Bipolar Early Intervention Using New Digital Technologies (BLEND): A Pilot Randomised Controlled Trial of a Novel Blended-Digital Early Intervention Model of Care for Youth With Bipolar Disorder I or II.

Background: Despite evidence for early interventions for bipolar disorder (BD), there are relatively few accessible treatment models. We developed a digitally augmented model of care termed BLEND (BipoLar early interventions using New Digital technologies) which aims to improve mood symptoms in BD. BLEND includes: (a) guideline-concordant pharmacotherapy; (b) in-person psychological therapies blended with digital therapeutic content and (c) digital relapse monitoring. The aim of this study was twofold: (i) describe the acceptability, safety and feasibility of delivering BLEND and (ii) examine the feasibility of an efficacy trial of BLEND compared with enhanced standard care (ESC).

Method: We conducted a parallel-group, open-label, 2:1 randomised pilot trial within a youth mental-health outpatient service in Melbourne, Australia. We included youth aged 15-25 years with BD I or II, who had not previously accessed multidisciplinary care. All participants received similar background care. BLEND differed from ESC in having manualised blended digital and in-person psychological therapies and digital relapse monitoring.

Results: We randomised 21 young people over a 12-month recruitment period, predominantly female participants (71.4%) with BD Type II (85.7%). Both treatment models were acceptable and safe, but the BLEND group had greater reductions in suicidal ideation. Among components of BLEND, in-person psychological therapy and psychopharmacological interventions could be delivered with fidelity. Digital therapy engagement was high, but participants used digital relapse monitoring variably.

Conclusions: The BLEND model was safe and acceptable and may lead to improvements in suicidality compared with ESC. Concordant with the aims of a pilot study, there is scope for the content to be rationalised based on feedback to improve feasibility of the digital therapy. Relapse monitoring may usefully be extended to depressive symptoms. The next step is to confirm the efficacy of BLEND compared with standard care.