Routine 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. The 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. 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. ClinicalTrials.gov NCT06356961. Registered on April 10, 2024.
Problematic gaming refers to an excessive pattern of video game use characterized by difficulties in self-regulation and interpersonal functioning. According to attachment theory, insecure attachment may lead individuals to engage in gaming as a coping strategy for emotional distress and unmet relational needs. Although both emotion dysregulation and dissociative experiences have been linked to insecure adult attachment and problematic gaming, the relationships between each of these variables have not yet been tested. This study aimed to investigate whether emotion dysregulation and dissociative experiences mediate the association between insecure adult attachment and problematic gaming among young adult gamers. A total of 692 Italian young adults (68.64
The COVID-19 pandemic amplified an ongoing mental health crisis in Europe. In response, the Italian Ministry of Health introduced the “Psychological Bonus,” a government-funded initiative aimed at improving access to brief psychological interventions (BPIs). This longitudinal study examined the effectiveness of these publicly funded BPIs in reducing psychological distress, anxiety, and depression among a large sample of Italian patients, while also exploring the moderating roles of therapy continuation, therapist orientation, and treatment setting. A total of 1,541 participants were assessed at baseline (T0), post-treatment (T1), and six-month follow-up (T2) using the CORE-10, GAD-7, and PHQ-9. Longitudinal trajectories were analyzed using Linear Mixed Models, controlling for age, sex, and session count. Separate models examined the impact of therapy continuation, therapist orientation, and treatment setting (in-person, online, or blended). Significant reductions in psychological distress, depression, and anxiety from baseline to post-treatment were maintained at follow-up, with effect sizes ranging from medium to large across outcomes and timepoints (d = 0.54–0.80). A small but significant attenuation of psychological distress gains was observed between post-treatment and follow-up, while depression and anxiety scores remained stable. Continuation of therapy after the funded sessions did not significantly moderate symptom trajectories. Likewise, no significant differences in change trajectories emerged across therapist theoretical orientations or treatment settings. The findings provide strong support for the effectiveness of the “Psychological Bonus” as a publicly funded BPI, helpful in addressing widespread mental health needs across different therapeutic and delivery models, representing a promising model for mental health policy.
Abstract BackgroundRoutine outcome monitoring (ROM) is an evidence-based methodology in psychotherapy that supports clinical decision-making through the standardized and systematic collection of patient-reported outcome data. Although its benefits are well established, ROM remains poorly integrated into routine psychotherapeutic practice in many countries, including Italy. Structural fragmentation of services, limited digital infrastructure, and cultural resistance within the profession hinder the adoption of data-informed clinical practices. ObjectiveThis study aims to investigate the implementation of a digital platform designed to support ROM in Italian psychotherapy, with a focus on individual, organizational, and contextual factors influencing adoption and integration into everyday clinical practice. MethodsThis is a longitudinal, mixed methods implementation study embedded within the OutProFeed project, the first randomized controlled trial in Italy focused on ROM in psychotherapy. The study is guided by the Consolidated Framework for Implementation Research, which informed the selection of constructs through a structured expert consensus process. Approximately 30 psychotherapists are included across diverse practice settings, therapeutic orientations, and geographic areas. Data will be collected at three time points (T0 baseline, T1 midimplementation at ~6 mo, and T2 final follow-up at ~12 mo). Qualitative data will be generated through semistructured interviews, while quantitative data will be collected using the Evidence-Based Practice Attitude Scale–36 (EBPAS-36). Qualitative and quantitative data will be linked at the individual level to support integrated interpretation of implementation trajectories. ResultsThe study received ethical approval from the Ethics Committee of the University of Bergamo in April 2024. Technical setup of the digital platform and preimplementation engagement with participating psychotherapists were conducted between May and November 2025. Baseline (T0) implementation data collection started on a rolling basis in December 2025 and is planned to continue through March 2026. The midimplementation follow-up (T1; approximately 6 mo after individual baseline) is expected to occur between June and October 2026, with the final follow-up (T2; approximately 12 mo after baseline) planned between December 2026 and April 2027. Data analysis will begin after completion of follow-up assessments, with initial findings expected to be submitted for publication in 2027. ConclusionsThis protocol outlines a theory-informed and context-sensitive approach to studying the implementation of digitally supported ROM in psychotherapy. By combining qualitative and quantitative data within a longitudinal design, the study aims to generate insights into the conditions under which digital outcome monitoring may be integrated into routine psychotherapeutic work in fragmented and professionally autonomous health care systems.
