Tag: Clinical trial

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Examining the Feasibility, Acceptability, and Preliminary Efficacy of a Health App for Postacute Pandemic Years in Managing Physical and Psychological Distress Symptoms: Pilot Quasi-Experimental Study

<strong>Background:</strong> Physical and psychological distress symptoms can adversely affect daily functioning and quality of life, highlighting the need for accessible self-management support. Although mobile health (mHealth) interventions show promise in supporting physical symptom management, evidence regarding their feasibility and potential effects on psychological distress remains limited. <strong>Objective:</strong> This pilot study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of the health app for postacute pandemic years (HAPPY) for managing physical and psychological distress symptoms. <strong>Methods:</strong> A 2-arm, single-blind, quasi-experimental trial was conducted from July 2023 to January 2024. Thirty-eight participants experiencing distress symptoms related to COVID-19 were assigned to the experimental group or a waitlist control group. The experimental group received a 24-week mHealth intervention through the HAPPY app, which included an 8-week supervised phase with weekly face-to-face sessions and a 16-week self-management phase. The control group received no active treatment. Feasibility was assessed through recruitment, adherence, and adverse event monitoring, whereas preliminary efficacy was evaluated at 8 weeks (T1) and 24 weeks (T2) and compared with baseline (T0) using quantitative measures of distress, fatigue, sleep quality, pain, emotional regulation, and posttraumatic stress disorder (PTSD). <strong>Results:</strong> The study demonstrated the feasibility of the HAPPY app, with a recruitment rate of 88.37% (38/43), a dropout rate of 10.5% (4/38), and an adherence rate of 93.33% (14/15) for the supervised sessions. No adverse events were reported. Significant within-group improvements were observed for distress (Kessler Psychological Distress Scale [K10]; <i>P</i>&lt;.001), fatigue (Brief Fatigue Inventory–Chinese [BFI-C]; <i>P</i>&lt;.001), sleep quality (Chinese Pittsburgh Sleep Quality Index [CPSQI]; <i>P</i>=.009), and PTSD symptoms (Chinese Impact of Event Scale–Revised [CIES-R]; <i>P</i>=.02). However, between-group differences were limited. <strong>Conclusions:</strong> The study demonstrated the HAPPY app’s feasibility, acceptability, and potential efficacy for managing physical and psychological distress symptoms. High recruitment, retention, and adherence rates, along with measurable improvements in distress, fatigue, sleep quality, and pain, suggest the app’s promise as a scalable intervention. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT05459896; https://clinicaltrials.gov/study/NCT05459896
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Encoded Therapeutics Reports Promising Results for Dravet Gene Therapy

Encoded Therapeutics’ reports good interim safety and early efficacy findings from its ongoing Phase I/II trials of its gene therapy for treatment of the rare neurological condition Dravet syndrome.

As reported at the European Society of Gene and Cell Therapy conference in Hamburg, results from 21 patients treated in three open label Phase I/II trials showed no serious adverse events or dose-limiting toxicities of the adeno-associated virus (AAV) vector therapy ETX101.

In addition, positive efficacy results were seen including a significant reduction in seizures and improvements in neurodevelopment in the children treated with ETX101 including better communication, cognition, and skills acquisition.

Dravet syndrome is a rare, severe, lifelong genetic epilepsy, impacting around one in 20,000 births in the U.S., that usually begins in the first year of life. It causes prolonged seizures and is difficult to control with medicines. As children get older, development typically slows and learning, language, movement, and behavior are all adversely affected.

Most cases of Dravet syndrome are caused by a disease-causing variant in the SCN1A gene, which encodes a sodium-channel protein involved in nerve-cell signaling.

There are approved treatments available to control Dravet seizures, but to date no genetic therapies are approved to address the root cause of this condition. ETX101 delivers instructions for an engineered protein that increases SCN1A activity selectively in inhibitory neurons. Rather than replacing or editing the faulty gene, it aims to boost production of NaV1.1, the sodium-channel protein deficient in most Dravet cases.

Speaking at the conference, Salvador Rico, MD, PhD, chief medical officer at Encoded Therapeutics, described the interim results from the three studies, which are open-label, without a control. The team treated 21 children aged six months to seven years with a single brain-ventricle injection of ETX101, while continuing standard antiseizure medicines. Four different doses of the therapy were tested.

