This document summarizes lessons learned from involving consumers in three randomized controlled trials (RCTs) of adjunctive psychosocial interventions for bipolar disorder. It describes how a Consumer Advisory Group provided input that shaped the priorities, ethical decisions, and design of an ongoing RCT trial called ORBIT. Specifically, the group helped identify quality of life as an important outcome to assess, emphasized autonomy in intervention delivery, and provided feedback that improved online intervention videos and engagement. While consumer involvement increased the rigor and relevance of the research, it also introduced challenges like balancing diverse perspectives and managing risks when working with sometimes unwell participants. Overall, the experience highlighted the value of incorporating consumer voices and expertise into mental health intervention design and trials.

1. Consumer Engagement in Research:
Lessons Learned From Three RCTs
ORBIT
ORBIT Research Project Team

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3. Today’s talk
• Consumer involvement in ongoing ORBIT project
– Setting priorities
– Ethical decisions
– Intervention design: principles and process
• Impact of community participation?

4. Ongoing clinical trial following community-based
participatory research principles
Balazs & Morello-Frosch, 2013

5. Scientific background
• Adjunctive psychosocial interventions effective in BD, but
modest effect sizes encourage innovation (Geddes & Miklowitz,
2013)
• Growing interest in ‘staging’ (Berk et al, 2007; Muneer, 2016)
• People with significant bipolar disorder experience may not
benefit from current adjunctive psychological interventions
(Scott et al, 2006)
• In this population, focus on relapse prevention may be less
useful than focus on improving quality of life (Murray et al, 2015)

6. Community involvement to identify
questions to ask and outcomes to assess
• Existing consumer based network, existing priorities, relationships,
processes (CREST.BD)
• 2013: Discussions with Canadian Community Advisory Group
– Where to next for adjunctive psychological therapies in bipolar disorder?
– Growing consumer interest in ‘third wave’ psychological therapies, self-
management, low intensity online interventions
– Researchers introduce staging notion
– Existing research into patient-valued outcome Quality of Life (QoL.BD, Michalak
& Murray, 2010)
• Successful pilot study investigating prototype brief online
mindfulness-based intervention for ‘late stage’
bipolar disorder(Murray et al, 2015)
• 2015: NHMRC funds 4-year RCT

7. Ethical decisions
• Risk management in remote delivery of adjunctive
psychological interventions
– Previous ISBD discussions
• What is the role of the consumer, their local
professionals/services, the website and researchers?
– “I’ve been looking after myself with bipolar for decades…don’t
helicopter”
– “You’ve just gotta suck it up, Greg”
• Autonomy as an ethical priority

8. Intervention design and delivery
• Builds on existing CBPR in online interventions for serious
mental disorder (SMART project, Thomas et al, 2016)
• Maximising engagement, empowerment, autonomy
– Content delivered by consumers, in their own words
– Discussion forums
– Trial participants comment on videos, etc.
– Forums seeded, moderated by trained and supervised
consumer experts (‘Superusers’)

9. Website development process
• Static elements, structure, pedagogical approach, onsite versus offline practice
– CAGs feedback on ‘how would that work for you?’
– Less text, simpler language, chunk content, shorter videos, Australian
accent OK
• Video elements
– Develop therapy content
– Identify multiple consumers with relevant lived experience
– Develop interview questions
– Film videos
– Edit videos for content coverage
– Review therapy content
– Seek CAG feedback on draft videos
– Repeat for 18 months
• Recursive review of static and video elements
• CAG members trial site for useability, provide written feedback

10. Ongoing ORBIT trial
• 2016-2019: RCT comparing two low-intensity approaches to
maximising quality of life in late stage bipolar disorder
– Contrasting content
– Identical engagement features
– Adjunctive online self-help intervention with email
coaching support
• Single-site (internet) study
– International recruitment, ethical approval through
Swinburne University HREC

12. What impact has consumer involvement
had on ORBIT?

13. Not without its challenges…
• Working with people who are sometimes unwell brings
complex management and ethical decisions
• Alternative voices makes decision-making less straightforward
• ‘Consumers’ no more homogeneous than any other group
• Developing documentary-style videos for content delivery is
time-consuming, expensive
• Participant involvement in the intervention (online comments,
participation in forums) adds uncontrolled element to design

14. Benefits
• Rigor achieved through greater range of voices
• Web engagement efforts seem to have worked
• Recruitment progressing on target
• Collecting participant feedback to refine intervention and
future online delivery
• New relationships developed, access to new expertise for
future research
– Skills of our discussion board moderators
– Expert patients emerge as future collaborators
– International Bipolar Foundation, Bipolar Life, Melbourne
CAG

15. Is consumer involvement worth it?
• Concerns about the validity of evidence for the benefits of
consumer involvement in research (Staley, 2015)
– Document instances of changes from original researcher
position?
– RCT of which video maximises recruitment?
• Researchers’ experience in context is key data
– The researcher is the subject of the question ‘Is consumer
involvement worthwhile?’

16. Light bulb moments for the chief investigator
• “Well, what was it like for you, Greg?” (Sara Lapsley)
• Autonomy as a core ethical principle, operationalised in clear
communication about risk management
• Experience of altruism and humility
• Giving consumers a voice in the intervention deepens the
intervention

17. ORBIT Research Project Team
Investigators
Greg Murray Swinburne
Erin Michalak UBC
Michael Kyrios ANU
Sheri Johnson UC Berkeley
Steven Jones Lancaster U
Neil Thomas Swinburne
Cathy Mihalopoulos Deakin
Michael Berk Deakin
Lesley Berk Deakin
Sara Lapsley UBC
Tania Perich UWS
Susan Cotton U of Melb
Steven Bowe Deakin
Project Manager
Fiona Foley
Research Staff
Kathryn Fletcher
Katrina Lindblom
Kerrie Salsbury
Summer Guo
Postgraduate Students
Hailey Tremain
Yan Yang
Nancy Georgie
Software Developers
Media Insights
Multimedia Developers
Rybazoid
Consumer Reference Group
Peer Educators
Forum Moderators
Currently recruiting www.orbitonline.org