Online ethics: where will the interface of mental health and the internet lead us?
Cosgrove et al. Int J Bipolar Disord
Online ethics: where will the interface of mental health and the internet lead us?
Victoria Cosgrove 0 2
Emma Gliddon 1 3
Lesley Berk 1 3
David Grimm 2
Sue Lauder 3
Seetal Dodd 1 3
Michael Berk 1 3
Trisha Suppes 0 2
0 Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine , 401 Quarry Road, Stanford, CA 94305 , USA
1 IMPACT Strategic Research Centre, Deakin University , Geelong , Australia
2 Bipolar and Depression Research Program, VA Palo Alto Health Care System , Palo Alto , USA
3 Department of Psychiatry, University of Melbourne , Parkville , Australia
While e-health initiatives are poised to revolutionize delivery and access to mental health care, conducting clinical research online involves specific contextual and ethical considerations. Face-to-face psychosocial interventions can at times entail risk and have adverse psychoactive effects, something true for online mental health programs too. Risks associated with and specific to internet psychosocial interventions include potential breaches of confidentiality related to online communications (such as unencrypted email), data privacy and security, risks of self-selection and self-diagnosis as well as the shortcomings of receiving psychoeducation and treatment at distance from an impersonal website. Such ethical issues need to be recognized and proactively managed in website and study design as well as treatment implementation. In order for online interventions to succeed, risks and expectations of all involved need to be carefully considered with a focus on ethical integrity.
E-health initiatives are poised to revolutionize delivery
and access to mental health care around the world. For
example, available applications focusing on assessment or
intervention for adults with depression or anxiety
(Christensen et al. 2014; Griffiths et al. 2010)
considerable strengths such as global accessibility, reduced cost,
consumer interactivity, and potential for
(Lal and Adair 2014)
. While moving mental health
assessment and intervention online transforms the
landscape of service provision, it also warrants ethical
considerations that differ from those in traditional, in-office,
face-to-face sessions. Conducting clinical research within
online platforms delivering mental health care often
necessitates an even more careful approach to ensuring
ethical principles are upheld. While it can be argued that
delivery online involves a similar ethical framework to
face-to-face, the nuance of this is quite different in the
This paper examines the unique challenges and
ethics of overseeing a global, online clinical trial of a
self-help intervention for individuals with bipolar
disorder, MoodSwings 2.0. In clinical research studies with
high-risk populations, protecting patients and
minimizing their clinical risk are paramount to most other
concerns. While this remains true for online mental health
programs, the conceptualization of risk must be
broadened to include potential breaches of confidentiality
related to online communications (such as unencrypted
email), data privacy and security, risks of self-selection
and diagnosis as well as the shortcomings of
receiving psychoeducation and treatment at distance, from an
impersonal website rather than a human being. It is now
recognized that face-to-face psychosocial interventions,
designed to have beneficial psychoactive effects, can at
times inadvertently have adverse psychoactive effects.
This paper will present our views on the unique ethical
challenges presented by the MoodSwings 2.0 online
program for bipolar disorder, the lessons learned during our
clinical trial, and potential future ethical considerations
of online psychotherapeutic research.
Mood and the internet
A 2014 landmark study, coauthored by
representatives from the Core Data Science Team at Facebook as
well as academicians at Cornell and Princeton, showed
convincing experimental evidence that users’ moods,
measured by tendencies to post positive or negative
sentiment, could at least in part be altered by manipulating
the type and amount of emotional content in a user’s
Facebook “News Feed”
(Kramer et al. 2014)
. In other
words, website content may cogently shift and transform
mood states independent of in-person meetings and
exchanges. Simply, Facebook impacts mood.