Seizure reduction was good particularly at the higher two doses. Three children at dose level 3 had a median reduction of approximately 76% through one year. At the highest dose, four children receiving prednisolone without sirolimus had an approximately 84% reduction between enrollment and week 16.

“Seeing this level of effect in a population this refractory, especially in that period of time … is really remarkable and without precedent,” said Rico.

The researchers also reported communication and adaptive-skill gains after treatment. Children treated at or before age two appeared to acquire cognitive skills at a pace approaching typical development.

“Rather than entering the expected pattern of stagnation, these patients are showing an acquisition of skills that is most consistent with typical development,” explained Rico. “This is suggesting that we may be rescuing learning abilities.”

No serious adverse events were reported to date, but six children developed elevated liver enzymes.

Based on these early promising results, Encode is now testing ETX101 in a larger Phase II clinical trial. Another gene-targeted approach being developed by Stoke Therapeutics/Biogen for treatment of Dravet syndrome, zorevunersen, uses repeatedly administered antisense oligonucleotide (ASO) molecules to increase NaV1.1 production. It has also produced encouraging seizure and developmental findings and is currently in Phase III testing.

The post Encoded Therapeutics Reports Promising Results for Dravet Gene Therapy appeared first on Inside Precision Medicine.

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Dance- and movement-based interventions for autism spectrum disorder: a systematic review and exploratory meta-analysis

ObjectivesAutism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition characterized by difficulties in social communication, restricted and repetitive behaviors, and impaired adaptive functioning. Although behavioral and developmental interventions remain central to ASD management, the effects of dance- and movement-based interventions (DMIs) across different functional domains have not been fully clarified. This study aimed to systematically evaluate the effects of DMIs on overall autism symptom severity, social communication/social responsiveness, and motor function in individuals with ASD.MethodsThis systematic review and meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Eligible DMIs included formal dance/movement therapy or dance movement psychotherapy and other structured dance- or purposeful movement programs in which movement constituted a central therapeutic or rehabilitative component. PubMed, Web of Science, Embase, the Cochrane Library, and PsycINFO were searched from inception to August 2026. Randomized and non-randomized controlled studies were not combined in the same primary meta-analysis. Randomized studies reporting sufficiently comparable outcomes were synthesized using standardized mean differences (SMDs) with 95% confidence intervals (CIs) under random-effects models. Risk of bias was assessed using RoB 2 and ROBINS-I, and certainty of evidence was evaluated using GRADE.ResultsTwelve controlled studies involving individuals with ASD were included and showed substantial variation in intervention format, comparator conditions, outcome measures, and risk of bias. Exploratory RCT-only meta-analyses included three studies for social communication/social responsiveness (n = 76; SMD = −0.68, 95% CI: −1.58 to 0.23; p = 0.15; I² = 72%) and three studies for motor function (n = 55; SMD = 2.04, 95% CI: −0.52 to 4.61; p = 0.12; I² = 92%); certainty of evidence was very low for both domains. Overall autism symptom severity was represented by one randomized trial (n = 30; SMD = −3.09, 95% CI: −4.19 to −1.99), resulting in low-certainty evidence and precluding pooling. Narrative synthesis identified potentially favorable signals in joint engagement, cooperative behavior, interpersonal synchrony, emotion inference, and gesture imitation, but these findings arose from small and heterogeneous studies.ConclusionThe current evidence base for DMIs is small, heterogeneous, and of low to very low certainty. Structured narrative synthesis suggests possible domain-specific benefits, whereas exploratory pooled estimates for social communication/social responsiveness and motor function remain inconclusive. DMIs may have potential as complementary interventions for ASD, but larger, methodologically rigorous randomized trials with standardized interventions and outcome measures are required.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420261495230, identifier CRD420261495230.
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Effects of Telerehabilitation on Quality of Life, Physical Capacity, and Symptom Burden Within the Post–COVID-19 Condition: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Background: Post–COVID-19 condition (PCC) is characterized by persistent symptoms and functional limitations that impair quality of life, and rehabilitation is an important component of its management. Because access to conventional face-to-face rehabilitation may be limited, telerehabilitation has emerged as an accessible alternative. However, the effectiveness of telerehabilitation across clinical outcomes remains uncertain, and the influence of different delivery modes is not well understood. Objective: This study aimed to evaluate the effects of telerehabilitation on health-related quality of life (HRQoL), physical capacity, and symptom burden in adults with PCC, and to determine whether delivery mode (synchronous, asynchronous, or hybrid) modified these effects. Methods: Seven databases (PubMed, Cochrane Library, Web of Science, Scopus, Embase, EBSCO, and PEDro) were searched for randomized controlled trials published from January 2020 through December 2025. Eligible trials enrolled adults with PCC and compared telerehabilitation with usual care or another control condition. The primary outcome was HRQoL; secondary outcomes included functional capacity assessed by the 6-minute walk test and sit-to-stand test, dyspnea, fatigue, and symptoms of anxiety and depression. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Mean differences or standardized mean differences (SMDs) with 95% CIs were pooled using random-effects models with the Hartung-Knapp-Sidik-Jonkman adjustment. Heterogeneity was quantified using I² and τ², with 95% prediction intervals reported where estimable. Certainty of evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Results: A total of 22 randomized controlled trials involving 2294 participants were included. Telerehabilitation was associated with significant improvements in HRQoL (SMD 1.26, 95% CI 0.07-2.45; <i>P</i>=.04), dyspnea (SMD 1.95, 95% CI 0.60-3.31; <i>P</i>=.005), and functional aerobic capacity (6-minute walk test : mean difference 77.79 meters, 95% CI 30.44-125.14; <i>P</i>=.001). Fatigue was also significantly reduced (SMD 0.89, 95% CI 0.16-1.62; <i>P</i>=.02), but no significant effects were observed for lower-limb strength (sit-to-stand test: SMD 0.55, 95% CI –0.15 to 1.25; <i>P</i>=.12) or symptoms of anxiety and depression (SMD 0.12, 95% CI –0.13 to 0.38; <i>P</i>=.36). No significant differences between delivery modes were observed for HRQoL (<i>P</i>=.93), functional aerobic capacity (<i>P</i>=.29), or dyspnea (<i>P</i>=.16). A significant subgroup difference was observed for lower-limb strength (<i>P</i>=.02). Conclusions: Telerehabilitation may improve quality of life, aerobic capacity, and symptom burden in PCC and offer an accessible option for post-COVID rehabilitation, although the certainty of evidence was generally limited. Asynchronous delivery appears feasible for general reconditioning, whereas its benefit for lower-limb strength and the value of synchronous supervision remain uncertain. Clinical Trial: PROSPERO CRD42023490863; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023490863
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Human-in-the-Loop Suicide Risk Detection and Clinical Escalation in a Generative AI Mental Health Chatbot: Prospective Implementation Study

