Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol

Abstract

BackgroundThe primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (≥ 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support.Methods/designThis international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored.DiscussionThis definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action.Trial registrationClinicalTrials.gov: NCT03197974. Registered 23 June 2017.Electronic supplementary materialThe online version of this article (10.1186/s12888-018-1805-9) contains supplementary material, which is available to authorized users.

Number of episodes in bipolar disorder: The case for more thoughtful conceptualization and measurement

“…Additionally, across various studies, differing definitions of NoE and of episode‐related constructs have been used. For example hypomania has been variously defined as periods of at least 2 days to at least 7 days, whereas others fail to report whether mixed or hypomanic episodes have been included when reporting NoE, with such differences potentially influencing conclusions. Changes within major diagnostic classification systems also have the potential to influence episode classification and counts.…”

“…For example some respondents may focus only on those episodes which led to hospitalization, and timeline‐based prompts may assist with recalling other episodes. These examples are based on the methods employed in two recent RCTs for which NoE was an inclusion criterion, however they have not been validated . In addition, given the potential for distress associated with the recall of mood episodes, advising respondents about this potential and ways to manage this (such as ceasing the assessment), while monitoring the impacts of the assessment is recommended (see Appendix B).…”

Toward New Therapeutic Mechanisms in Bipolar Disorder: Analog Investigation of Self-Compassion and Nonattachment to Self

“…First and foremost, statistical mediation in a cross-sectional convenience sample quantified by their degree of self-reported vulnerability to BD is simply a first step in investigating putative therapeutic mechanisms at the level of self-concept in BD. As part of a large clinical trial, our group is currently testing whether therapy-related improvements in self-compassion and nonattachment to self correlate with improvements in quality of life and symptoms in late stage BD ( Fletcher et al, 2018 ). Second, self-compassion and nonattachment to self were assessed by self-reported measures, susceptible to response biases.…”

Web-Based Self-Management Programs for Bipolar Disorder: Insights From the Online, Recovery-Oriented Bipolar Individualised Tool Project

“…The aim of this paper is to accelerate progress toward the next generation of Web-based interventions by critically reviewing the experience of one, very particular, Web-based treatment development process. The overarching aim of the Online, Recovery-Oriented Bipolar Individualised Tool (ORBIT) project was to develop and test a Web-based self-management intervention for people with bipolar disorder (BD) to improve their quality of life [ 8 , 9 ].…”

“…The trial (registered 23 June, 2017, ClinicalTrials.gov: NCT03197974) is funded by the Australian National Health and Medical Research Council and was reviewed and approved by Swinburne University of Technology Human Research Ethics Committee (2016/289). As detailed in the protocol paper [ 9 ], recruitment is primarily via open social media sites (eg, International Bipolar Foundation Facebook site). Main inclusion criteria are as follows: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of ≥10 mood episodes, no current psychotic features or active suicidality, and under the care of a medical practitioner.…”