Tag: Clinical trial

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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
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MDMA Assisted Therapy for BN

Conditions: Bulimia Nervosa

Interventions: Drug: MDMA-AT; Drug: MDMA-AT-BN; Behavioral: Standard Treatment (ST)

Sponsors: Icahn School of Medicine at Mount Sinai

Not yet recruiting
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Popular Online Content as a Treatment-as-Usual Control in Digital Mental Health Intervention Trials: Secondary Analysis of Two Online Randomized Controlled Trials With Repeated Measures

Background: Treatment-as-usual (TAU) conditions are intended to reflect the support typically received in routine treatment settings. For digital mental health interventions (DMHIs) delivered online, TAU conditions should reflect the usual patterns of online help-seeking. The lack of ecologically valid TAU control conditions has been a gap in effectiveness trials of online DMHIs. In this study, mental health–related popular online content (eg, advice TikToks, lived experience vlogs, and self-care infographics) was examined as a valuable TAU control condition. Objective: This study examined the feasibility of popular online content as a TAU control condition in DMHI trials. Methods: This study was a secondary analysis of two randomized controlled trials. Both trials recruited participants online, primarily via an online study recruitment platform. In study 1 (N=916), US adults with elevated depression or anxiety were randomized to either (1) complete a single-session DHMI for depression and anxiety (n=291), (2) search the web for popular online content relevant to their struggles (n=312), or (3) search a curated library of mental health–related popular online content (n=313). In study 2 (N=431), US adults with elevated loneliness were randomized to (1) complete a single-session DHMI for loneliness (n=136), (2) search a curated library of popular online content related to loneliness (n=145), or (3) complete an attention-matched control condition (n=150). All 6 programs took approximately 10 to 20 minutes to complete and were entirely self-guided. Participants rated each program’s credibility and expected benefit, as well as their feelings of distress (study 1) and loneliness (study 2). The studies did not involve interaction between participants and the research team. Results: In study 1, dropout during the treatment was 4.8% (14/291) for the single-session intervention, 25.9% (81/312) for online help-seeking, and 9.6% (30/313) for the curated library. The curated library’s credibility and expected benefit score did not differ from that of the single-session intervention (Cohen =0.08; =.88) and was higher than that of unguided help-seeking (Cohen =0.23; =.01). In study 2, dropout was higher in the curated library condition (7/145, 4.8%) than in the single-session intervention and the attention-matched control condition (0/136, 0.0% and 0/150, 0.0%). The mean credibility and expected benefit score for the curated library was comparable to that of the attention-matched control condition (Cohen =0.00; >.99) but lower than that of the single-session intervention (Cohen =0.32; =.02). Changes in distress and loneliness from baseline to 8-week follow-up did not differ across the conditions in study 1. All effect sizes were small in study 1 (Cohen <0.15 and no comparisons were statistically significant >.06). Similarly, in study 2, all effect sizes were small (Cohen <0.12), and no comparisons were statistically significant (>.25). Conclusions: Curated libraries of popular online content are a feasible, ecologically valid TAU benchmark for effectiveness trials of online DMHIs. Future research on TAU conditions in online help-seeking contexts should better align with observed DMHI attrition rates and account for the increasingly central role of conversational artificial intelligence in online mental health support. Trial Registration: OSF Registries 3DYMA; https://osf.io/3dyma and NVD79; https://osf.io/nvd79; ClinicalTrials.gov NCT05687162; https://clinicaltrials.gov/study/NCT05687162
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Postmarketing surveillance of elobixibat for patients with chronic constipation and concomitant schizophrenia or depression in Japan

BackgroundLittle is known about the optimal treatment for constipation in patients with schizophrenia or depression. Elobixibat is a laxative with a novel mechanism of action that inhibits the ileal bile acid transporter, acting as both an osmotic and a stimulant agent.MethodsWe conducted a prospective, multicenter, postmarketing surveillance study to assess the safety and effectiveness of elobixibat for patients with chronic constipation in Japan (jRCT1080223950). The surveillance period was between June 2018 and May 2022. Patients were observed from the date of initial administration of elobixibat to 55 days thereafter (4-week treatment groups) or to 419 days thereafter (52-week treatment groups). Safety outcomes included adverse drug reactions (ADRs). Effectiveness outcomes included defecation frequency, Bristol Stool Form Scale (BSFS) scores, and constipation-related symptoms.ResultsIn the safety analysis set, the 4-week treatment groups comprised 105 patients with schizophrenia and 129 with depression; the 52-week treatment groups included 43 patients with schizophrenia and 55 with depression. Approximately 85% to 95% of patients used antipsychotics, and 40% to 55% used anxiolytics or sedative-hypnotics. The proportions of patients who experienced ADRs were 4.76% in the 4-week treatment group and 2.33% in the 52-week treatment group of patients with schizophrenia, and 3.88% and 9.09% of patients with depression. Diarrhea was the most common ADR in each group. There were no serious ADRs. In the 4-week treatment groups, the mean defecation frequency per week at baseline was 3.3 among patients with schizophrenia and 3.0 among patients with depression, which increased to 5.3 and 4.9, respectively, at week 4. In the 52-week treatment groups, the mean defecation frequency per week at week 52 was higher than that at baseline. After treatment, the proportion of patients with an ideal BSFS score of 4 increased in all groups by week 2 and reached approximately 60% by week 52. All constipation-related symptoms also improved by week 2 in all groups.ConclusionsElobixibat improved chronic constipation with no new safety signal identified in patients with schizophrenia or depression and with available follow-up in real-world settings.Clinical trial registrationhttps://jrct.mhlw.go.jp/latest-detail/jRCT1080223950, identifier jRCT1080223950.