<strong>Background:</strong> Mental illness is a leading cause of disability worldwide, affecting more than 1 billion people, and suicide accounts for 720,000-800,000 deaths annually. Although AI-native mental health chatbots have the potential to help address the substantial gap between treatment needs and workforce capacity, their rapid proliferation has outpaced the development of scalable procedures for identifying and responding to suicidal ideation. Although recommendations call for human oversight to support safety monitoring and intervention in AI-based care, research on human clinical oversight and crisis-response procedures remains limited. <strong>Objective:</strong> This study aims to implement a human-in-the-loop (HITL) protocol for suicide risk screening, detection, and clinical escalation in a generative AI (GenAI) mental health chatbot. <strong>Methods:</strong> In this implementation study of a HITL suicide risk detection and escalation protocol, adults were recruited online to participate in a single-arm trial of an AI-native mental health chatbot. Participants completed baseline screening using the 9-item Patient Health Questionnaire (PHQ-9). In phase 1, participants who endorsed suicidal ideation were referred to a human clinician for further assessment, safety planning, and provision of referral resources, as appropriate. In phase 2, escalation was triggered by either PHQ-9 responses or the detection of spontaneous, implicit, or explicit disclosures of suicidality during chatbot interactions. In both phases, the Ask Suicide-Screening Questions guided clinician-led assessment and risk stratification. Outcomes included the prevalence of suicidal ideation, the rate of successful clinician outreach, the time from risk detection to initiation of clinician outreach, and the results of risk stratification. <strong>Results:</strong> In phase 1, 624 participants completed suicide risk screening, of whom 81 (13%) endorsed PHQ-9 item 9 (score ≥1). Clinician outreach was initiated, on average, 11.2 minutes (SD 13.2 minutes; range 1-54 minutes) after the alert, and 25 of the 81 (31%) participants were successfully reached. In phase 2, 650 participants completed screening, of whom 133 (20.5%) screened positive at baseline. During the 30-day postbaseline observation period, 284 risk-alert events were generated among 172 (26.5%) participants, including 50 conversational suicidal ideation alerts. Clinicians successfully reached 73 of the 172 (42.4%) participants. The mean time from risk detection to initiation of clinician outreach was 11.5 minutes (SD 11.7 minutes; range 1-58 minutes). <strong>Conclusions:</strong> Proactive, universal suicide risk screening and conversational detection using a HITL protocol can be operationally implemented in a GenAI mental health chatbot. A subset of participants who were successfully reached by a human clinician described the approach as acceptable and helpful. Given that clinical contact and assessment were not completed for a substantial proportion of alerted participants, further research is needed to optimize assessment and follow-up strategies for individuals who cannot be reached and to characterize the impact of these procedures on clinical outcomes. Nevertheless, the safety procedures described herein provide a framework for developing and refining HITL safety responses and protocols for purpose-built, AI-native mental health chatbots.
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In-person UCLA-PEERS® program for adolescents with autism spectrum disorder in Italy: study protocol for a pilot and feasibility randomized controlled trial with pragmatic features and exploratory EEG markers of treatment response

