Tag: Clinical trial

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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.
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ADOLESCENTS IMAGING USING fMRI: Feasibility Study

Conditions: Diagnosis of BPD Based on the DIB-R Clinical Interview for the BPD Group; Diagnosis of ADHD Using the KSADS-PL for the ADHD Group; Absence of Pathology on the CBCL and Ab-DIB for the Healthy Control Group; All Participants Were Euthymic at the Time of Task Administration

Interventions: Diagnostic Test: functional magnetic resonance imaging (fMRI)

Sponsors: Etablissement Public de la Sante Mentale de la Somme; Centre Hospitalier Universitaire, Amiens

Recruiting
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Impact of Prescribed and Self-Selected Music Interventions on Stress, Sleep, Heart Rate Variability, and Brain Connectivity in Surgeons Using 7-Tesla Functional Magnetic Resonance Imaging and Wearable Actigraphy: Multimodal Feasibility Randomized Controlled Trial

<strong>Background:</strong> Stress, sleep deprivation, and burnout are significant safety risks for acute care surgeons, negatively impacting performance, well-being, and clinical outcomes. <strong>Objective:</strong> This pilot randomized controlled trial aimed to measure neurophysiological effects of prescribed music (PM) and self-selected music (SSM) on surgeon stress, burnout, and neurophysiological responses using a multimodal protocol that integrated functional magnetic resonance imaging (fMRI), wearable biosensor monitoring, and psychological self-assessments. <strong>Methods:</strong> Full-time attending surgeons at a quaternary care hospital were invited to participate in a 3-armed trial (1:1:1 block allocation). Intervention groups were instructed to listen to 30 minutes (minimum 15 minutes) of either PM or SSM daily at bedtime for 6 weeks, reflecting real-world conditions. PM comprised original compositions based on elements promoting perceived relaxation from a prior study. The control arm avoided music in the 30 minutes before bed. Allocation was concealed from the recruiting investigator; the fMRI technicians, the statistician, and lead investigators were blinded until analyses were completed. Functional connectivity patterns were measured using fMRI at baseline and 6 weeks while participants listened to simulated intensive care unit noise, PM, and SSM. Secondary outcomes included continuous actigraphy for sleep quality and self-reported anxiety, sleep quality, and burnout using validated scales (State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, and Maslach Burnout Inventory). <strong>Results:</strong> A total of 22 surgeons were assessed; demands of fMRI and data collection schedule led 3 to decline and 2 (allocated to PM) not to finish baseline measures; 6 PM, 5 SSM, and 6 controls received allocated intervention; 2 PM participants were withdrawn for nonadherence and missing follow-up data and 1 control missed follow-up collection due to scheduling (final analysis set after missing data: PM: n=4, SSM: n=5, control: n=5). One control participant experienced transient vertigo in fMRI. Trends in fMRI data indicated that both intervention groups experienced less negative emotional arousal and anxiety, with physical tension reduced in the PM group. The PM group exhibited reduced stress response in the frontal lobes when exposed to intensive care unit alarms, suggesting diminished attentional response to the high-stress auditory environment, compared to control. However, lack of statistical significance and baseline variability entail cautious interpretation. Observations of sleep quality were mixed, and no statistically significant differences in stress surveys were observed. <strong>Conclusions:</strong> Both music interventions trended toward positive changes in neurophysiological responses, suggesting potential benefits in reducing surgeon stress. However, due to the small sample, mixed or nonsignificant results, and the exploratory nature of this study, findings should be considered preliminary. Further research with larger, diverse cohorts is required to confirm trends, refine both the intervention approach and recruitment strategies, and determine whether objective compositional elements or personally selected music drive the mechanisms of potential positive effects. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT05980429; https://clinicaltrials.gov/study/NCT05980429
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Development of iGET Living, a Digital Graded Exposure Intervention for Youth With Chronic Pain: Multiphase User-Centered Design and Pilot Study

