None listed
Conditions
Brief summary
A diagnosis of bipolar II disorder is commonly accompanied by a need to make complex treatment decisions about medications and adjunctive psychological therapies, often for lifetime prophylactic (preventative) use. However, people with bipolar II disorder are often reluctant to commence and adhere to effective medications long-term, mostly due to lack of knowledge, less-than-desired involvement and preference for treatments other than those prescribed, which can worsen the course of their illness. Research shows that many people with bipolar II disorder, especially those with a recent diagnosis, prefer a more active role in their treatment decisions than they currently have, and may have greater unmet decision-making needs than those with a longer-standing diagnosis. Yet, there is currently no resource that might facilitate this involvement. This project aims to build on our comprehensive research program targeting bipolar II disorder treatment decision-making by evaluating the world’s first, evidence-based online decision-support resource, a decision-aid website, for patients with bipolar II disorder and their family who are deciding on treatment options for relapse prevention. In this Phase II randomised control trial, a consecutive patient sample (n=60) aged 18+ and with a confirmed clinical diagnosis of bipolar II disorder will be recruited through the Black Dog Institute and randomised (1:1) to receive either usual care with or without the decision-aid. At baseline, immediately post-treatment decision and at 3 months' follow-up, we will assess, via validated and purpose-designed questionnaires, the decision-aid's potential efficacy at improving key aspects of decision-making quality. We expect that the DA will: i) reduce patients' uncertainty and regret in decision-making, ii) empower them to feel more informed and supported in decision-making, iii) help clarify their values regarding for treatment for bipolar II disorder, iv) improve their knowledge about treatment options/outcomes, v) help them to be involved in treatment decision-making to the extent desired, and vi) improve their uptake of effective medication and psychological treatments.
Interventions
Treatment decision-aid intervention: This decision-aid website for bipolar II disorder, developed by PI Juraskova, CIs and professional web designers/developers, has been informed by: best available clinical evidence; extensive qualitative interviews with key stakeholders (patients [n=28], family [n=13], and clinicians [n=20]) (Fisher et al., 2017a; 2017b; 2017c); iterative review by an expert advisory group (decision-aid experts, patients with bipolar II disorder, their family and treating clin
Treatment decision-aid intervention: This decision-aid website for bipolar II disorder, developed by PI Juraskova, CIs and professional web designers/developers, has been informed by: best available clinical evidence; extensive qualitative interviews with key stakeholders (patients [n=28], family [n=13], and clinicians [n=20]) (Fisher et al., 2017a; 2017b; 2017c); iterative review by an expert advisory group (decision-aid experts, patients with bipolar II disorder, their family and treating clinicians); and International Patient Decision Aid Standards (IPDAS). It provides evidence-based, non-directional information, which has been professionally-copy edited for low health literacy levels. The decision-aid explains main available medication and psychological treatment options for relapse prevention in bipolar II disorder, based on available guidelines; with specific sections for patients’ family. Lay information is presented using text and graphics on the rationale for, efficacy and known benefits/costs of each treatment option. Interactive values clarification exercises are included to assist patients/family to consider their preferences and deliberate on the benefits/costs of the different treatment options. The decision-aid website can be accessed by the patient participant and/or family member at any frequency and duration in the period following diagnosis and leading up to follow-up consultation/s with their managing psychiatrist, GP and/or clinical psychologist. The website will be used for informed treatment decisions insofar as it is designed to increase patients' knowledge about their main available treatment options and guide them through a deliberate process of weighing up the "pros" and the "cons" of options in line with their personal values and preferences (via the interactive, values, clarification exercises). Patients (and their families) will have the option to save/print their values clarification responses and take these along to follow-up consultations with clinicians to serve as a "conversation starter". Adherence to the intervention will be tracked via Analytics software (e.g., page views, time spent on page, downloads etc.). Moreover adherence/fidelty will be maintained via "essential reading sections"; these are information sections of the website that will need to be consulted before the participant can proceed to the values clarification exercises and completion of the questionnaires. Fisher A et al. (2017a). A qualitative exploration of patient and family views and experiences of treatment decision-making in bipolar II disorder. Journal of Mental Health (Epub:13 January 2017). doi: http://dx.doi.org/10.1080/09638237.2016.1276533 Fisher et al. (2017b). A qualitative exploration of clinician views and experiences of treatment decision-making in bipolar II disorder. Community Mental Health Journal (Epub: 19 January 2017). doi: 10.1007/s10597-016-0077-4 Fisher A et al., (2017c) Identifying and addressing barriers to treatment decision-making in bipolar II disorder: Clinicians’ perspective. Australian Psychologist (Epub: 14 February 2017) doi:10.1111/ap.12264.
Sponsors
A/Prof Ilona Juraskova
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
i) Confirmed clinical diagnosis of bipolar II disorder; ii) Out of acute episode of depression and/or hypomania (i.e., subsyndromal or euthymic); iii) Actively considering treatment options for relapse prevention in bipolar II disorder with a clinician (e.g., GP, psychiatrist or clinical psychologist).
Exclusion criteria
i) Lacks English proficiency to read the decision-aid and/or complete questionnaires; ii) Lacks capacity to provide informed consent to research; iii) Comorbid substance abuse disorder; iv) Comorbid neurological or major psychiatric condition.
Outcome results
None listed