BackgroundAdolescents with Autism Spectrum Disorder (ASD) Level 1 frequently experience persistent difficulties in peer relationships and social functioning that become more evident as social demands increase. Group-based social skills trainings represent a key evidence-based intervention for this population, yet its availability in routine clinical services is still limited. The Program for the Education and Enrichment of Relational Skills (PEERS®) is one of the most empirically supported interventions for autistic adolescents. In Italy, telemedicine delivery has shown promising results, but the effectiveness and implementation of the in-person format in real-world services have not yet been evaluated. In addition, predictors of individual response to psychosocial interventions remain largely unknown.MethodsThis study is designed as a two-arm pilot and feasibility randomized controlled trial incorporating pragmatic features, including delivery within a routine tertiary clinical service, comparison with Treatment as Usual (TAU), and allowance for ongoing concomitant clinical, educational, and pharmacological treatments. It will compare the in-person Italian adaptation of UCLA PEERS® with Treatment as Usual (TAU) at IRCCS Fondazione Stella Maris (Pisa, Italy). Thirty-six adolescents aged 11–13 years with ASD (DSM-5-TR) and Full-Scale IQ >85 will be assessed at baseline (T0) and after the 16-week intervention (T1). Randomization will use block allocation with allocation concealment until completion of baseline assessments; outcome assessors and independent ADOS–BOSCC video coders will remain blind to group assignment. The intervention includes sixteen weekly 90-minute group sessions delivered by certified providers, with parallel caregiver sessions and structured teacher contacts to promote generalization. The primary focus of this pilot trial is feasibility, assessed through recruitment, retention, session attendance, and treatment fidelity. Clinical outcomes will be examined exploratorily to provide preliminary estimates of treatment effects. The QSQ-R will serve as the prespecified principal clinical outcome for estimating change in social functioning from baseline to T1. Parent- and adolescent-report versions will be analyzed separately, considering the Social Initiative and Social Reciprocity dimensions as distinct outcomes rather than deriving a composite total score. Key secondary outcomes include social knowledge (TASSK-R), autism-related social responsiveness (SRS-2), social motivation (SSDS), social anxiety (SAS), and observational change in social-communication behaviors (ADOS–BOSCC). Emotional–behavioral functioning (CBCL; YSR) will be explored as additional secondary outcomes. Baseline electroencephalography (EEG) recorded during a gesture–word integration task will be used to derive the N400 congruency effect and to explore whether individual differences in this measure are associated with treatment response. As a pilot and feasibility trial, the study is not powered for definitive efficacy testing and will estimate feasibility, acceptability, fidelity, and preliminary effect sizes to inform future multicenter trials.DiscussionThis study will provide the first evaluation of in-person PEERS® in the Italian clinical context and test the generalizability of previous telemedicine findings in routine care. The integration of clinical and behavioral outcomes may contribute to mechanism-informed, personalized psychosocial interventions for autistic adolescents and guide the design of future confirmatory studies.Trial registration(ClinicalTrials.gov – NCT07207213 – October, 3, 2025).
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Understanding the Influence of Substance Use, Mental Health, and Stigma on Smoking Behavior Among People Living With HIV: Rapid Qualitative Analysis

