Characteristics of Neuropsychiatric Mobile Health Trials: Cross-Sectional Analysis of Studies Registered on ClinicalTrials.gov.

BACKGROUND: The development of mobile health (mHealth) technologies is progressing at a faster pace than that of the science to evaluate their validity and efficacy. Under the International Committee of Journal Medical Editors (ICMJE) guidelines, clinical trials that prospectively assign people to interventions should be registered with a database before the initiation of the study. OBJECTIVE: The aim of this study was to better understand the smartphone mHealth trials for high-burden neuropsychiatric conditions registered on ClinicalTrials.gov through November 2018, including the number, types, and characteristics of the studies being conducted; the frequency and timing of any outcome changes; and the reporting of results. METHODS: We conducted a systematic search of ClinicalTrials.gov for the top 10 most disabling neuropsychiatric conditions and prespecified terms related to mHealth. According to the 2016 World Health Organization Global Burden of Disease Study, the top 10 most disabling neuropsychiatric conditions are (1) stroke, (2) migraine, (3) major depressive disorder, (4) Alzheimer disease and other dementias, (5) anxiety disorders, (6) alcohol use disorders, (7) opioid use disorders, (8) epilepsy, (9) schizophrenia, and (10) other mental and substance use disorders. There were no date, location, or status restrictions. RESULTS: Our search identified 135 studies. A total of 28.9% (39/135) of studies evaluated interventions for major depressive disorder, 14.1% (19/135) of studies evaluated interventions for alcohol use disorders, 12.6% (17/135) of studies evaluated interventions for stroke, 11.1% (15/135) of studies evaluated interventions for schizophrenia, 8.1% (11/135) of studies evaluated interventions for anxiety disorders, 8.1% (11/135) of studies evaluated interventions for other mental and substance use disorders, 7.4% (10/135) of studies evaluated interventions for opioid use disorders, 3.7% (5/135) of studies evaluated interventions for Alzheimer disease or other dementias, 3.0% (4/135) of studies evaluated interventions for epilepsy, and 3.0% (4/135) of studies evaluated interventions for migraine. The studies were first registered in 2008; more than half of the studies were registered from 2016 to 2018. A total of 18.5% (25/135) of trials had results reported in some publicly accessible location. Across all the studies, the mean estimated enrollment (reported by the study) was 1078, although the median was only 100. In addition, across all the studies, the actual reported enrollment was lower, with a mean of 249 and a median of 80. Only about a quarter of the studies (35/135, 25.9%) were funded by the National Institutes of Health. CONCLUSIONS: Despite the increasing use of health-based technologies, this analysis of ClinicalTrials.gov suggests that only a few apps for high-burden neuropsychiatric conditions are being clinically evaluated in trials.

Electronic behavioral interventions for headache: a systematic review.

BACKGROUND: There is increasing interest in using electronic behavioral interventions as well as mobile technologies such as smartphones for improving the care of chronic disabling diseases such as migraines. However, less is known about the current clinical evidence for the feasibility and effectiveness of such behavioral interventions. OBJECTIVE: To review the published literature of behavioral interventions for primary headache disorders delivered by electronic means suitable for use outside of the clinician's office. METHODS: An electronic database search of PubMed, PsycINFO, and Embase was conducted through December 11, 2015. All eligible studies were systematically reviewed to examine the modality in which treatment was delivered (computer, smartphone, watch and other), types of behavioral intervention delivered (cognitive behavioral therapy [CBT], biofeedback, relaxation, other), the headache type being treated, duration of treatment, adherence, and outcomes obtained by the trials to examine the overall feasibility of electronic behavioral interventions for headache. RESULTS: Our search produced 291 results from which 23 eligible articles were identified. Fourteen studies used the internet via the computer, 2 used Personal Digital Assistants, 2 used CD ROM and 5 used other types of devices. None used smartphones or wearable devices. Four were pilot studies (N ≤ 10) which assessed feasibility. For the behavioral intervention, CBT was used in 11 (48 %) of the studies, relaxation was used in 8 (35 %) of the studies, and biofeedback was used in 5 (22 %) of the studies. The majority of studies (14/23, 61 %) used more than one type of behavioral modality. The duration of therapy ranged from 4-8 weeks for CBT with a mean of 5.9 weeks. The duration of other behavioral interventions ranged from 4 days to 60 months. Outcomes measured varied widely across the individual studies. CONCLUSIONS: Despite the move toward individualized medicine and mHealth, the current literature shows that most studies using electronic behavioral intervention for the treatment of headache did not use mobile devices. The studies examining mobile devices showed that the behavioral interventions that employed them were acceptable to patients. Data are limited on the dose required, long term efficacy, and issues related to the security and privacy of this health data. This study was registered at the PROSPERO International Prospective Register of Systematic Reviews (CRD42015032284) (Prospero, 2015).

Migraine and its psychiatric comorbidities.

Migraine is a highly prevalent and disabling neurological disorder associated with a wide range of psychiatric comorbidities. In this manuscript, we provide an overview of the link between migraine and several comorbid psychiatric disorders, including depression, anxiety and post-traumatic stress disorder. We present data on psychiatric risk factors for migraine chronification. We discuss the evidence, theories and methods, such as brain functional imaging, to explain the pathophysiological links between migraine and psychiatric disorders. Finally, we provide an overview of the treatment considerations for treating migraine with psychiatric comorbidities. In conclusion, a review of the literature demonstrates the wide variety of psychiatric comorbidities with migraine. However, more research is needed to elucidate the neurocircuitry underlying the association between migraine and the comorbid psychiatric conditions and to determine the most effective treatment for migraine with psychiatric comorbidity.