So if online websites like Facebook that lack explicit
mood-related messages or tools still have the capacity to
shift mood, online mental health programs targeted to
clinical populations like MoodSwings 2.0 with
unequivocal psychoeducation and techniques specifically designed
to facilitate mood management may be uniquely
positioned to do so. The MoodSwings 2.0 program is an
internet-based psychoeducational and supportive
intervention for individuals with bipolar disorder, which is a
chronic and disabling condition associated with frequent
relapse and subsyndromal symptoms between episodes
of mania, hypomania, or depression as well as
significant impairments in occupational and social functioning
(Judd et al. 2008; Perlis et al. 2006)
. Its self-guided design
complements and serves as an adjunct to clinical care
from local psychiatrists, psychologists, and other
mental health professionals. The program’s content is based
on the successful face-to-face group therapy program
known as MAPS, which was adapted for online use and
became known as MoodSwings.
A previous head-to-head trial of the MoodSwings
program had promising results
(Lauder et al. 2015)
to a technological upgrade and re-launch of the program
now known as MoodSwings 2.0. The first trial compared
a basic version of MoodSwings consisting of
psychoeducational materials and asynchronous discussion boards
with a more interactive version that added skills-based
cognitive behavioral therapy tools. Both groups showed
clinically significant baseline to endpoint reductions
in symptoms of mania and depression as well as other
improvements in quality of life and functionality, and
the more interactive version was superior to the basic
version on long-term improvement in mania symptoms
at 12-month follow-up. Additionally, MoodSwings 2.0
integrated video-based content that enhanced didactic
experiences for participants whenever possible as well as
ensured that the overall program worked on a variety of
different platforms including PCs, MacIntosh, Iphones,
Ipads, and other tablets.
A number of internet-based programs have been
evaluated as adjunctive treatments for bipolar disorder
(Hidalgo-Mazzei et al. 2015; Faurholt-Jepsen et al. 2015)
Many studies have shown promising results, including
improvements in quality of life, symptom severity, social
support, and medication adherence; however, further
investigation is needed to establish the potential benefits
of these programs through controlled trials as few
programs have been evaluated against active control
conditions, noting that waitlist controls risk inflating effect
The MoodSwings 2.0 clinical trial, funded by the
National Institute of Mental Health, is an international,
randomized trial of three stepped levels of adjunctive
(Lauder et al. 2017)
(see Fig. 1). Coordination
of the clinical trial, which recruited three hundred
participants globally, was managed via a two-site international
collaboration between the Stanford University School of
Medicine in California and Deakin University in
Australia. Participants were subsequently assessed at 3, 6, 9,
and 12 months via phone calls with trained study staff
and online with standard instruments measuring mood
symptoms, overall health status, and functioning, as well
as quality of life in an effort to determine which
components of care may be most valuable.
The potential benefits for participants in programs
like MoodSwings 2.0 are considerable. Accessing
specialty care and evidence-based clinical information for
bipolar disorder often proves challenging for patients,
particularly those who may live in rural areas or have
minimal financial resources
(Zeber et al. 2009)
Consumers are often forced to seek in-person medication
management from available medical doctors who may be
excellent general practitioners but lack specialty training
in the management of serious mental illnesses such as
bipolar disorder. From the comfort of their own homes,
MoodSwings participants were able to access
psychoeducational materials vetted by worldwide experts in bipolar
disorder. Additionally, individuals interacted on
discussion boards, supported each other, and shared tips and
techniques with other individuals from around the globe
who struggle with similar mood symptomatology.
The challenge of ensuring privacy
Human subjects research projects generally must receive
approval from local ethics committees, such as
institutional review boards (IRBs) in the United States or
human research ethics committees (HRECs) in Australia
(Harriman and Patel 2014)
. The Stanford Encyclopedia
of Philosophy’s chapter on Internet Research Ethics
indicates that privacy related to an individual’s confidentiality
and anonymity as well as privacy and security of data is
both exceptionally important when considering the
ethics of conducting research on the internet (Buchanan and
Zimmer 2013). Since the global internet is by definition
a public forum, ensuring privacy is uniquely challenging
for clinical researchers.
