JMIR Publications

ABSTRACT

Background:

Mobile health (mHealth) technologies are being developed at a faster pace than the science to evaluate their validity and efficacy. Under the International Committee of Journal Medical Editors guidelines, clinical trials that prospectively assign people to interventions should be registered with a database prior to the initiation of the study.

Objective:

We sought to better understand the smartphone mHealth trials for high burden neuropsychiatric conditions registered on ClinicalTrials.gov through November 2018 including the number and types of studies being conducted, temporal trends in registration of such studies, the frequency and timing of any outcome changes, and reporting of results.

Methods:

We conducted a systematic search of clinicaltrials.gov for the top ten most disabling neuropsychiatric conditions and pre-specified terms related to mHealth. There were no date, location, or status restrictions.

Results:

Our search identified 135 studies. 39 (28.9%) evaluated interventions for major depressive disorder, 19 (14.1%) for alcohol use disorders, 17 (12.6%) for stroke, 15 (11.1%) for schizophrenia, 11 (8.1%) for anxiety disorders, 11 (8.1%) for other mental and substance use disorders, 10 (7.4%) for opioid use disorders, 5 (3.7%) for Alzheimer Disease or other dementias, 4 (3.0%) for epilepsy and 4 (3.0%) for migraine. Studies were first registered in 2008; more than half were registered in 2016 to 2018. 25 trials (18.5%) had results reported in some publicly accessible location.

Conclusions:

Despite the increasing use of health-based technologies, this snapshot of ClinicalTrials.gov suggests that few such applications for high burden neuropsychiatric conditions are being clinically evaluated in trials.