Dataset Information

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

ABSTRACT:

Importance

Advances in mobile technology have resulted in federal and industry-level initiatives to facilitate large-scale clinical research using smart devices. Although the benefits of technology to expand data collection are obvious, assumptions about the reach of mobile research methods (access), participant willingness to engage in mobile research protocols (engagement), and the cost of this research (cost) remain untested.

Objective

To assess the feasibility of a fully mobile randomised controlled trial using assessments and treatments delivered entirely through mobile devices to depressed individuals.

Design

Using a web-based research portal, adult participants with depression who also owned a smart device were screened, consented and randomised to 1 of 3 mental health apps for treatment. Assessments of self-reported mood and cognitive function were conducted at baseline, 4, 8 and 12?weeks. Physical and social activity was monitored daily using passively collected phone use data. All treatment and assessment tools were housed on each participant's smart phone or tablet.

Interventions

A cognitive training application, an application based on problem-solving therapy, and a mobile-sensing application promoting daily activities.

Results

Access: We screened 2923 people and enrolled 1098 participants in 5?months. The sample characteristics were comparable to the 2013 US census data. Recruitment via Craigslist.org yielded the largest sample. Engagement: Study engagement was high during the first 2?weeks of treatment, falling to 44% adherence by the 4th week. Cost: The total amount spent on for this project, including staff costs and ? testing, was $314?264 over 2?years.

Conclusions and relevance

These findings suggest that mobile randomised control trials can recruit large numbers of participants in a short period of time and with minimal cost, but study engagement remains challenging.

Trial registration number

NCT00540865.

SUBMITTER: Anguera JA

PROVIDER: S-EPMC4789688 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

Anguera Joaquin A JA Jordan Joshua T JT Castaneda Diego D Gazzaley Adam A Areán Patricia A PA

BMJ innovations 20160101 1

<h4>Importance</h4>Advances in mobile technology have resulted in federal and industry-level initiatives to facilitate large-scale clinical research using smart devices. Although the benefits of technology to expand data collection are obvious, assumptions about the reach of mobile research methods (<i>access</i>), participant willingness to engage in mobile research protocols (<i>engagement</i>), and the cost of this research (<i>cost</i>) remain untested.<h4>Objective</h4>To assess the feasibi ...[more]

PMID: 27019745

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Project description:BACKGROUND:Mobile 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. OBJECTIVE:The 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. METHODS:Participants 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. RESULTS:We 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 (?22=6.46, P=.04). CONCLUSIONS:Mobile 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. CLINICALTRIAL:Clinicaltrials.gov NCT00540865; https://www.clinicaltrials.gov/ct2/show/NCT00540865 (Archived by WebCite at http://www.webcitation.org/6mj8IPqQr).

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Dataset Information

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

Importance

Objective

Design

Interventions

Results

Conclusions and relevance

Trial registration number

Publications

Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

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