In MoodSwings 2.0, participant’s privacy and
confidentiality were ensured in multiple ways. When a participant
first registered his or her interest in the study at http://
www.moodswings.net.au, he or she was asked to create a
user name that did not resemble their own name or other
names they may use on other websites such as discussion
forums, Facebook, or Twitter. Previous experience from
the MoodSwings 1.0 trial identified this possible issue,
and this approach to prevent cross-site contamination
was continued in MoodSwings 2.0. Further, participants
and research staff communicated exclusively via an email
messaging system that is internal to the website’s design.
Participants were prohibited from using their personal
email accounts for study communication and instead
were always redirected to the internal messaging system.
This maximized their privacy while enabling reliable and
secure conversation between participants and study staff
and is commonly used in online interventions
et al. 2011)
Participants in MoodSwings 2.0 were able to
communicate with other participants via one of three peer
Discussion Boards, moderated by a researcher,
depending on their randomization block. Here they were able
to post interactive comments with other participants
in the MoodSwings 2.0 study. While Board
moderators were primarily on call to ensure patient safety
(discussed below), maintaining privacy and anonymity was
also considered when moderating posts. Moderators read
posts with an eye toward editing out information that
could potentially identify a participant, such as physical
location (i.e., address).
Given that this trial was officially funded by two NIH
grants separately awarded to one US and one Australian
institution, formal engagement with two separate ethical
review boards (e.g., IRB, HREC) was necessary. The two
coordinating sites for the trial ensured that their local
ethics boards were tasked with both adhering to high
ethical standards for conducting research with humans as
well as reviewing and approving the same amendments
at the same time for the overall global project. However,
given the online and global nature of the project, neither
ethical entity was resourced to address legal issues that
could arise specific to any geographic jurisdiction other
than their own. Instead, the ethical review boards that
vetted this clinical trial were only able to protect factors
such as participant privacy and safety pertaining to their
own local jurisdictions—in this case, California and
A recent open pilot trial of a mindfulness-focused
intervention for late-stage bipolar disorder modeled
procuring ethical approval in one national jurisdiction
(Swinburne University, Australia) while focusing study
recruitment efforts in another (Canada)
(Murray et al.
. This seems an ideal, honest, and transparent
model for multi-national internet intervention research
initiatives. Participants can then be clearly informed in
consenting documents that the project in which they are
considering participation has been ethically vetted by
only one institution in a given geographic and legal
jurisdiction. The challenge within a consent document seems
to then become how to practically inform potential
participants that regardless they are still themselves bound
by the legal and ethical precedent in their own
Does privacy equal security?
Of course, there are obvious ethical quandaries in
confidently assuring patients of privacy when their research
involvement occurs almost exclusively in a public setting
like the internet. In some ways, as some bioethicists have
suggested, the internet and other technologies may
significantly decrease a patient’s sense of privacy
et al. 2012)
. However, other studies suggest that the
perceived potential to remain anonymous online may
actually enhance a sense of privacy and safety
(Griffiths et al.
. Findings from one study examining the safety,
privacy, and security of an online treatment for young
consumers recovering from early psychosis suggested that
patients felt safe and trusted their experience on the
(Gleeson et al. 2014)
. Since MoodSwings 2.0 collected
information about participants’ subjective experiences of
their research participation, it is similarly well-positioned
to explore subjective perceptions of privacy. It must be
noted however that a sense of privacy does not always
equate with actual security and protection of privacy.
In the United States, the Health Insurance
Portability and Accountability Act of (1996) sets standards for
Privacy and Security regarding Protected Health
Information, or PHI. Privacy and security of data in clinical
research is always a high priority. Since MoodSwings 2.0
operates on a virtual platform and collects data via the
internet, careful considerations were made to protect and
secure the data during negotiations with website
developers. The MoodSwings 2.0 program adopts many common
website security mechanisms including enterprise-based
database encryption, Transport Layer Security (TLS)/
Secure Sockets Layer (SSL) as well as disaster recovery
(Baker and Bufka 2011)
. MoodSwings 2.0 also runs
and is backed up on the Digital Ocean Solid State Drive
Cloud Server, similar to cloud servers utilized by
largescale websites such as Pinterest and Facebook.
