Improving treatment decision-making in bipolar II disorder: a phase II randomised controlled trial of an online patient
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RESEARCH ARTICLE
Open Access
Improving treatment decision-making in bipolar II disorder: a phase II randomised controlled trial of an online patient decision-aid Alana Fisher1,2* , Rachael Keast1,3, Daniel Costa1, Louise Sharpe1, Vijaya Manicavasagar4, Josephine Anderson4 and Ilona Juraskova1,3
Abstract Background: Many patients with bipolar II disorder (BPII) prefer to be more informed and involved in their treatment decision-making than they currently are. Limited knowledge and involvement in one’s treatment is also likely to compromise optimal BPII management. This Phase II RCT aimed to evaluate the acceptability, feasibility, and safety of a world-first patient decision-aid website (e-DA) to improve treatment decision-making regarding options for relapse prevention in BPII. The e-DA’s potential efficacy in terms of improving quality of the decisionmaking process and quality of the decision made was also explored. Methods: The e-DA was based on International Patient Decision-Aid Standards and developed via an iterative codesign process. Adults with BPII diagnosis (n = 352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations. Participants were randomised (1:1) to receive standard information with/without the e-DA (Intervention versus Control). At baseline (T0), post-treatment decision (T1) and at 3 months’ post-decision follow-up (T2), participants completed a series of validated and purpose-designed questionnaires. Self-report and analytics data assessed the acceptability (e.g., perceived ease-of-use, usefulness; completed by Intervention participants only), safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA (% accessed). For all participants, questionnaires assessed constructs related to quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes). (Continued on next page)
* Correspondence: [email protected] 1 The University of Sydney, The School of Psychology, Sydney, NSW 2006, Australia 2 The University of Sydney, The Matilda Centre for Research in Mental Health and Substance Use, Sydney, NSW 2006, Australia Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need
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