Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

Conditions: Self-compassion Training (SCT) Plus Intranasal Oxytocin; Self-compassion Training (SCT) Plus Intranasal Placebo

Interventions: Drug: Intranasal Oxytocin (IN-OXT); Drug: Intranasal Placebo; Behavioral: Self-Compassion Training (SCT)

Sponsors: Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau

Recruiting

Expected Competencies and Personal Attributes of Digital Health Navigators to Support Digital Mental Health Care: Focus Group and Interview Study With Patients and Health Care Professionals

Background: Digital mental health apps (DMHAs), and in particular digital therapeutics (DTx), offer promising opportunities to support mental health care. However, their effective use in outpatient settings in Germany remains limited. To overcome this gap, the role of digital health navigators (DHNs) has been introduced. DHNs are trained individuals who support patients and health care professionals in selecting, using, and integrating DMHAs into care. Despite increasing interest in this role, there is limited evidence on the competencies, knowledge, and personal attributes required for DHNs to work effectively in mental health settings. Objective: The study aims to explore the expected competencies, knowledge areas, and personal attributes that DHNs need to effectively support the implementation and use of DTx in outpatient mental health care. Methods: As part of the prestudy of the Digital Navigators for Acceptance and Competence Development with Mental Health Apps (DigiNavi) study, a qualitative study was conducted involving 35 participants (7 general practitioners, 8 patients in general practice, 11 outpatient psychiatrists/psychologists, and 9 patients in psychiatric outpatient clinics) from different general practices and psychiatric outpatient clinics in Germany. A total of 17 semistructured interviews and 4 focus groups were conducted to explore expectations of DHNs. Data were analyzed using qualitative content analysis. Results: Participants emphasized that DHNs should combine strong interpersonal skills (empathy, patience, and sensitive communication) with technical and basic clinical competencies. Most favored DHNs as integrated clinical team members (eg, medical assistants), citing their existing patient relationships, but noted time and training constraints. Key expectations included the ability to support patients with DTx use, adapt communication to individual needs, and convey data privacy information clearly. Foundational knowledge of mental health conditions and sensitivity to crises were considered important for identifying warning signs and escalating concerns. While DHNs were seen as essential intermediaries between patients, health care professionals, and DTx, participants highlighted the necessity for clearly defined roles, structured training, and realistic expectations to prevent role overload and enable sustainable implementation in outpatient mental health care. Conclusions: DHNs require a specialized skill set that bridges clinical understanding, digital expertise, and interpersonal competence. Our results lay the groundwork for developing training curricula and implementation strategies that align with real-world expectations for the DHN role. Defining these core competencies is essential for supporting the sustainable and effective integration of DMHAs into mental health care. Trial Registration: German Clinical Trials Register DRKS00034327; https://drks.de/search/en/trial/DRKS00034327 and ClinicalTrials.gov NCT06575582; https://clinicaltrials.gov/study/NCT06575582 International Registered Report Identifier (IRRID): RR2-10.2196/67655
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Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.

Conditions: Autism Spectrum Disorder; Autism

Interventions: Procedure: Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells; Dietary Supplement: Fecal Biomicrome Transplantation (FMT); Dietary Supplement: Ketogenic RESET Diet Protocol; Behavioral: Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients; Dietary Supplement: FMT (Fecal Material Tranplantation); Biological: Use autologous cSVF + MSCs (cryo) for management of autoimmune component, anti-inflammatory and immune modulation

Sponsors: Black Tie Medical, Inc.

Enrolling by invitation