Participants were recruited from March 2015 to March 2016 from a variety of sources including the Minnesota-based health care system, HealthPartners, online (eg, ResearchMatch, Craigslist, Reddit, clinicaltrials.gov, social media advertising) and community (eg, print advertisements posted on public transportation, media) advertising, and clinical research registries. Recruitment materials informed participants that the study was examining the use of mobile phone apps to teach self-management skills for depression and anxiety.
Participants were included in this single-arm field trial if they exhibited depressive symptoms indicated by a score of 10 or higher on the Patient Health Questionnaire-9 (PHQ-9) [33 (link)], or anxiety symptoms indicated by a score of 8 or higher on the Generalized Anxiety Disorder-7 (GAD-7) questionnaire [34 (link)]; were 18 years of age or older (age 19 if in Nebraska, given age of consent); could speak and read English, living in the United States; and owned and were familiar with an Internet-ready Android mobile phone with data and text plans. The PHQ-9 and GAD-7 closely match the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder and generalized anxiety disorder, respectively. Furthermore, these measures are widely used in primary care settings and useful for identifying and monitoring depression and anxiety in clinical and general populations [35 (link)-37 (link)]. Thus, these inclusion criteria are similar to what might be expected to identify people at need for real-world deployments of similar treatment options. Participants were excluded if they had any visual, hearing, voice, or motor impairments that would prevent completion of study procedures; met diagnostic criteria for a severe psychiatric disorder (eg, bipolar disorder, psychotic disorder, dissociative disorder) or any other diagnosis for which this trial was either inappropriate or dangerous; exhibited severe suicidality including having ideation, a plan, and intent; had initiated or changed antidepressant or antianxiolytic pharmacotherapy in the previous 14 days; or had used any of the IntelliCare apps for more than 1 week in the last 3 months.
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