Review method and strategy

This project undertakes formative research to design and test ‘TraitMap’, a personalised mobile app designed to detect cravings and intervene with self-monitoring and feedback as cravings develop. Thus countering many of the harms associated with drug use. To achieve these aims, a 3-stage app development project is proposed. First, multi-stakeholder feedback is collated via online surveys. Second, a mobile app ‘TraitMap’ is designed to respond to trait vulnerabilities in people with M/SUDs. Finally, a pilot randomised controlled trial examines the feasibility of TraitMap to reduce drug harms in people with M/SUDs.
To design an app that is responsive to people with M/SUDs, the project will need to overcome significant user-centric and technological design challenges. To this end, the study will conduct several online surveys to collect feedback from multi-stakeholders (e.g., healthcare providers, medical researchers, app developers, end-users). These online surveys will focus on three stages of the app design process: prototyping, evaluation, and pilot study. This iterative process is scheduled to evolve over a 12-month period (July 2016 – July 2017).
  1. The Prototyping stage (July – September 2016) will develop the TraitMap prototype based on aggregated findings from an online survey. The survey will be compiled by Principle Investigator (Munro) using Typeform.com and promoted via online support communities. Aggregated multi-stakeholder feedback will inform the initial TraitMap prototype which will be built using open-source development platform ResearchKit (www.researchkit.org). Studies by world-leading medical research units at Stanford, Johns Hopkins, and Oxford show ResearchKit counters many of the methodological limitations and data loss to follow-up that characterize Internet trials (Jardine et al., 2015). Specifically built to support medical research, ResearchKit enables highly automated data collection by utilizing key features such as: (a) streamlined informed consent processes, (b) interactive prompts that ‘nudge’ users to participate, and (c) mobile sensing technologies such as GPS, touch screen, camera, and accelerometer that collect infinitely richer data sets (Jardine et al., 2015). This project will utilize these features of ResearchKit to gather continuous data sets. First, self-report surveys will apply subjective methods to map changes in personality traits, cravings, drug use, and risk behaviours. Second, mobile sensing technologies will apply objective methods to map changes in passively-collected data. Computer algorithms will identify pattern irregularities in location (from GPS) and movement (from accelerometer) that may trigger craving and relapse events. Third, active tasks will be tailored to disrupt and change users’ habitual behaviours under semi-controlled conditions while phone sensors collect continuous data. Active tasks are subjective and objective measures in that they require user input which is passively collected by phone sensors. Three active task reminders will be sent to participants daily, requesting they exercise three personality traits outside their comfort zone: (i) a social-extraversion task will ask participants to connect with a stranger during a 20-minute stroll/walk (movement data collected by accelerometer); (ii) a stress-reduction task will instruct participants to sit in a quiet place for 10 minutes and be mindful, then look directly into the camera (heart rate data collected via camera), and (iii) a neural-plasticity task will instruct participants to compete a simple cognitive exercise on the phone screen (cognitive data collected by touch screen). Each active task will be tailored to influence the relevant trait changes necessary to support resilience to health risk: (a) positive activity interventions (PAIs) to promote PEM/E (Layous, Chancellor, Lyubomirsky, Wang, & Doraiswamy, 2011), (b) mindfulness-based stress reduction (MBSR) to promote NEM/N (Baer, 2003), and (c) life skills training (LST) to promote CON (Botvin & Griffin, 2014).
  2. The Evaluation stage (October – December 2016) will host a focus group comprising of University of Auckland students (n = 5) and mental health providers (n = 5). The initial focus group will begin with a broad overview of TraitMap, its purpose, and general functionality. Text content from the survey and informed consent features will be evaluated to confirm their cultural validity and universality. Questions will evaluate the ease at which users will engage with a coded query for drug use in the form of a weather question. For example, when asked “what was the weather like yesterday?” users will be prompted to reply “clear” for no drug use, “cloudy” for marijuana, “rainy” for alcohol, “snowy” for crack/cocaine, and “other” for other illicit drugs. This textual analysis will be followed by open-ended questions related to the suitability of the active tasks to reduce drug cravings and risk behaviours. Questions will specifically address whether people with M/SUDs may have issues with (a) continuous phone monitoring, (b) frequency of probes sent to their phone, and (c) adherence to a daily regimen of active tasks. Finally, stringent measures for patient confidentiality such as encryption methods and de-identified collected data will be evaluated. Such concerns are of paramount importance if any smartphone is lost, stolen, or sold during the trial. One month after design iterations are made, the focus group (n = 10) will be asked to download and pre-test TraitMap for 2 weeks. On completion of the pre-test, feedback will be recorded via an online survey which will inform developers of any design flaws that need correction prior to launching the pilot trial.
  3. The Pilot stage (January – June 2017) will conduct a pilot randomised controlled trial to assess the viability of TraitMap to reduce drug craving and risk behaviours in people with M/SUDs. The pilot trial will aim to recruit a broad range of people with M/SUDs from online support groups and the App Store. Consumer popularity of Apple products combined with the benefits of being listed in the App Store is likely to assist the project in gaining direct access to a diversity of user groups. A series of screening questions will correlate eligibility criteria with patient responses and thus automate screening and enrollment. Interested participants will be asked to complete a screening survey and admitted to the study only if they are >18 years of age, own an iPhone and are familiar with its use, and actively seek treatment for M/SUDs. A confirmation message will be sent to patients who do not qualify. Respondents that do qualify will complete an informed consent process via a comprehension quiz, generated PDF and email, and request for electronic signature. Participants meeting the inclusion criteria will be randomised to the TraitMap group or non-personalised control arm. Follow-up surveys at 4-, 8- and 12-week intervals will aim to identify key differences and similarities in drug craving and risk behaviours between groups.