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

Access to Technology-Mediated Community Mental Health Care Among Low-Socioeconomic Status Consumers With Serious Mental Illness: Qualitative Study

Background: Access to mental health care is critical for the effective management of serious mental illness (SMI), but consumers with low socioeconomic status (SES) have lower rates of service usage and worse retention in care. Digital technologies are often lauded as a way to bridge access gaps; however, little is known about how technology-mediated care may influence care access among low-SES consumers and how consumers use technology in care access. Objective: This study aimed to examine the applicability of Levesque et al’s access framework to technology-mediated care for SMI and analyze how low-SES consumers use technology to facilitate care access. Furthermore, the study assesses whether and how technologies are involved in care access at multiple points within the process of accessing care. Methods: This study used 2 qualitative methods: ethnographic observations at a mental health treatment court and interviews with low-SES consumers with SMI using community mental health care (n=14) and key informant interviews with health and service providers working with this population (n=14). Observations occurred from July 2022 through September 2023, and interviews occurred between January 2022 and May 2024. Data analysis involved both inductive and deductive coding approaches. Data from both the interviews and observations were analyzed in NVivo and further triangulated through analytic memos. Results: Levesque et al’s framework required several extensions to accommodate technology-mediated care related to SMI for low-SES consumers: (1) a cyclical rather than linear trajectory; (2) simultaneous care acquisition from multiple health and service providers; (3) staying in care long-term; (4) identification of both one-time and ongoing health needs; and (5) an emergency pathway for entering care. Consumers often faced challenges related to the varied digital requirements of each provider and a dearth of integrative, patient-facing tools like portals. Within this context, some consumers use mobile apps, communication, and telehealth technologies across various care access stages. Consumers used technology by figuring out how to navigate technology-mediated care, especially by leaning on others, such as case managers, for support. These others provided consumers with temporary technologies, showed them how to use technologies, and accompanied them through the process of using technology for accessing care. Conclusions: This study highlights that accessing care is iterative and ongoing, involving multiple forms of co-occurring service provision. A theoretical contribution of this work is its extension of Levesque et al’s care access framework to better reflect technology-mediated care for SMI among low-SES consumers. This work also underscores ongoing challenges for accessing technology-mediated care and the importance of human support in addressing access difficulties. Clinical implications include incorporating digital readiness assessments and providing comprehensive guidance on how consumers can effectively use technologies for care. Future work should investigate how technology-mediated care can make care access easier rather than harder.
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Opportunities for Digital Health to Support Early Psychosis Care in Ghana: Qualitative Study Among Patients, Caregivers, and Clinicians

Background: Youth experiencing early psychosis in West Africa often face delays in accessing evidence-based treatment. Digital mental health interventions may offer an acceptable and scalable approach to improve access to early psychosis care in West Africa; however, few data exist on the experiences and perspectives of patients with early psychosis and their caregivers to inform digital intervention development. Objective: This study aims to explore current experiences of early psychosis care, identify barriers and facilitators to in-person early psychosis care within health facilities, and identify opportunities for digital interventions to support patients with early psychosis and caregivers in Ghana. Methods: We conducted qualitative focus group discussions among patients with early psychosis, their caregivers, and their mental health care providers recruited at Accra Psychiatric Hospital in Accra, Ghana. Trained qualitative researchers facilitated discussions using a structured qualitative interview guide, exploring current care practices for early psychosis in Ghana, barriers and facilitators to facility-based care, and perceptions of digital mental health interventions. Transcripts were translated, transcribed, and analyzed thematically using a hybrid inductive and deductive approach grounded in the theoretical framework of acceptability. Results: Overall, we conducted 4 focus group discussions (N=31) among 7 patients with early psychosis (median age 28, IQR 21‐41 years), 6 caregivers (median age 58, IQR 29‐34 years), and 18 clinicians (median age 30, IQR 29‐34 years). Participants described current early psychosis care practices in Ghana, including seeking spiritual and traditional healing, the dearth of information and resources about psychosis, and the integral role of caregivers in facilitating treatment engagement and continuation (often at the cost of caregiver mental distress and burnout). Common barriers to facility-based mental health care included stigma associated with mental illness, lack of prior knowledge about early psychosis and treatment options, and practical constraints (eg, financial, logistical, and health care system limitations). Motivating factors for facility-based care included success stories from community members and strong rapport and trust in mental health clinicians. Technology (eg, mobile phones, laptops, radio, and television) was commonly used among participants in typical daily tasks, health information seeking, and stress reduction. Participants expressed support for digital tools that could deliver psychoeducation about early psychosis, support treatment adherence, and extend patient-provider communication between clinic visits. Conclusions: Digital mental health interventions have the potential to complement facility-based early psychosis services in Ghana by addressing misinformation, reducing access barriers, and supporting caregiver roles. These qualitative findings inform potential integration points, content, attributes, and strengths of digital modalities that could be leveraged to support patients with early psychosis and their caregivers in Ghana.
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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
<![CDATA[Learn more about how sex hormones and prolactin shape brain circuits, revealing new biomarkers and treatment strategies for eating disorders, psychosis, and depression.]]>

