPM (use of full MINDY but without the possibility of Clinical Support Tools on Feedback); OPM-F (full use of MINDY with attached Clinical Support Tools on feedback and supervision), as reflected in the research design.

In addition, therapists who are part of the OPM-F condition will receive, after the randomization phase, specific training on feedback informed therapy (FIT) and will use the platform with all the information pertaining to feedback, plus they will receive monthly supervision with the trainer specializing in FIT. The other two conditions will be placed on the "waiting list" and will receive training/supervision later after the experimental phase. The Clinical Support Tools will offer digital alerts that will indicate in the dashboard those conditions defined as "Not on track", i.e., patients who are not responding well to therapy or who are deteriorating in some aspect (outcomes or therapeutic alliance). Scores on the CORE-10 questionnaire that significantly worsen by at least 6 (Reliable Change Index) will be flagged, and a clinical support system will be provided to help the therapist manage the clinical situation with purpose-built charts and questions. Working Alliance Inventory-C scores will be flagged with an alert with the following rationale: (i) First five sessions, the method described will be used, in which the patient's averages (session-by-session) at WAI are used and the possibility of the risk of breakdown is declined with level indications; if the difference between the averages (session-by-session) is between (-0. 25 and +n) there will be a stable WAI, if the difference is between (-0.26 and -1) there will be a moderate rupture risk, while with a drop of one point or more between the two averages (for one or more consecutive sessions) there will be a severe rupture risk alert. (ii) Instead, in the following sessions (sixth through fifteenth), the method described will be used, which involves the use of an idiographic approach, based on the individual patient's "moving average," i.e., an average updates after each assessment made and which also takes into account the previous five assessments. In this case, the risk of breakdown is represented by changes in the total score at the individual patient's WAI with the rationale of using standard deviations from the mean, as a functional indicator: If the score is lower by at least 1.5 (d.s) there will be a moderate alert, 2 d.s will be severe instead. A return within 2-3 sessions to pre-risk levels of rupture (moderate or severe), i.e., increase in scores with raising the mean by at least +1.5/+2 d.s will indicate resolution of rupture.

Management and administration of the tools will be available in the platform in all three conditions, with the differences between the three conditions being detailed. Therapy sessions will be either virtual, on a virtual platform managed and integrated by the platform or live (as needed by the therapist). The decision between virtual vs. in-person session will be investigated through interviews with therapists in the follow-up phase in order to gather drivers leading to the choice. In both cases, the platform will be used for session and patient management and for administering the instruments in a computerized manner.

Primary Hypotheses.

Patients whose therapists were in the OPM-F condition will have better outcomes in terms of reduction in symptom severity from before to six months after treatment than patients of therapists in the OPM condition and the TAU condition.

Patients whose therapists were in the OPM-F condition will have better results in terms of decreasing discomfort from session to session than patients of therapists in the OPM condition and the TAU condition.

Patients of therapists in the OPM condition will have better results in terms of reduction of symptom severity from before to three months after treatment than patients and therapists in the TAU condition.

Patients whose therapists were in the OPM condition will have better results regarding a decrease in discomfort from session to session than therapists in the TAU condition.

Patients of therapists in the OPM-F condition will report greater increases in therapeutic alliance over the course of therapy sessions than patients in the OPM and TAU conditions.

Patients of therapists in the OPM condition will show a greater increase in therapeutic alliance during therapy sessions than patients in the TAU condition.

-Participants and instruments:

Psychotherapy residents and/or Psychotherapists:

180 to 350 will be recruited.

Criteria for inclusion of therapists:

Therapists with a regular

• Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes [Time frame: T2 (up to 6 months) and follow-up (3 months)]
• Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7 [Time frame: Baseline, T2 (up to 6 months), follow up (3 months)]