Appropriate utilization of online resources depends in
part on a suitable match between the resource and the
participant’s problem. A challenge for online resources
is that of self-diagnosis and self-selection for treatment.
Bipolar disorder is notoriously complex to diagnose and
has many differential diagnoses. A considerable amount
of diagnostic instability characterizes all psychiatric
diagnoses. And “externalizing” diagnoses such as
bipolar disorder may be more attractive to people than some
“internalizing” diagnoses such as personality disorders.
All of this is amplified by internet resources, which rely
to a far greater extent on self-diagnosis and self-selection
than face-to-face therapy and research. This entails a
degree of risk and a corresponding ethical issue that will
be a challenge for the field to resolve. MoodSwings 2.0
used telephone interviews as a part solution to this issue,
but many online trial websites do not have the resources
to do this, and this is not feasible if the promise of
scaleindependent roll out of such resources is to be realized.
Safety Red Flags and the limits of internet interventions for mental health
The MoodSwings 2.0 Red Flag Monitoring System (see
Figs. 2, 3) was designed to identify and provide guidance
to participants who may be approaching a clinical crisis.
Although MoodSwings 2.0 was designed as an adjunct to
local clinical care, a Red Flag System provides an ethical
approach to fulfilling clinical responsibility to
participants. When a participant signed consent and enrolled in
the study, he or she was required to provide information
for an individual who could be reliably contacted during
an emergency. During regular online and phone
assessments, there were two fundamental ways to receive a
system “Red Flag.” First, scores above a validated cut-off
on various self-report or interview-based, mood-related
measures generated a Red Flag, sending an automated
internal email with instructions to the participant to
contact his or her health care provider. Most of these were
the result of elevated overall scores on ratings of
depression or mania, and in such cases study staff reassessed
mood in 7 days.
However, some Red Flags were generated as a result
of clearly expressed suicidal ideation or intent. In these
cases, a member of the study team called the participant,
and if unsuccessful at making contact, the emergency
contact. A Discussion Board Moderator also had
discretionary ability to generate a Red Flag for participants who
expressed suicidal ideation, plan, or intent via a post. In
this case, a participant was also contacted via phone.
The strengths and benefits of the MoodSwings 2.0 Red
Flag Monitoring System included its benevolent
objective to catch and help participants during clinical crisis by
encouraging them to contact local care providers. Most
of the time, the study team agreed that the Red Flag
system was helpful for participants and researchers alike.
Fig. 2 MoodSwings 2.0 Red Flag Monitoring System flowchart: self-assessment and discussion board components. Figure includes detailed model
for Red Flag Monitoring System designed to identify via routine self-report methods study participants at high risk for suicidal behavior and provide
guidance for services and care. Participants are also identified as high risk if the content of their discussion board posts is deemed concerning by
However, there were noteworthy exceptions, where its
implicit constraints should be underscored. For example,
if study staff are not able to connect via phone for many
days or at all with a participant or emergency contact,
what steps should be taken to ensure patient safety? This is
an ethical gray area connected to online interventions. For
how long should study staff continue to attempt contact?
What if a participant became agitated by the MoodSwings
2.0 automated email communication, which could occur
as frequently as once per week if he or she is mid-episode?
