Serious mental illness (SMI), such as schizophrenia and bipolar disorder, affects approximately 4% of the US population and profoundly affects individuals, their families, and communities. Mobile Health (mHealth) approaches that use mobile phones in support of health care can help overcome some of the barriers associated with clinic-based care. Whether mHealth interventions can serve as standalone treatments, effectively engage individuals with SMI in remote care, and produce clinical outcomes that are comparable to clinic-based interventions is unknown.
mHealth approaches that use mobile phones to deliver interventions can play an important role in improving access to care for people with serious mental illness. The goal of this study was to evaluate how an mHealth intervention (FOCUS) performs against a traditional group-based treatment (Wellness Recovery Action Planning [WRAP]). The specific aims of the study were to (1) evaluate and compare the willingness and ability of individuals with SMI to enroll in the 2 illness self-management interventions, (2) examine and compare participant engagement and satisfaction with both treatments, and (3) examine and compare patient outcomes following participation in the interventions.
We conducted an assessor-blind, 2-arm, randomized controlled intervention superiority trial between June 2015 and September 2017 in partnership with Thresholds, a large community mental health agency that provides services to people with serious mental illness living in the Midwestern United Sates. The participants were 163 predominantly minority clients with long-term, serious mental illnesses (49% with schizophrenia/schizoaffective disorder, 28% with bipolar disorder, and 23% with major depressive disorder). The outcomes were engagement throughout the intervention period, satisfaction posttreatment, and improvement in clinical outcomes (assessed at baseline, posttreatment, and 6-month follow-up). Our primary clinical outcome was general psychopathology, which is most appropriate for the range of clinical groups represented in the sample of people with serious mental illness. Secondary clinical outcomes included depression, psychosis, recovery, and quality of life. Individuals were randomized (1:1 ratio) into FOCUS (n = 82) or WRAP (n = 81). Interventions were deployed for a period of 12 weeks, using cycles of 8 cohorts of participants assigned to individual FOCUS or group-based WRAP over parallel periods. Participants were not monetarily incentivized to engage in interventions but were compensated for completing assessments. The study was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02421965).
Participants assigned to FOCUS were more likely to commence treatment (90% vs 58%) and remain fully engaged in 8 weeks of care (56% vs 40%) than those assigned to WRAP. Patient satisfaction ratings were comparably high for both interventions. Participants in both groups improved significantly and did not differ on clinical outcomes, including general psychopathology and depression. We saw statistically significant improvements in recovery within the WRAP group posttreatment, and we saw significant improvements in recovery and quality of life within the FOCUS group at 6-month follow-up. There were no statistically significant differences between groups in retention of gains over time.
Both the FOCUS and WRAP interventions produced significant gains in predominantly minority clients with severe and persistent mental illnesses. The mHealth intervention (FOCUS) showed superior treatment commencement and patient engagement and produced patient satisfaction and clinical outcomes that were not statistically different from those produced by a widely used clinic-based group intervention for illness management (WRAP). If clinicians or patients are given the option to select from these 2 treatment options, the findings of our research can directly inform their decision-making. Broadly, this study supports the notion that mHealth can play an important role in 21st century mental health care. Contemporary mobile phone “smart” functionalities enable these devices to serve as much more than staid information repositories. Audio and video media players, graphics displays, interactive capabilities, bidirectional calling and texting, and internet connectivity create new opportunities to engage patients with both automated resources and human supports. Policymakers contemplating whether mHealth should be recognized as a viable (and potentially billable/reimbursable) service will be encouraged to see our findings, which suggest that some mHealth interventions warrant consideration, as they produce outcomes that are comparable to more time-/labor-/resource-intensive clinic-based care.
We did not include a usual-treatment comparator arm. We are unable to conclude that the clinical outcomes reported in the study are a direct result of the interventions deployed, rather than the passage of time, artifacts related to involvement in research, or treatment from outside the research. We developed measures of engagement and satisfaction for this study that have not been evaluated and validated in previous research. Because the study was powered to detect differences in the full sample between treatment groups, exploratory analyses have reduced power and thus should be interpreted with caution.