OBJECTIVE:Few studies have examined whether changes in emotion regulation strategies-cognitive reappraisal (CR) and expressive suppression (ES)-serve as change mechanisms across different psychological treatments. Therefore, we tested whether increases in CR and decreases in ES predict subsequent reductions in client distress and whether these processes are specific to Cognitive Behavioral treatments or represent non-specific mechanisms of change. METHOD:Participants were 1,116 adult outpatients (76.8% female; M = 34.2, SD = 10.8) treated by 947 licensed psychotherapists in the Italian PsyCARE study. Clients completed the Emotion Regulation Questionnaire (Gross & John, 2003), the Patient Health Questionnaire-9, and the Generalized Anxiety Disorder-7 at baseline, session 12, and 6-month follow-up. Polynomial regression and response surface analysis examined whether changes in CR and ES predicted later changes in distress, adjusting for therapist clustering. RESULTS:Increases in CR and decreases in ES significantly predicted subsequent reductions in client distress. Response surface analysis showed that clients who increased CR and decreased ES by an equal amount exhibited the greatest decreases in distress. These effects were not moderated by treatment type, suggesting that CR and ES are non-specific mechanisms of change. CONCLUSION:The findings suggest that improving CR while reducing ES predicts improved outcomes across treatment approach, supporting emotional regulation as a general transdiagnostic mechanism of change.
The present study investigated the indirect effects of adverse childhood experiences (ACEs) on current interpersonal problems through attachment insecurity and expressions of perfectionism. To our knowledge, this is the first study to examine such a serial mediation model and testing development and later maladjustment parts of the Perfectionism Social Disconnection Model [PSDM; Hewitt et al., 2017]. A total of 810 young adults (mean age: 20.46 +/- 2.26 years; range: 18-30 years; 49.4 % females) volunteered for this study. A serial mediation model was tested using path analysis within a structural equation modeling (SEM) framework. In the hypothesized model, ACEs affected interpersonal problems through two serial mediators, namely attachment insecurity (i.e., anxious and avoidant attachment) and expressions of perfectionism (i.e., perfectionistic self-presentation and perfectionistic cognitions). Our results evidenced that ACEs increased interpersonal problems through the serial effects of attachment insecurities and of nondisclosure of imperfections. We also identified a second serial mediation effect, in which ACEs increased interpersonal problems, first passing through attachment anxiety and subsequently through perfectionistic cognitions. These findings highlight the underlying mechanism between ACEs and interpersonal problems by showing that attachment insecurity and perfectionism are key mediators of these associations. Results provide experimental support to a theoretical model (PSDM) and inform the treatment of individuals with a history of ACEs and current interpersonal problems.