The identification of participants who have been
“flagged” as a result of general symptomatology or
suicidal ideation also underscores the global nature of
online internationally accessible projects as well as the
limitations of practicing “distance therapy” (DeAngeles
2012). Participants in most cases lived in localities
physically distant from Palo Alto or Geelong, the two study
coordinating sites. Study staff were unlikely to be familiar
with available crisis resources on a local level. Moreover,
local resources were often scarce. During the course of
the trial, the team sought to identify specific suicide
hotlines or services for every country represented by active
participants. For several remote countries where
participants had enrolled, this proved impossible. This issue
also underscored the difference between the quality and
depth of the therapeutic linkages and relationships
possible in online self-help forums and face-to-face trials, and
the consequent feasibility of intervention in such diverse
Managing risk: protecting the interests of the MoodSwings
2.0 clinical research team
In addition to protecting patients, the interests of
clinical researchers operating from a virtual and physical
distance must be carefully considered. For example, there
are inherent limitations when primary communication
with participants takes place via electronic modalities
such as email or discussion boards or phone-based
clinical interviews. The most important safeguard for both
the research team and participants was to emphasize
repeatedly the adjunctive nature of the MoodSwings 2.0
Program. Participants as well as members of the study
team were frequently reminded first and foremost that
the MoodSwings 2.0 program was not a substitute for
ongoing face-to-face supervision and consultation with
health care providers. Study staff were prohibited from
monitoring individual participant interaction with the
MoodSwings 2.0 program or responding in
personalized or individualized ways to participant input, except in
cases of Red Flags.
As a further ethical check, a Data Safety
Monitoring Board (DSMB) was convened specifically for
MoodSwings 2.0, composed of ethicists and
researchers from around the globe and with the sole purpose of
identifying and managing specific risks for participants.
DSMB discussions largely encompassed issues related to
patient and data privacy and security described earlier
in this opinion. DSMB members have also discussed the
complexities of collecting information on adverse events
(AEs) and serious adverse events (SAEs) frequently
aggregated by researchers during clinical trials.
Bioethicists are already uncertain about the quantity and type
of AE and SAE information to solicit from participants
during psychotherapy intervention trials
(Czaja et al.
, and this question is even more complex within the
context of a clinical trial of an online psychosocial
intervention like MoodSwings 2.0. If AE and SAE data are
systematically collected during patient assessments, can any
be reliably attributed to passive interactions with online
psychoeducational materials or discussion board posts,
especially when levels of involvement with the
website vary significantly from participant to participant? If
a study interview reveals an AE or SAE that represents
an ongoing, real-time crisis unrelated to bipolar
disorder, what is the corresponding ethical responsibility of
the interviewer? Should this information generate a Red
Flag? From one perspective, it seems unethical to request
and record information from participants about
sensitive life events without any intent of clinical follow-up or
planned utilization of the data. From another, it seems
unethical not to probe.
From an ethical standpoint, it is also important to
consider that internet interventions for mental health may
not always prove helpful for their consumers. A recent
analysis of negative effects from a pooled sample of
participants in four separate internet-based cognitive
behavioral therapy interventions for anxiety or depression
found that 9.3% of participants reported at least one
potentially treatment-related adverse event
et al. 2015)
. Subsequent qualitative content analysis
suggested that gaining knowledge and awareness may have
led to feeling anxious or depressed during treatment for
some, while others indicated frustration and dysphoria
related to persistent struggles implementing the content
on the available internet platform. Even more salient are
the recently published results from the MONARCA I
trial, which focused on daily, electronic, self-monitoring
in bipolar disorder using a randomized,
(Faurholt-Jepsen et al. 2015)
for participants receiving the intervention, depression
scores were higher when compared with those of
participants receiving a control condition. The authors suggest
that the act of daily monitoring of symptoms of
depression may have helped prolong them by continually
drawing awareness and possibly increasing rumination
and Parker 2009)
One unanticipated challenge encountered during the
MoodSwings 2.0 trial involved managing the
expectations of different entities including website
developers, clinical researchers, and research participants from
around the world, as these were sometimes at odds.
Similarly, website developers functioning within a
forprofit environment may not be sensitive to budget and
personnel constraints faced by smaller-scale sites like
MoodSwings 2.0 funded by not-for-profit sources.
