Abstract and Introduction
Psychosocial interventions for serious mental illness are resource intensive and poorly accessible. Brief interventions (eg, single session) that are augmented by follow-on automated mobile health intervention may expand treatment access. This was a randomized single-blind controlled trial with 255 individuals diagnosed with schizophrenia or bipolar disorder. Participants were randomized to one of three conditions: CBT2go, which combined one individual session of cognitive behavioral therapy with automated thought challenging/adaptive behavior delivered through mobile devices; Self-Monitoring (SM), which combined single-session illness psychoeducation with self-monitoring of symptoms; and treatment-as-usual (TAU). Participants were assessed at baseline, 6 weeks (midpoint), 12 weeks (posttreatment), and 24 weeks (follow-up) with our primary outcome global psychopathology (Brief Psychiatric Rating Scale–expanded version [BPRS-24]), and secondary outcomes community functioning (Specific Level of Function; SLOF) and defeatist performance beliefs (DPBs). We also collected data on adverse events. Outcome analyses on the primary outcome, BPRS Total score, indicated a significant time (0–24 wk) by group interaction with significant but modest improvement comparing two active conditions (CBT2go and SM) relative to TAU. Effects of CBT2go were not different from SM. There was a significant time × group interaction with better SLOF scores in CBT2go across 24 weeks, but not in SM. There were no time-by-group effects on DPBs. DPBs decreased in the CBT2go condition but not in SM. These results indicated that single intervention augmented by mobile intervention was feasible and associated with small yet sustained effects on global psychopathology and, when inclusive of CBT, community function compared with usual care.
Limited access to evidence-based interventions for serious mental illnesses (SMI; schizophrenia, bipolar disorder) has resulted in efforts to create brief or low-intensity interventions to expand reach of treatments including through mobile technology.[2,3] Rates of mobile device usage and ownership in SMI are increasing, and mobile health interventions are of interest to the population.[5,6] Moreover, despite concerns raised over the quality of extant clinical trials, reviews have generally indicated positive impact on symptoms.[7,8] Although one meta-analysis suggested differential impact across design features, a few studies have experimentally tested variations in mobile intervention content or whether treatment effects are sustained after acute phases of intervention. To address these gaps, we conducted a randomized controlled trial (RCT) contrasting two types of single-session interventions augmented by mobile health: cognitive behavioral therapy (CBT) vs illness education with self-monitoring.
In a previous trial in bipolar disorder, we found greater impact on depressive symptoms when a 4-session psychoeducation intervention was augmented by mobile intervention compared with psychoeducation alone, immediately posttreatment. Although that trial supported mobile augmentation, there are a variety of design considerations for mobile health interventions[10,11] that can impact the user, time for personnel delivering the intervention, and the cost and complexity of deployment. Moreover, mounting evidence indicates mobile applications are associated with a steep decline in engagement following initiation. Our prior trial found attenuation of effect of mobile augmentation 12 weeks after active encouragement of device use. Finally, mechanism of change in mobile intervention is poorly understood, such as whether self-monitoring by itself may affect change (as in other behaviors) or if therapeutic elements that draw from evidence-based interventions such as CBT are impactful beyond self-monitoring. A recent proof-of-concept trial evaluated CBT vs self-monitoring content in schizophrenia in early psychosis and found positive impact of CBT compared with self-monitoring on psychotic symptoms. That trial, although highly promising, did not include a treatment-as-usual (TAU) condition and was sized to be focused on feasibility and acceptability rather than outcomes.
Few studies have evaluated the impact of design features on mechanisms. Defeatist beliefs are an intervention target for CBT in psychosis and may be useful in disentangling the impact of CBT vs self-monitoring.[15,16] A recent meta-analysis of the relationship between defeatist attitudes found consistent associations with negative symptoms and functioning but with small effect sizes, because multiple factors contribute to poor functioning. The relationship, however, is sufficiently robust such that we found improvement in defeatist attitudes in cognitive-behavioral social skills training (CBSST) significantly mediated improvements in negative symptoms and functioning, and participants with more severe defeatist attitudes showed significantly greater improvement in functioning in CBSST.[17–19]
We developed a single-session in-person intervention called CBT2go augmented by mobile interactions for SMI. Building from prior work,[9,20] this intervention integrated in-person training with mobile frequent assessment of self-management targets (ie, current mood symptoms or voices, socialization, and medication adherence), related defeatist beliefs (eg, lack of perceived control of symptoms), and adaptive beliefs and behaviors. We developed a Self-Monitoring (SM) alternative, in which in-person content concerned psychoeducation and resources pertinent SMI, and mobile interaction only involved self-monitoring without CBT elements. CBT2go and SM were contrasted to a TAU condition. The primary outcome was change in global psychopathologic symptoms and the secondary outcomes were functioning and defeatist performance beliefs (DPBs). We hypothesized that the two mobile interventions would result in significant decreases in symptoms and improvements in functioning compared with TAU and that the CBT2go intervention would result in greater improvements than the SM condition.
Schizophr Bull. 2019;45(4):752-762. © 2019 Oxford University Press