Background: The integration of digital tools into psychotherapy has gained increasing attention, particularly for practices such as routine outcome monitoring (ROM), which involves the regular collection of patient-reported data to inform treatment decisions. However, despite the potential benefits, the adoption of digital platforms remains limited, partly due to usability concerns and workflow misalignment. Objective: This study aimed to assess the usability of a digital platform, Mindy, designed to support psychotherapists in implementing ROM and to explore broader challenges associated with the integration of digital tools into psychotherapeutic practice. Methods: This study adopted a qualitative, 2-stage approach. Sixteen psychotherapists participated in semistructured interviews, which included task-based usability testing and reflective discussions. Participants interacted with Mindy by performing typical clinical tasks, such as creating patient profiles, managing session data, and sending questionnaires. The first stage of analysis used a deductive thematic approach focused on predefined platform functionalities. The second stage followed an inductive methodology to identify broader themes related to the integration of digital tools in psychotherapy. Results: The usability assessment identified strengths in the platform's appointment scheduling, questionnaire delivery, and dashboard functionalities, which were perceived as intuitive and supportive of ROM practices. However, limitations were reported in areas such as documentation flexibility, interoperability with other systems, and control over information sharing with patients. Broader thematic analysis revealed three main challenges: (1) the tension between standardized documentation and the need for narrative and implicit information; (2) difficulties in embedding digital platforms into existing therapeutic workflows, especially for clinicians less familiar with technology; and (3) concerns about confidentiality and the potential for misinterpretation when sharing therapeutic notes with patients. Conclusions: These findings underscore the importance of considering both technical and contextual dimensions when developing and implementing digital platforms in mental health care. Tailoring digital tools to the needs and practices of psychotherapists may improve adoption and ultimately enhance the quality of care.
Mental health disorders and limited care access are global challenges. In Italy, the Psychological Bonus (PB) aims to increase access to psychological care. As part of the PsyCARE project, this study explores the characteristics of the PB's participants, using a person-centered approach to investigate patients' psychopathological and transdiagnostic profiles. Cross-sectional data from 2261 patients were analyzed, focusing on clinical characteristics, treatment reasons, and differences between patients already in therapy and new patients. Latent Profile Analysis (LPA) identified psychological profiles based on symptoms and transdiagnostic factors (emotion regulation and epistemic trust). Anxiety and depressive disorders were the most common diagnoses. Patients already in treatment were more likely to be on medication, have a history of non-suicidal self-injury, and have experienced hospitalization for psychological problems. LPA identified four profiles: Profile 1 (19.79 %) with the highest distress, poor emotion regulation, and significant interpersonal difficulties; Profile 2 (28.89 %) and Profile 3 (22.82 %) with above-average distress but varying emotion regulation behaviors and interpersonal dispositions; and Profile 4 (28.50 %) with the lowest distress, adaptive emotion regulation, and more adaptive interpersonal dispositions. Significant Sex and age differences were observed across profiles, but no differences between patients already in therapy and new patients. This study emphasizes the value of integrating transdiagnostic elements into psychological assessment beyond symptom-focused approaches. While different profiles presented similar levels of psychological distress, they differed substantially in emotion regulation strategies and interpersonal dispositions. These findings underscore the need for tailored interventions addressing symptomatology and the transdiagnostic mechanisms that shape individuals' psychological functioning.
OBJECTIVE:This study aimed to translate the Rupture Resolution Rating System (3RS) and the Working Alliance Inventory -Observer Short Form (WAI-O-S) into Italian. As a preliminary step toward validation, inter-rater reliability and convergent validity of the translated measures were also examined. METHOD:First, forward-backward translation process was conducted to ensure conceptual and linguistic equivalence with the original English versions. Second, four trained raters independently applied the Italian versions of the 3RS and WAI-O-S to 47 psychotherapy sessions involving 20 different patients. Finally, inter-rater reliability (IRR) and convergent validity were analyzed. RESULTS:This study produced the first Italian versions of the 3RS and WAI-O-S, providing conceptually robust tools to assess therapeutic alliance and rupture-repair processes. Preliminary analyses showed acceptable inter-rater reliability for both measures, though some variability emerged in certain 3RS dimensions-particularly Therapist Withdrawal and Repair. Strong correlations between the 3RS Working Together score and the WAI-O-S total score offered preliminary evidence of convergent validity. CONCLUSION:These preliminary findings provide initial support for the reliability and validity of the Italian 3RS and WAI-O-S. Further studies in larger and more diverse samples are necessary to examine their generalizability and clarify their applicability.