Background: In Vietnam, an upper-middle-income country, the majority of people living with HIV smoke. Vietnam has established quitline services to support this population, but they remain underused. Text messaging is widely used in Vietnam, and studies in other countries have shown that text messaging interventions can promote smoking cessation. Our goal was to conduct a formative study to inform the development of a text messaging intervention to increase access to quitline services and promote smoking cessation among people living with HIV who smoke in Vietnam. Objective: This study aimed to identify factors influencing smoking behaviors among people living with HIV in Vietnam through qualitative interviews to inform a tailored text messaging intervention. Methods: In October 2022, study staff conducted 30- to 45-minute qualitative interviews with 20 people living with HIV from clinics in Hai Phong and Quang Ninh provinces, Vietnam. Interviews explored factors that influenced smoking, such as substance use, mental health, HIV stigma, social context, and health. A rapid qualitative analysis approach was used to synthesize themes from the data, including identifying key domains based on prior literature, developing a semistructured interview guide, and organizing data within domains to support iterative theme development. These interviews were used to develop prompts to guide people living with HIV who smoke in writing peer messages for a text messaging intervention. Results: Across 6 themes, participants described smoking as part of their everyday lives, shaped by social situations, stress, alcohol use, and their experiences living with HIV. Social smoking and early initiation were important influences on smoking behaviors, whereas financial concerns and protecting family members and others from secondhand smoke promoted cessation. Some participants used smoking to cope, whereas others wished to quit for better health. HIV stigma was a major contributor to smoking, with many participants describing increased smoking after diagnosis. Participants suggested that cessation support should be better tailored to their needs. Conclusions: Smoking behaviors among people living with HIV are shaped by overlapping influences, including societal norms, mental health, HIV-related stigma, and other structural stressors. An understanding of these overlapping factors can inform the development of text-based interventions that offer effective cessation support tailored to this population. Trial Registration: ClinicalTrials.gov NCT05863923; https://clinicaltrials.gov/study/NCT05863923
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Feasibility of Online and On-Site Physical Activity Delivery Among Older Adults: Mixed Methods Pilot Randomized Controlled Trial

<strong>Background:</strong> Physical activity (PA) is central to healthy aging, yet interventions targeting older adults often report substantial attrition and variable adherence. Although digital and internet-based exercise programs broaden accessibility and flexibility, their ability to sustain engagement compared with traditional on-site formats remains unclear. Understanding how delivery mode influences attrition and adherence—and why participants persist or withdraw—is essential for designing inclusive and sustainable PA interventions. <strong>Objective:</strong> This pilot study evaluates the feasibility of delivering a 26-week PA intervention to older adults through 2 modes: online or on-site. Feasibility was assessed primarily by attrition, adherence, and participants’ experiences of factors influencing continued participation or withdrawal. Additionally, the study explores preliminary patterns in PA levels and physical and mental health outcomes to inform the design of a future definitive trial. <strong>Methods:</strong> This 26-week pragmatic pilot trial used an embedded convergent mixed methods design. Community-dwelling adults aged 60 years or older (N=35) from 3 residential areas in Sweden were cluster-randomized, without blinding, by site to an online (prerecorded video-based Otago exercises; n=12) or on-site (group-based, in-person Otago exercises; n=23) delivery mode. Feasibility outcomes included attrition and adherence. Exploratory outcomes included PA level (Godin-Shephard Leisure-Time Exercise Questionnaire), lower-body strength (Chair Stand Test), depressive symptoms (Geriatric Depression Scale), and health-related quality of life (EQ-5D-3L), assessed at baseline, midintervention (14 weeks), and postintervention (26 weeks). Exploratory quantitative analyses included t tests, chi-square tests, analysis of covariance, and mixed-design ANOVAs. We analyzed semistructured interviews with completers (n=17) and dropouts (n=7) using qualitative content analysis. Findings were integrated using the COM-B (Capability, Opportunity, Motivation-Behavior) framework. <strong>Results:</strong> The overall attrition rate was 37% (13/35), with no significant difference between delivery modes (<i>P</i>=.29). Most dropouts occurred within the first 2 weeks. Mean adherence appeared higher in the online delivery mode (mean 17.0, SD 6.7) than in the on-site delivery mode (mean 12.1, SD 10.1) but did not differ significantly (<i>P</i>=.15). Qualitative findings indicated that attrition was primarily driven by physical health issues and a perceived lack of fit, whereas adherence was supported by appeal and reward, routine and commitment, flexibility, feedback and PA overview, and (often) social presence. Mixed methods findings suggest that capability, opportunity, and motivation supported participation across both delivery modes. No intervention-related adverse events were reported. <strong>Conclusions:</strong> Both online and on-site delivery modes for PA interventions appeared feasible for many older adults. Although no statistically significant between-group differences were observed, the study was not powered to evaluate effectiveness. Feasibility may depend more on supporting capability, opportunity, and motivation than on delivery mode. Larger, adequately powered trials are needed to test effectiveness, identify optimal formats for different populations, and evaluate strategies to reduce early attrition. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT05885308; https://clinicaltrials.gov/ct2/show/NCT05885308
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Incorporating Objective Behavioral and Biological Measures in a Large-Scale Decentralized Mobile Health Trial for Depression: Randomized Controlled Trial

