Research reportAugmenting psychoeducation with a mobile intervention for bipolar disorder: A randomized controlled trial
Introduction
Mobile technology may extend the reach and impact of psychological interventions for people with bipolar disorder. The current availability of evidence-based psychological interventions for bipolar disorder is limited and likely worsening. For example, Olfson found a nearly 25% decline in psychotherapy participation and a significant reduction in the number of sessions attended among those who did participate in therapy among consumers with bipolar disorder between 1998 and 2007 according to a National Medical Expenditure survey (Olfson and Marcus, 2010). The rate of this decline in therapy participation outpaced that in unipolar depression. While the causes of this decline in participation are likely multiply determined, it is clear that delivery innovations are needed to improve availability and engagement in brief treatments compatible with real-world constraints.
Mobile technology offers a particularly promising platform for delivery of interventions. For instance, the rate of penetration of mobile phones is greater than 91% in the United States and increasing yearly (Duggan, 2013). Extending work in ecological momentary assessment, where naturalistically assessed behaviors, symptoms, and related experiences are repeatedly sampled over time (Shiffman, 2008), automated ecological momentary interventions leverage real-time assessments to deliver interventions that map to symptoms and risk factors as they occur in the moment (Heron and Smyth, 2010). A number of mobile health-based assessments and interventions have been piloted in bipolar disorder (Bardram et al., 2013; Depp et al., 2010; Wenze et al., 2014), although there are no randomized controlled trials reported to date to our knowledge.
We have previously described an automated ecological momentary intervention for bipolar disorder called Personalized Real-Time Intervention for Stabilizing Mood (PRISM). Briefly, this mobile intervention builds upon established psychoeducational approaches for bipolar disorder focused on self-monitoring of mood states and on planning action steps to address both symptoms and early warning signs of illness (Bauer et al., 2009, Bauer and McBride, 2003, Depp et al., 2007). To increase palatability and adherence, these action steps are phrased by the participant to capitalize upon source memory and are formatted into implementation intentions (Gollwitzer, 1999, Gollwitzer and Schaal, 1998). Implementation intentions are “if-then” statements that specify the circumstances (e.g., current state of illness), specific action/behaviors (e.g., coping strategies), and benefit of the action step (e.g., avoidance of negative outcomes). The result is an intervention that is highly personalized to both patient preferences and specific illness states or precursors, creating a framework for patients to “coach” themselves in critical moments. The inclusion of patient-developed statements into intervention content is consistent with broader literature on electronic interventions that indicate greater adherence and efficacy when compared to static and non-tailored intervention content (Chomutare et al., 2011, Schubart et al., 2011).
We have previously reported initial preliminary data from an open-trial design that collected data from 15 outpatients with bipolar disorder who were followed for 2 weeks and participated in PRISM (Depp et al., 2010). After one psychoeducation session, participants in that trial were provided a mobile device used to prospectively monitor symptoms and early warning signs. The collected data were then connected through automated software to their pre-specified implementation intentions specific to a symptom state or early warning sign. This uncontrolled trial provided initial evidence of high retention and satisfaction with this approach, and significant pre-post reductions in depressive symptoms.
We report here on a 6 month randomized controlled trial of PRISM in which 104 outpatients with bipolar disorder I or II were enrolled in a 4-session individually-adapted psychoeducational program. They were randomized to either receive: a) 10 weeks of PRISM delivered by smart phone or b) 10 weeks of paper-and-pencil mood monitoring. Participants were assessed at baseline, 6 weeks (mid-point), 12 weeks (post-treatment), and 24 weeks follow up. The primary outcome of the study was the severity of depressive symptoms, as measured by the Montgomery Asberg Depression Rating Scale, based on our pilot findings that identified a significant change in depressive symptoms (Depp et al., 2010). Additionally, we assessed the following secondary outcomes: Manic symptom severity (Young Mania Rating Scale) and functional impairment (Illness Intrusiveness Scale). We also contrasted study conditions in terms of their satisfaction with the intervention. We hypothesized that participants assigned to PRISM would experience greater reductions in mood symptoms and functional impairment than participants assigned to the paper-and pencil condition, and they would be more satisfied with the intervention.
Section snippets
Participants and recruitment
Participants were outpatients diagnosed with either Bipolar Disorder I or II who were recruited from various sources including flyers and advertisements placed online and in community residential and drop-in settings, depression and bipolar disorder self-help support groups, and outpatient psychiatric clinics in the San Diego area. To be eligible, participants needed to be: 1) aged 18 and older, 2) outpatients and currently prescribed medications for bipolar disorder, 3) free of visual or
Recruitment and sample characteristics
A total of 195 persons participated in the consent, initial diagnostic, and eligibility screen for the study (see Consort diagram), Of these persons, a total of 37 (19%) were found to be ineligible due to not having bipolar disorder or failing other eligibility criteria and 54 (28%) screened participants did not complete the baseline assessment due to lack of interest in the study or inability to be re-contacted. Of the 104 who were randomized to the study, 82 attended all four sessions of the
Discussion
This is the first randomized controlled trial, to our knowledge, that has augmented brief psychoeducation via a mobile telephone technology targeting mood symptoms in bipolar disorder. Retention was similar to that in other randomized trials of brief psychoeducational interventions for bipolar disorder (Eker and Harkın, 2012; Parikh et al., 2012), and the satisfaction feedback from participants was quite positive in regard to the perceived utility of the mobile device in managing symptoms.
Role of funding source
This study was financial supported by National Institute of Mental Health Grants MH091260 and MH100417 (Dr. Depp).
Conflict of interest
Dr. Granholm has received consulting fees from Otsuka America. None of the authors has any conflicts of interests to report.
Acknowledgment
The authors would like to thank the volunteers who participated in this study and Rebecca Daly and Ashley Cain for assistance with data management and project implementation.
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