There is increasing evidence that psychotherapy efficacy can be enhanced by accommodating clients’ preferences regarding their role, the treatment, and the therapist. Several instruments are available to measure these concepts, although only the Cooper-Norcross Inventory of Preferences (C-NIP) appears particularly suitable for psychotherapy. This study aimed to validate the Italian version of the C-NIP and to provide norms for both clinical and research use for Italian-speaking individuals. We adopted a multi-step procedure to translate the C-NIP into Italian. Then, 1084 (70.3
Background: Routine outcome monitoring with immediate clinical feedback can improve the effectiveness of psychotherapy. This protocol study represents the first Italian randomized controlled trial (RCT) to evaluate the effectiveness of Feedback Informed Therapy (FIT) to improve patient mental health outcomes and processes. In it, we test a state-of-the-art digital platform (named Mindy) designed and developed for therapists that includes an integrated monitoring and support system. Methods: This longitudinal RCT (Zellen design) involves randomizing therapists and their patients who meet the inclusion criteria into three conditions. The first condition involves outcome and process monitoring (OPM). In this condition, patients complete outcome and process measures related to each psychotherapy session, therapists use the Mindy platform to monitor the outcome and process measures, but therapists do not receive feedback with clinical support tools. The second condition involves outcome and process monitoring plus feedback (OPM-F). In this condition patients complete outcome and process measures related to each session and therapists receive feedback on the Mindy platform’s Clinical Support Tools based on the principles of feedback-informed therapy (FIT). Therapists in the OPM-F condition also receive monthly supervision/coaching for three months aimed at enhancing their use of the Clinical Support Tools. The third condition is treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would, and therapists do not receive training. Therapists only use the Mindy platform as a streamlined digital record and to fill out the process evaluations at pre-treatment (after the first session) and the last study session (15th session) but without access to the data. In addition, therapists and patients in all conditions complete outcome questionnaires at pre-treatment, post-treatment and follow-up. Discussion: We expect that compared to the other conditions, patients treated by therapists in the OPM-F condition will experience greater reductions in symptoms, lower dropout rates, and a better therapeutic alliance. Therapists in the OPM-F condition will demonstrate better management of therapeutic alliance ruptures. Overall, the results of this study could encourage future decisions on the use of digital platforms (e.g., Mindy) and FIT. Study registration: April 10, 2024 [https://clinicaltrials.gov/study/NCT06356961]
Previous research has highlighted the positive impact of greater health-related quality of life (Hr-QoL) and subjective well-being (SWB) on chronic diseases’ severity and progression. There is a paucity of studies investigating the long-term trajectories of these variables among hypertensive patients. The present study aims to investigate the relationships between psychological variables (Type A and D personality, locus of control—LoC, self-esteem, and trait anxiety) with SWB and Hr-QoL in patients with hypertension and comorbid metabolic syndrome. A total of 185 volunteer patients (130 males, 70.3%; mean age 54 ± 10.93) were enrolled. Patients filled out measures of Hr-QoL and SWB, LoC, and self-esteem at three time points—Type A and D behaviors and anxiety measures only at baseline. Analyses were run through two-level hierarchical mixed models with repeated measures (Level 1) nested within participants (Level 2), controlling for sociodemographic and clinical confounders. Neither Hr-QoL nor SWB changed over time. Patients with greater self-esteem and internal LoC (and lower external LoC) increased their SWB and Hr-QoL up to 1-year follow-up. A greater Type A behavior and trait anxiety at baseline predicted a longitudinal increase in most of the dependent variables. Results suggest that it could be useful to tailor interventions targeting specific variables to increase Hr-QoL and SWB among hypertensive patients.
