Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet

Background: This paper presents the protocol for the National Institute of Mental Health (NIMH)–funded University of Washington’s ALACRITY (Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness) Center (UWAC), which uses human-centered design (HCD) methods to improve the implementation of evidence-based psychosocial interventions (EBPIs). We propose that usability—the degree to which interventions and implementation strategies can be used with ease, efficiency, effectiveness, and satisfaction—is a fundamental, yet poorly understood determinant of implementation.Objective: We present a novel Discover, Design/Build, and Test (DDBT) framework to study usability as an implementation determinant. DDBT will be applied across Center projects to develop scalable and efficient implementation strategies (eg, training tools), modify existing EBPIs to enhance usability, and create usable and nonburdensome decision support tools for quality delivery of EBPIs.Methods: Stakeholder participants will be implementation practitioners/intermediaries, mental health clinicians, and patients with mental illness in nonspecialty mental health settings in underresourced communities. Three preplanned projects and 12 pilot studies will employ the DDBT model to (1) identify usability challenges in implementing EBPIs in underresourced settings; (2) iteratively design solutions to overcome these challenges; and (3) compare the solution to the original version of the EPBI or implementation strategy on usability, quality of care, and patient-reported outcomes. The final products from the center will be a streamlined modification and redesign model that will improve the usability of EBPIs and implementation strategies (eg, tools to support EBPI education and decision making); a matrix of modification targets (ie, usability issues) that are both common and unique to EBPIs, strategies, settings, and patient populations; and a compilation of redesign strategies and the relative effectiveness of the redesigned solution compared to the original EBPI or strategy.Results: The UWAC received institutional review board approval for the three separate studies in March 2018 and was funded in May 2018.Conclusions: The outcomes from this center will inform the implementation of EBPIs by identifying cross-cutting features of EBPIs and implementation strategies that influence the use and acceptability of these interventions, actively involving stakeholder clinicians and implementation practitioners in the design of the EBPI modification or implementation strategy solution and identifying the impact of HCD-informed modifications and solutions on intervention effectiveness and quality.Trial Registration: ClinicalTrials.gov NCT03515226 (https://clinicaltrials.gov/ct2/show/NCT03515226), NCT03514394 (https://clinicaltrials.gov/ct2/show/NCT03514394), and NCT03516513 (https://clinicaltrials.gov/ct2/show/NCT03516513).International Registered Report Identifier (IRRID): DERR1-10.2196/14990

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 β 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.

Several barriers complicate access to psychotherapy for depression, including time commitment, location of services, and stigma. Digital treatment has the potential to address these barriers, yet long term use of digital psychotherapy is poor. This paper presents data from a mixed-methods, online survey to document concerns patients with depression face when given the choice of in-person psychotherapy and digital psychotherapy. Participants were 164 adults living in the United States who had previously used or considered psychotherapy for depression. Rural-dwelling and racial/ethnic minority (Native American, African American, and Spanish-speaking) respondents were purposively sampled. Participants were asked their preferences for and opinions about four treatment modalities: self-guided digital, peer-supported digital, expert-guided digital, or in-person psychotherapy. Less than half (44.5%) of participants preferred in-person psychotherapy, 25.6% preferred self-guided digital treatment, 19.7% preferred expert-guided digital treatment, and 8.5% peer-supported digital treatment. Principal themes extracted from qualitative analysis centered on the efficacy of digital treatment, access to digital treatment, concerns about peer-supported care, confidentiality and privacy concerns, preference for in-person treatment, skepticism about self-guided therapy, and the impact of social anxiety on the use of video-chat based care. Future development of digital psychotherapy will need to address concerns regarding efficacy, privacy, data security, and methods to enhance motivation to use these treatments.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Most people with mental health disorders fail to receive timely access to adequate care. Digital technology has the potential to drive a sea change in the psychosocial treatment of mental health problems, especially in minority populations that have known barriers to accessing and utilizing traditional treatment approaches. Objective: The objective of the present study was to compare recruitment, engagement, and treatment outcomes between a sample of depressed Spanish-speaking Hispanic/Latino individuals compared to a cohort of depressed English speakers using 3 different self-guided mobile apps (iPST (based on evidence-based therapeutic principles from problem-solving therapy [PST]); Project: Evolution™ (EVO; a cognitive training app based on cognitive neuroscience principles); and Health Tips (health information app that served as an information control)). Methods: Participants were recruited for this randomized controlled trial using social media platforms, internet-based advertisements, and traditional fliers in select locations in each state across the United States. Assessment and self-guided treatment was conducted on each participant's smartphone or tablet. We enrolled 646 English-speaking and 437 Spanish-speaking adults (≥18 years old) with mild to moderate depression as determined by a 9-item Patient Health Questionnaire (PHQ-9) score ≥5 or an endorsement of impaired functioning. Outcomes were depressive symptom severity (measured using PHQ-9) and functional impairment (assessed with Sheehan Disability Scale). Engagement in the study was assessed based on the number of times participants completed active surveys. Results: We screened 4,502 participants and enrolled 1,083 participants from throughout the US over 6 months. The majority of the participants were recruited via posts on craigslist.org, with significant participant acquisition costs present when recruiting Spanish speakers ($31/ participant) compared to English speakers ($1.46/participant). Long-term engagement surfaced as a key issue with Spanish speaking participants, as these individuals dropped out two weeks earlier than their English counterparts. Furthermore, while no significant difference between Spanish- and English speakers were observed for treatment remission, Spanish-speakers consistently reported higher depression symptoms compared to their English speaking counterparts. Conclusions: Our findings suggest that fully remote mobile-based studies can attract a diverse participant pool including people from lower socioeconomic backgrounds (in this case Hispanic/Latinos). However, keeping participants engaged in this type of ‘low-touch’ research study remains challenging. Further research including user-centered approaches are needed to understand the culturally adequate incentive levels, notification strategies and effective mobile content formatting to enhance the recruitment and retention of minority populations. Clinical Trial: Clinicaltrials.gov Identifier: NCT01808976