RCT of a Web-based Intervention to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT)
Condition: Bipolar Disorder, Currently in Remission
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The aim of this study is to improve outcomes in people with bipolar disorder (BD) by
      comparing two new online interventions specifically designed to improve quality of life
      amongst people who have had multiple (10 or more) episodes of BD.
    

Detailed description: 
      People who have had significant experience with bipolar disorder (defined here as 10 or more
      episodes) may not benefit from existing psychosocial interventions targeting symptoms and
      relapse, and may be better served by interventions targeting quality of life (QoL). Our
      international team of researchers, clinicians and consumers has developed two different
      online interventions, both of which there is reason to believe will be useful. Both
      interventions are brief, with 4 weeks of new online content released weekly, plus one
      additional week of application. This 5-week 'active phase' is supported by email contact with
      a personal online coach. The remainder of the 6 months of participant involvement in the
      trial includes continued access to the website (without coaching support) and follow-up
      assessments. Both arms are equivalent in using cutting-edge internet technologies and design
      features to help people engage with the therapeutic content and generalise it into their real
      lives. The websites have been developed following best-practice principles of persuasive
      system design, and rely heavily on consumer videos, social engagement through discussion
      boards, personalised feedback, and intuitive content structure to maximise engagement.

      Australia's NHMRC has funded a 4-year project (2016-2019) to develop and compare the
      effectiveness of the two websites in terms of a range of outcomes, primarily QoL. The
      randomized controlled trial (RCT) will definitively assess the QoL benefits of two websites
      for late stage Bipolar Disorder. The RCT has been designed to optimise various aims: minimise
      risk of bias to support definitive scientific findings (internal validity), support ready
      dissemination should outcomes be positive (external validity, end-user involvement), and to
      optimally manage the risks inherent in the population being studied. We expect to find
      definitive evidence of the comparative QoL benefits of the two interventions, and insights
      about secondary outcomes including self-rated state anxiety, self-rated depression, and
      clinician-rated depression. A number of clinical and functional secondary outcomes will also
      be explored, as will hypothesised mediators and baseline moderators of QoL outcomes. Economic
      analysis based on cost-consequence analysis, and a range of process evaluations will also be
      conducted.

      A total of 300 participants will be block randomised to provide power to identify a
      small-moderate treatment effect on QoL. Participants will be blinded as to the experimental
      intervention. The study uses a single-site (internet-based) design, with advertising
      occurring primarily online, but also through traditional methods via clinical networks of the
      researchers in Australia, United Kingdom (UK), Canada and the US. Major assessment time
      points are baseline, post-treatment (primary endpoint), 3 months post-baseline and 6 months
      post-baseline. Participants will be remunerated for assessments, which include both online
      questionnaires and a (blinded) semi-structured clinical interview by phone.

      A multi-layered risk-management approach has been developed based on our experience with
      online interventions for bipolar disorder and psychosis. First and foremost, we explain to
      participants that their participation does not replace usual care, and no emergency
      assistance is available through the website (a link to the international site unsuicide is
      provided). This devolving of responsibility to the participant is reinforced by the inclusion
      criterion of being under the care of a medical practitioner and having access to local
      emergency services. Second, both intervention sites contain general information about the
      potential risks (e.g., generating distress) of the interventions, as well as specific alerts
      to the potential challenges of particular exercises. Third, a comprehensive 'red flag
      decision tree' has been developed to guide the team's response to any risk issues arising
      (see Table 2). Finally, any adverse events arising will be reviewed weekly in the trial
      executive committee.
    

Intervention name(s): Mindfulness for Bipolar; Psychoeducation for Bipolar
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief online self-management program with email coaching support; Brief online self-management program with email coaching support
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a prospective, parallel group, rater-blind, superiority RCT with a 1:1 allocation ratio comparing two websites designed to improve QoL in late stage bipolar disorder. Follow-up time points are immediate post-treatment (primary outcome timepoint), 3-month and 6-month follow-ups. To minimise the risk of bias, we are not publicising which arm is expected to be superior in terms of the primary outcome. Note that we expect that both arms will lead to QoL benefits, and the statistical analysis plan is agnostic about the superiority of the experimental intervention over active control on a number of secondary outcome variables. In both arms, usual management will continue throughout, with medication and psychosocial intervention changes monitored at follow-up interviews. The study setting is online, and participation in both arms will be through a secure server at Swinburne University's National eTherapy Centre (NetC).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: stage; online; self-help; coaching support; quality of life; mindfulness; psychoeducation; persuasive systems design; psychosocial