Clinical Research Directory

Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale

Patients with severe acquired brain injury (sABI) and disorders of consciousness (DoC) require intensive interdisciplinary rehabilitation involving healthcare professionals, patients, and family caregivers. Caregivers play a key role in supporting patients and ensuring continuity of care, yet they frequently experience high levels of psychological distress, anxiety, depression, caregiver burden, and reduced quality of life. Previous studies have highlighted the need for clearer communication and greater caregiver involvement throughout the rehabilitation process. The Social and Family Evaluation (SAFE) scale was developed to actively involve caregivers in monitoring patients with DoC. Derived from the Coma Recovery Scale-Revised (CRS-R), SAFE is a simplified, caregiver-friendly observational tool that enables family members to report clinically relevant behaviors observed during daily interactions. Preliminary validation demonstrated excellent psychometric properties, including high internal consistency, excellent test-retest reliability, and good criterion validity compared with the CRS-R. However, its effectiveness has not yet been investigated in the subacute rehabilitation setting. The primary aim of this study is to evaluate whether the use of the SAFE scale improves caregivers' illness perceptions. Secondary objectives are to assess its impact on caregiver satisfaction with rehabilitation, decisional conflict, anxiety, depression, prolonged grief, and caregiver burden. This is a non-profit, prospective, multicenter, single-blind randomized controlled trial involving 68 caregiver-patient dyads recruited from three intensive neurorehabilitation units of the Don Carlo Gnocchi Foundation in Florence, Milan, and Sant'Angelo dei Lombardi (Italy). Adult caregivers of patients with DoC admitted within three months after brain injury will be randomly assigned (1:1) to either the SAFE intervention group or a standard-care control group. Randomization will be stratified according to caregiver relationship (parent vs. non-parent) and patient diagnosis (vegetative state/unresponsive wakefulness syndrome vs. other DoC). At baseline (T0), caregivers will complete the Brief Illness Perception Questionnaire (BIPQ), Family Strain Questionnaire (FSQ), Prolonged Grief Disorder-12 (PG-12), Beck Depression Inventory-II (BDI-II), and State-Trait Anxiety Inventory (STAI-Y). Patients will be assessed using the Coma Recovery Scale-Revised (CRS-R) and the Level of Cognitive Functioning (LCF). Caregivers allocated to the SAFE group will receive standardized training on the SAFE scale and complete it at 2 weeks (T1) and 6 weeks (T2), together with repeated BIPQ assessments. Control participants will receive routine clinical care and complete the BIPQ only. Both groups will receive the same psychoeducational booklet as standard care. At the final follow-up (T3, 10 weeks after enrollment), caregivers will repeat all baseline assessments and additionally complete the Family Satisfaction in Intensive Care Unit (FS-ICU) and the Decisional Conflict Scale (DCS). Patients will undergo repeat CRS-R and LCF assessments together with the Glasgow Outcome Scale-Extended (GOSE). The primary endpoint is the BIPQ Illness Coherence score at T2. The primary analysis will use ANCOVA adjusted for baseline values. Based on preliminary data, 68 caregivers will be enrolled to detect a clinically meaningful difference between groups while accounting for an expected 20% dropout rate. A blinded sample-size re-estimation will be performed after recruitment of the first 30 participants. Secondary analyses will evaluate the effects of the SAFE intervention on caregiver burden, prolonged grief, anxiety, depression, family satisfaction, and decisional conflict using adjusted statistical models. The study is considered low risk, as all procedures are consistent with routine clinical practice. If effective, the SAFE scale may enhance caregiver understanding of the patient's condition, improve communication with the rehabilitation team, promote shared decision-making, reduce psychological distress, and support a more family-centered approach to neurorehabilitation.

AI Ambient Scribe in Psychiatry

The goal of this clinical trial is to learn if an artificial intelligence (AI) tool that listens to appointments and drafts clinical notes can help clinicians in psychiatric care. Researchers also want to know if the tool changes how patients experience their care. The study includes mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) at Psychiatrie St. Gallen and the adult patients they see in their appointments. The main questions it aims to answer are: * Does the AI tool lower the time clinicians spend writing notes? * Are notes written with the AI tool as good as or better than notes written without it? * Do patients notice a difference in their relationship with their clinician when the tool is used? Researchers will compare clinicians who use the AI tool to clinicians who keep writing notes their usual way, before and during the intervention period, to see if writing time, note quality, and the patient-rated therapeutic relationship differ between the two groups. Clinicians will: Join one of two groups. One group starts using the AI tool on August 17, 2026 (7 clinicians whose devices were delivered late start on November 9, 2026). The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026 (the 7 late-starting clinicians and additional control data collection until February 22, 2027), with note quality evaluation in February and March 2027. Clinicians who cannot contribute to all measurements may, with their consent, remain in the study for automated measurement of documentation time only. Patients will: \- Be invited to fill out a short, anonymous survey about their experience with their clinician.

Therapeutic Alliance Tensions and Repair in Psychotherapy Practices

This study evaluates a professional development program intended to improve the relationship or alliance between therapists and patients/clients who are receiving psychotherapy in the community. Half of the participating therapists will receive training to detect and improve alliance with new patients while half will not. The professional development training is expected to improve therapists effectiveness in identifying and correcting alliance tensions which will, in turn, improve therapeutic outcomes for patients/clients.

Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.

This study evaluates the effectiveness of a 3-month video-based lifestyle intervention, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with type 2 diabetes mellitus (DM2). Participants will be randomly allocated to receive the intervention either delivered by their own physician (experimental group) or by a physician unknown to them (control group). Assessment will include sociodemographic variables, glycated hemoglobin / HbA1c (primary outcome), body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to HbA1c, therapeutic alliance, age, and sex.

Evaluation of the Impact of Participation in a Psycho-education Program for Victims of Sexual Violence

Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients.

Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth

Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance use, school failure, and later recidivism. Despite available treatments, managing emotional dysregulation in custody remains challenging, with youth often enduring high arousal, anger, and anxiety that persist into adulthood. Current popular therapies, including Cognitive Behavioral Therapy (CBT) and Dialectic Behavioral Therapy (DBT), often fall short in detention because they rely on verbal processing, require multiple scheduled sessions, and/or need highly trained staff. Other technologies, like biofeedback and neurostimulation techniques, are still under scrutiny for adolescents, given their higher-than-usual Adverse Events (AEs). This SoundHeal study aims to evaluate a sensory intervention using the Healpod, a distraction-free physical space where a participant sits, delivering sound, music, gentle vibrations, and ambient light. Following this is a brief expressive journaling exercise to compare any before, during and after experience changes from the sensory immersion. This prospective, single-center cohort study hypothesizes that these sessions will improve juveniles' ability to emotionally regulate, improve therapeutic alliance, mental health outcomes and build coping skills that can potentially help in long-term mental health and substance abuse treatment in JIY and beyond.