Using e-technologies in clinical trials

Rosa, Carmen La; Campbell, Aimee N.C.; Miele, Gloria M.; Brunner, Meg; Winstanley, Erin L.

doi:10.1016/j.cct.2015.07.007

Cited by 135 publications

(121 citation statements)

References 130 publications

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“…Furthermore, we know little about the people who download depression treatment apps in terms of symptom severity, disability, and use of more traditional mental health services. Although a few proof-of-concept studies have found that adherence to depression app guidelines tends to be poor over time [17-21], there is little information about the relative use patterns between different types of apps. We conducted a large-scale RCT (NCT00540865) of 3 different depression apps to answer the following questions: (1) Who downloads mobile apps for depression?…”

Section: Introductionmentioning

confidence: 99%

The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial

Areán¹,

Hallgren²,

Jordan³

et al. 2016

J Med Internet Res

318

307

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BackgroundMobile apps for mental health have the potential to overcome access barriers to mental health care, but there is little information on whether patients use the interventions as intended and the impact they have on mental health outcomes.ObjectiveThe objective of our study was to document and compare use patterns and clinical outcomes across the United States between 3 different self-guided mobile apps for depression.MethodsParticipants were recruited through Web-based advertisements and social media and were randomly assigned to 1 of 3 mood apps. Treatment and assessment were conducted remotely on each participant’s smartphone or tablet with minimal contact with study staff. We enrolled 626 English-speaking adults (≥18 years old) with mild to moderate depression as determined by a 9-item Patient Health Questionnaire (PHQ-9) score ≥5, or if their score on item 10 was ≥2. The apps were (1) Project: EVO, a cognitive training app theorized to mitigate depressive symptoms by improving cognitive control, (2) iPST, an app based on an evidence-based psychotherapy for depression, and (3) Health Tips, a treatment control. Outcomes were scores on the PHQ-9 and the Sheehan Disability Scale. Adherence to treatment was measured as number of times participants opened and used the apps as instructed.ResultsWe randomly assigned 211 participants to iPST, 209 to Project: EVO, and 206 to Health Tips. Among the participants, 77.0% (482/626) had a PHQ-9 score >10 (moderately depressed). Among the participants using the 2 active apps, 57.9% (243/420) did not download their assigned intervention app but did not differ demographically from those who did. Differential treatment effects were present in participants with baseline PHQ-9 score >10, with the cognitive training and problem-solving apps resulting in greater effects on mood than the information control app (χ22=6.46, P=.04).ConclusionsMobile apps for depression appear to have their greatest impact on people with more moderate levels of depression. In particular, an app that is designed to engage cognitive correlates of depression had the strongest effect on depressed mood in this sample. This study suggests that mobile apps reach many people and are useful for more moderate levels of depression.ClinicalTrialClinicaltrials.gov NCT00540865; https://www.clinicaltrials.gov/ct2/show/NCT00540865 (Archived by WebCite at http://www.webcitation.org/6mj8IPqQr)

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Section: Introductionmentioning

confidence: 99%

The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial

Areán¹,

Hallgren²,

Jordan³

et al. 2016

J Med Internet Res

318

307

View full text Add to dashboard Cite

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“…The VACC-Tool facilitates the consistent documentation of adverse events over time. Dynamic data entry systems using mobile devices are likely to become the cornerstone of clinical research in the near future [49,50].…”

Section: Discussionmentioning

confidence: 99%

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

et al. 2016

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“…It based on technology as an add-on, substitute, and replacement for standard care. Technology-enhanced treatment interventions are mainly Webbased versions of evidence-based, in-person treatment components such as CBT and MET [63].…”

Section: E-treatmentsmentioning

confidence: 99%

Review on Treatment of Substance Use Disorders

Njoroge¹

2017

J Addict Res Ther

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Services for mental and substance use disorders have typically been neglected, and in many countries segregated from mainstream health care with resources allocated not commensurate with the burden. The attention given to mental and substance use disorders cannot be compared to other diseases such as HIV/AIDS, Malaria, Cancer, and Diabetes among others. Mental and substance use disorders account to about 7.4% of disease burden worldwide. These disorders are responsible for more of the global burden than HIV/AIDS and tuberculosis, diabetes, or transport injuries.The increasing number of cases of SUDs globally presents a public health challenge that requires effective evidence based interventions. One of the major challenges is inadequate treatment for SUDs which mostly plague developing countries. It may be difficult to measure the efficacy of treatment as a result of unique patient characteristics that contribute to person's treatment experience. Care factors such as duration of treatment and length of stay have been studied as having influence on the outcome of treatment. Others include patient and environmental factors.Globally, poor treatment outcomes mostly reported include dropout rates as high as 90%; relapse rates as high as 91% and high after treatment mortality rates. Research findings have identified many evidence-based treatment strategies for managing substance use disorders, nevertheless there is a gap that continues to exist, that of a lack of success of effective interventions to be spread and implemented so as to improve the lives of those affected. Other studies have also reported these differences in the outcomes and effectiveness of treatment of substance use disorders.There is need for enhanced interventional research that aims at providing an overview of conceptual issues relating to factors that influence treatment outcomes and identifying gaps and directions for improving treatment and treatment outcomes. The fundamental objective of enhanced research in substance use treatment is to reduce the increasing prevalence rates of substance use disorders.

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Using e-technologies in clinical trials

Cited by 135 publications

References 130 publications

The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial

The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study

Review on Treatment of Substance Use Disorders

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