Prophylactic Bilateral Salpingo-Oophorectomy (PBSO) may be associated with body image distress (BID). However, the risk factors of BID after PBSO and its sexual and relational consequences are still largely understudied. This study aimed at investigating 1) the frequency of BID after PBSO; 2) the role of previous medical treatments for breast cancer and age on BID; and 3) the mediating role of couple satisfaction on the relationship between BID and sexual distress. Fifty-nine women (Mage: 50.64 ± 6.7 years) who underwent PBSO took part in this cross-sectional study, filling out a sociodemographic and clinical questionnaire, and self-report measures of body image, sexual distress and couple satisfaction. Statistical analyses included the Kruskal–Wallis test and a mediation model. One third (33.9
The disorders of gut–brain interaction (DGBIs) are a heterogeneous group of chronic conditions that greatly reduce patients’ quality of life (QoL). To date, biopsychosocial factors (such as gastrointestinal symptoms, alexithymia, and interpersonal problems) are believed to contribute to the development and maintenance of DGBIs, but their role in affecting patients’ QoL is still under investigation. Out of 141 patients seeking treatment for their gastrointestinal symptoms, 71 were diagnosed with a DGBI (47 females, 66.2%; Mage: 41.49 ± 17.23 years) and were age- and sex-matched to 71 healthy controls (47 females, 66.2%; Mage: 40.45 ± 16.38 years) without any current gastrointestinal symptom or diagnosis. Participants completed a sociodemographic and clinical questionnaire and a survey investigating several psychosocial risk factors. We found greater symptom severity and difficulties in identifying feelings among patients compared to controls. Further, multiple linear regression analyses evidenced that, among patients, higher expressive suppression of emotions, difficulties in identifying feelings and interpersonal problems, and a lower cognitive reappraisal of emotions predicted lower QoL. Data suggest that the QoL of patients with DGBIs is affected not only by common risk factors (e.g., interpersonal problems) but also by specific difficulties in processing and regulating emotions. The implications of these findings are discussed.
We face increasing demand for greater access to effective routine mental health services, including telehealth. However, treatment outcomes in routine clinical practice are only about half the size of those reported in controlled trials. Progress feedback, defined as the ongoing monitoring of patients’ treatment response with standardized measures, is an evidence-based practice that continues to be under-utilized in routine care. The aim of the current review is to provide a summary of the current evidence base for the use of progress feedback, its mechanisms of action and considerations for successful implementation. We reviewed ten available meta-analyses, which report small to medium overall effect sizes. The results suggest that adding feedback to a wide range of psychological and psychiatric interventions (ranging from primary care to hospitalization and crisis care) tends to enhance the effectiveness of these interventions. The strongest evidence is for patients with common mental health problems compared to those with very severe disorders. Effect sizes for not-on-track cases, a subgroup of cases that are not progressing well, are found to be somewhat stronger, especially when clinical support tools are added to the feedback. Systematic reviews and recent studies suggest potential mechanisms of action for progress feedback include focusing the clinician’s attention, altering clinician expectations, providing new information, and enhancing patient-centered communication. Promising approaches to strengthen progress feedback interventions include advanced systems with signaling technology, clinical problem-solving tools, and a broader spectrum of outcome and progress measures. An overview of methodological and implementation challenges is provided, as well as suggestions for addressing these issues in future studies. We conclude that while feedback has modest effects, it is a small and affordable intervention that can potentially improve outcomes in psychological interventions. Further research into mechanisms of action and effective implementation strategies is needed.
ObjectiveAn individual's attachment style may impact how they interact with their therapy group. This study examined the moderating role of a group member's attachment on the dynamic relationships between that group member's (actor) and other group members' (partner) therapeutic alliances and symptom outcomes. Method: This is a secondary analysis of data from a trial testing the outcome of emotionally-focused group therapy for binge-eating disorder. The sample consisted of 2,360 sessions nested within 118 group members who attended a 20-session treatment. Patients recorded binge eating episodes (BEE), their body weight and an alliance measure session-by-session.ResultsDynamic structural equation modelling showed decreases in BEE and weight over the therapy. When attachment style was not included in the model, higher-than-average partner's alliance scores in the previous session were related to decreases in BEE in the current session. Attachment style moderated these actor and partner effects. For patients with preoccupied attachments, higher-than-average actor alliance in the previous session was related to subsequent decreases in BEE. For patients with dismissing or disorganized attachments, higher partner alliance in the previous session was related to subsequent decreases in BEE.ConclusionGroup members' attachment characteristics can play a role in the development of alliance-outcome patterns in group therapy.