Trial reportAnnals of behavioral medicine : a publication of the Society of Behavioral Medicine2025
Mitigating fraud in a fully decentralized clinical trial of a digital health intervention.
Trial report in Annals of behavioral medicine : a publication of the Society of Behavioral Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04925570 (Woebot for Substance Use Disorders Phase 2 RCT), which is not on this map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Woebot for Substance Use Disorders Phase 2 RCT: Digitally Delivered Intervention for Reducing Problematic Substance Use
Who cites it
3 citing papers in PubMed.
- A US-Based National Virtual Cohort of People Living With HIV at Risk for Viral Nonsuppression: Protocol for the EPI-LoVE Prospective Cohort Study.JMIR research protocols · 2026Article
- Advancing translational science through trial integrity: REDCap-based approaches to mitigating fraud and bias.Journal of clinical and translational science · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundDecentralized clinical trials (DCT), digital survey methodologies, and health monitoring technologies create the potential to reduce study participant burden as well as enhance sample diversity and enrollment pace. However, fraudulent participant activity poses a significant threat to study validity and data integrity. PURPOSE: This study quantifies fraudulent attempts at participation in a DCT of a mobile mental health intervention for problematic substance use and discusses methods to prevent and detect fraudulent activity.
methodsAdults residing in the US reporting problematic substance use were recruited for a fully remote DCT via 2 primary channels: social media advertisements and survey panels. The DCT offered incentives totaling up to $100 for completing assessments over the 12-week study. To prevent and detect fraudulent activity, the research team utilized VPN and proxy detection, checked for duplicate identifiers (e.g., emails, phone numbers, IP Addresses), and compared age and date of birth (DOB) responses across timepoints. Descriptive statistics and group comparisons across the 2 sources of recruitment methodology were utilized to quantify and characterize fraudulent activity.
resultsOf the 2,781 eligible screeners completed, 1,725 (62%) were determined to be fraudulent prior to randomization, detected most commonly by duplicate identifiers (65%) and/or VPN and proxy detection (47%). Of the 258 randomized participants, 51 (20%) were later determined to be fraudulent based upon age and/or DOB mismatch. Notable patterns in fraudulent activity (e.g., 42% of fraudulent screening respondents reported the exact age of 30 years; stylistic formatting of email address accounts) were identified. The fraudulent recruitment rate was higher for social media advertising (85%) than survey panels (26%).
conclusionsBoth social media and survey panel recruitment resulted in high levels of fraudulent activity in a DCT of a mobile mental health intervention. Researchers conducting DCTs and/or online surveys are urged to take several precautions and preventative measures to insulate against fraudulent activity including embedding identity verification procedures in consent processes. Researchers should consider making personal contact with a participant to verify identity as well as remain vigilant for fraudulent activity and its real-time dynamic potential.
trial registrationNCT04925570.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.