Evaluating the use of digitally enhanced treatment models in early intervention for youth with bipolar disorder.

BLEND: BipoLar Early intervention using New Digital technologies (BLEND) is a multi-component, blended digital model of care designed to improve symptomatic outcomes for youth in the early course of BD. This model combines (i) evidence-based pharmacotherapies for acute and maintenance treatment of BD, (ii) psychological therapy for BD delivered through in-person individual therapy sessions blended with digital intervention content, as well as (iii) a digitally supported relapse monitoring strategy, in addition to routine care. (i) Evidence based and tolerable pharmacotherapies delivered in a shared decision making paradigm: This component includes psychiatrists offering evidence based recommendations for acute and maintenance treatment in bipolar disorder in 2-3 sessions over 4 months using a shared decision making paradigm. In the BLEND arm, psychiatrists will recommend the use of newer and more tolerable atypical medications such as lurasidone and aripiprazole, in addition to TGA approved and PBS subsidized guideline concordant medications. (ii) Blended psychological therapy includes both in-person psychological therapy as well as digital psychological interventions targeting bipolar disorder. For each young person, a clinical psychologist/mental health clinician will provide manualised and formulation driven cognitive behaviourally informed therapy based on a locally developed intervention for young people experiencing bipolar disorder. The therapist will also facilitate engagement with digital psychological therapy content (embedded within and accessed through blend.most digital platform) in a blended manner. Participants in the BLEND arm will also have access to modules targeting psychoeducation for Bipolar Disorder, preventing relapses and social rhythm therapy. Interventions will be delivered via approximately 10 (50-60min) face-to-face sessions, over 4 months. Treatment fidelity will be achieved by completion of therapy fidelity checklists and regular clinical supervision. (iii) Digitally supported relapse monitoring: Those in BLEND will also receive access to a weekly self-rating tool implemented within the MOST platform which includes a) the Altman Self-Rated Mania Scale, b) items from the Quick Inventory of Depressive Symptomatology, and c) self-assessment of need for additional care. This weekly self-rating tool is supported by SMS prompts, and responses will be forwarded to BLEND clinicians able to respond via established relapse prevention plans. Routine care includes 1) Needs based interventions to respond to acuity or changes in risk. This may include (i) Additional appointments with a psychiatrist, therapist, or peer support worker, (ii) Additional phone check-in/monitoring from therapist or peer support worker, or (iii) Changes to medication. 2) Access to Moderated Online Social Therapy (MOST): The MOST platform is an interactive, purpose-built, online platform designed to deliver a range of evidence-based and interactive psychosocial interventions. The modules targeting depression, anxiety, social functioning, and vocational functioning are available for all young people irrespective of whether they are in BLEND or Enhanced Standard Care. The platform also includes an online social networking environment, which is moderated by peer support workers. Participants are able to access psychosocial interventions on MOST 24-hours per day, 7 days per week from any internet-enabled device for the 6 months of the study period. 3) Peer Support interventions: Participants in both arms have access to dedicated peer support workers through the MOST platform. They can message peer support workers, engage with them through posts online, or organise telephone contact. Pharmacotherapeutic interventions will be monitored through regular appointments with psychiatrists and research assistants. Psychiatrists will monitor self-reported efficacy, , tolerability, and medication adherence, documenting these details in the medical record. Every two months, participants will complete assessments with research assistants. Prior to assessments, RAs will check medical/trial records to identify current prescribed trial medications. RAs will then in each appointment assess the participant’s use of each prescribed medication including (i) how many times a prescription has been filled, (ii) batch numbers for each prescription filled, (iii) frequency of having missed prescribed medication, and (iv) duration of taking each medication at each dose. Finally, Attitudes and behaviour related to medication adherence are also captured through the self-report measure Medication Adherence-Rating Scale (MARS) which is administered at Baseline and 2,4,6, and 8-months post-Baseline assessment.