Background: Decentralized (ie, fully remote) clinical trials (DCTs) offer a scalable and ecologically valid approach to evaluating digital mental health interventions (DMHIs). Yet, incorporating objective measures of well-being within DCTs poses novel methodological and feasibility challenges that can limit the rigor and precision of data collection in the field. Objective: We recently conducted the Behavior, Biology, and Well-being (BeWell) Study, a large-scale, 3-arm randomized DCT evaluating the Healthy Minds Program app (Humin)—a self-guided DMHI that includes didactic well-being information and meditation components. The current paper’s objective is to describe the methodological approach to collecting and processing a multimodal battery of psychological (questionnaires and structured clinical interview), biological (blood and stool assays), and behavioral (stimulus-elicited affect [SEA] task, video log, and Mnemonic Similarity Task [MST]) measures, longitudinally across baseline, the 4-week intervention period, and 17-week follow-up. Secondarily, we evaluate its feasibility. Methods: The BeWell Study methodology is described. Descriptive statistics characterized recruitment and retention, as well as data completion and data quality. Binary logistic regressions evaluated whether recruitment sources, demographics, and depression severity predicted measure completion and data quality. Results: From June 1, 2022, through July 15, 2024, 52,052 individuals started the screening questionnaire. Of these, 2.22% (n=1156 participants; mean age 38.69, SD 12.14 years; women=75.50%; non-Hispanic White=68.88%) completed the screener, met eligibility criteria (including elevated depressive symptoms [Patient Health Questionnaire-9 [PHQ-9] score≥5]), completed baseline measures, were enrolled, and were randomized. Participants were recruited from Craigslist (694/1154, 60.14%), a US-based advertisement website, and university email messages (107/1154, 9.27%); participants were enrolled from every US state. Across the study, 84% (971/1156) of participants were retained (completed ≥1 measure at 17-week follow-up). Across time points, ≥81.40% (941/1156) of participants completed questionnaires and ≥75.17% (869/1156) completed biological samples. Of those completing questionnaires, ≥84.14% (796/946) completed SEA and video log tasks and ≥91.75% (868/946) completed the MST. Of completed assessments, high-quality or analyzable data rates across all time points were ≥97.89% (926/946) for questionnaires, ≥90.20% (773/857) for SEA, ≥84.60% (725/857) for video logs, ≥94.20% (1056/1121) for the MST, ≥98.84% (849/859) for dried blood spots, and ≥99.43% (865/870) for microbiome samples. Greater depressive symptoms at screening, but not age, predicted completion of baseline measures (odds ratios 0.96‐0.99; <.001). For enrolled participants, recruitment sources and baseline depressive symptoms were not predictive of data completion or quality. Older age and having a college degree predicted significantly higher rates of data completion across all data types (questionnaire, behavioral, and biological) at week 4 or week 17 follow-ups. Conclusions: This methodological approach offers one model of incorporating objective measures of well-being into DCTs testing DMHIs. Implications and limitations of our approach are discussed. Trial Registration: ClinicalTrials.gov NCT05183867; https://clinicaltrials.gov/study/NCT05183867