Background: Pediatric chronic pain affects up to one-third of youth and is associated with significant disruptions in social, emotional, and behavioral functioning. Although behavioral treatments are effective, access remains limited due to geographic, financial, and systemic barriers. Digital behavioral health interventions offer a promising solution, but many lack user-centered design, iterative refinement, and implementation-informed development strategies that support usability and scalability. Objective: This study aimed to develop and iteratively refine iGET Living, a digital graded exposure intervention for youth with chronic pain, using a combined user-centered and implementation-informed framework, and to evaluate its preliminary acceptability, feasibility, and user-perceived success. Methods: Guided by the Consolidated Framework for Implementation Research (CFIR) and the mHealth (mobile health) Agile Development and Lifecycle model, intervention development proceeded through 3 phases. Phase 0 translated an evidence-based in-person graded exposure treatment (GET Living) into an initial digital prototype. Phase 1 involved iterative user-centered refinement across 3 cycles of qualitative development sessions with youth with chronic pain (n=15), incorporating think-aloud usability testing, Likert-rated feedback, and rapid qualitative analysis mapped to CFIR constructs to guide real-time modifications to content, design, and functionality. Phase 2 piloted the refined intervention with a new sample of youth (n=38, n=30 completers) recruited from a tertiary pediatric pain clinic to evaluate feasibility, acceptability, treatment credibility and expectancy, and user-perceived functional improvements. Quantitative outcomes were summarized descriptively, and qualitative exit interview data were analyzed using rapid qualitative analysis. Results: Across development cycles, youth feedback informed substantive refinements to the intervention, including reducing text density, incorporating animated educational videos, enhancing interactive features, and improving navigation and layout. These changes resulted in progressive improvements in clarity, satisfaction, and acceptability across prototypes. In the Phase 2 pilot study, participants reported moderate-to-high treatment credibility (mean of 19.71 out of 30) and expectancy (mean of 17.96 out of 30), as well as high satisfaction (mean of 46.12 out of 60). Acceptability ratings across domains of the Theoretical Framework of Acceptability were favorable. Qualitative exit interviews highlighted the interventions’ perceived role in helping youth re-engage in valued activities. Conclusions: Using a combined CFIR and agile development approach, iGET Living emerged as a feasible, acceptable, engaging digital graded exposure intervention for youth with chronic pain. These findings highlight the value of integrating implementation frameworks and participatory design early in digital intervention development and support further evaluation in a preliminary efficacy trial. Trial Registration: ClinicalTrials.gov NCT05079984; https://clinicaltrials.gov/study/NCT05079984 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2022-065997
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Interoceptive dysfunction and its neural correlates in schizophrenia: protocol for a cross-sectional multimodal MRI study

BackgroundInteroception—the perception and integration of internal bodily signals—is fundamental to emotion regulation, bodily self-awareness, and predictive coding. Emerging evidence suggests that interoceptive disturbances may contribute to core psychopathological features of schizophrenia. Our research group recently conducted a systematic review and meta-analysis demonstrating significant impairments in interoceptive accuracy and sensitivity among individuals with schizophrenia. However, the neural mechanisms underlying these deficits remain unclear.MethodsThis cross-sectional protocol will recruit 30 individuals with schizophrenia and 30 age- and sex-matched healthy controls. Participants will complete (1) behavioral interoceptive assessment using the heartbeat counting task; (2) subjective interoceptive questionnaires, including the Multidimensional Assessment of Interoceptive Awareness (MAIA) and the Body Perception Questionnaire (BPQ); (3) clinical symptom ratings (PANSS, HAM-A, HAM-D); and (4) cognitive testing (TMT, animal fluency, DSST). All participants will undergo multimodal MRI scanning, including structural T1-weighted imaging, resting-state fMRI, and diffusion tensor imaging. Neuroimaging data will be preprocessed and analyzed using DPABISurf, SPM12, and GRETNA. Expected Results: We anticipate that individuals with schizophrenia will show reduced interoceptive accuracy, altered subjective interoceptive awareness, and abnormal intrinsic neural activity and connectivity within interoception-related circuits, including the anterior insula, anterior cingulate cortex, amygdala, and thalamus. Structural abnormalities within thalamo-cortical pathways are also expected. Interoceptive deficits are hypothesized to correlate with symptom severity and cognitive performance.ConclusionsThis study will provide an integrated characterization of interoceptive dysfunction and its neural correlates in schizophrenia. Findings may advance understanding of bodily self-disturbance and emotional dysregulation and support the development of future interoception-focused therapeutic approaches.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2500110551.