Altered static and dynamic regional homogeneity in basal ganglia–thalamocortical circuits and their association with neuropsychiatric manifestations in Wilson’s disease

PurposeWilson’s disease (WD) is an autosomal recessive disorder caused by ATP7B mutations, resulting in impaired copper metabolism and progressive neuropsychiatric manifestations. This study investigated spatiotemporal alterations in regional brain activity using static and dynamic resting-state fMRI with regional homogeneity (ReHo), and their relationships with clinical features.MethodsResting-state fMRI data were acquired from WD patients and healthy controls (HCs). Static and dynamic ReHo analyses were performed to characterize local synchronization strength and temporal variability of spontaneous neural activity. Group differences were assessed across the basal ganglia, thalamus, cerebellum, and cortical regions. Associations between altered ReHo metrics and clinical measures were evaluated with FDR correction for multiple comparisons.ResultsCompared with HCs, WD patients exhibited widespread ReHo abnormalities involving the basal ganglia (putamen and globus pallidus), thalamus, cerebellum, and cortical regions. Static ReHo in the left putamen and globus pallidus was positively associated with anxiety severity, while right putaminal ReHo was negatively associated with neurological severity and positively associated with disease duration. Dynamic ReHo in the left middle frontal gyrus showed negative associations with depression severity and disease duration. All brain–behavior correlations survived FDR correction, indicating robust effects.ConclusionWD is characterized by disrupted spatiotemporal organization of local functional synchronization within cerebellar and basal ganglia–thalamo–cortical circuits. These findings support a network-level dysfunction model involving subcortical synchronization deficits and cortical temporal instability, which together underpin neuropsychiatric manifestations and disease progression.

Machine learning for oral frailty factors in hospitalized schizophrenia patients: two-stage feature selection and SHAP analysis

BackgroundLong-term hospitalized patients with schizophrenia (SZ) often experience significant oral health problems, and oral frailty (OF) can further exacerbate the decline in their quality of life. However, the status and key influencing factors contributing to OF in this population remain insufficiently explored. Most existing studies rely on traditional regression models, which are prone to overfitting when processing high-dimensional data, making accurate risk identification difficult. This study aims to clarify the current status of OF in this population in Southwest China, identify the influencing factors, and optimize the predictive model using machine learning (ML), thereby providing a basis for clinical practice.MethodsA total of 404 long-term hospitalized patients with SZ from three psychiatric hospitals in Southwest China were enrolled in this study. The Oral Frailty Index-8 was employed to assess OF. Nine feature selection methods and five ML models were employed to optimize the model through two-stage feature selection, while Shapley Additive Explanations (SHAP) were used to analyze the model’s predictive logic.ResultsThe prevalence of OF in this population was determined to be 69.3%. The optimal model identified was the random forest, with the Area Under the Curve increasing to 0.779 following two-stage optimization. Compared to non-feature selection, performance improved by approximately 6.57%. SHAP analysis revealed that the Number of Teeth, Number of Psychiatric Hospitalizations, Self-discontinuation of Medication, Marital Status, and Age were core risk factors for OF.ConclusionThe prevalence of OF in long-term hospitalized patients with SZ is notably high. Two-stage feature selection enhances the accuracy of the predictive model, and the identified core factors can serve as a reference for developing individualized oral intervention programs in clinical practice.

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.