MoodSwings 2.0 participants are by definition
individuals who actively engage in online activities. Such
consumers of the internet often have expectations for the
real-time availability and functionality of chosen
websites. Participants may have more interactive
familiarity with websites such as Facebook, Pinterest, or Twitter
which have capital and scope to provide technologically
sophisticated online experiences. A user expects to be
able to access his Facebook news feed or Pinterest board
on demand. Expectations for these websites are focused
on their ability to provide immediate and uninterrupted
entertainment. Further, a majority of internet
consumers seek some kind of health information on the
(Fox and Jones 2009)
, and their expectations are for
sound information that they can use to inform health
Individuals enrolled in an online program that provides
treatment for mental illness, like MoodSwings 2.0 for
bipolar disorder, likely possess slightly modified
expectations for their virtual experience. An individual visiting
a website like http://www.moodswings.net.au is likely in
search of more than simple entertainment. It seems
logical that participants have an ethical right to expect access
to discriminating psychoeducation on bipolar disorder
informed by the scientific evidence base as well as access
to moderated and safe peer discussion forums.
In turn, the clinical research staff has the right to
expect participants to safely and responsibly use the
MoodSwings 2.0 program, which is designed to be an
adjunct to in vivo clinical care. The ethical “catch” is
that the research team has no way to globally enforce or
verify that participants are seeking care on a local level.
And sometimes an unexpected escalation of mood or
psychotic symptoms during a bipolar episode may make
it very difficult for a participant to physically reach out
to a medical doctor or psychotherapist for immediate
help. In some cases, participants instead opted to post
to a MoodSwings 2.0 Discussion Board or send emails to
research staff via the internal messaging system. Within
the context of the trial, these instances generated Red
Flags, and participants were contacted within days. It is
vital that participants are informed and reminded about
the limitations of entirely self-help online interventions
and the link with their treating clinician is reinforced.
Future online interventions need to be cognizant of
moderating participant expectations and developing clear
protocols to address patient distress.
One commentary suggests that the “speed at which the
internet can spawn new ethical dilemmas has thus far
understandably outpaced the rate at which organized
psychology can develop ethical principles in a careful,
(Humphreys et al. 2000)
development of the MoodSwings 2.0 program and its
accompanying trial has represented a collision of many different
“worlds,” including proprietary software development
companies, academics from the United States and
Australia, clinical researchers accustomed to studies that
enroll human subjects in-person, ethics committees with
norms developed around face-to-face studies, and
participants with serious mental illnesses from around the
globe. In order for online interventions for mental health
to succeed as either clinical trials or reputable clinical
resources, risks and expectations of all involved need to
be carefully considered with a focus on ethical integrity.
VC was responsible for conception and design as well as initial drafting of the
manuscript. All other authors (EG, LB, DG, SL, SD, MB, and TS) were responsible
for revising the manuscript critically for important intellectual content of the
version of the manuscript to be published. All authors read and approved the
5 School of Population Health, University of Melbourne, Parkville, Australia.
6 School of Health Sciences and Psychology, Faculty of Health, Federation
University Australia, Ballarat, Australia. 7 University Hospital Geelong, Barwon
Health, Geelong, Australia. 8 Orygen, the National Centre of Excellence
in Youth Mental Health, Melbourne, Australia. 9 Florey Institute for
Neuroscience and Mental Health, Melbourne, Australia.
VC has received royalties from Up-to-Date and research funding from
NIH, the Stanley Medical Foundation, the Klingenstein Third Generation
Foundation, and the Spectrum Child Health Research Institute. EG was
supported by a Ph.D. scholarship from the Ian Parker Bipolar Research Fund
and Australian Rotary Health. LB has nothing to declare. DG has nothing
to declare. SL has received grants from Beyond Blue and travel assistance
from Sanofi-Aventis. SD has received grants and/or research support from
Stanley Medical Research Foundation, Foundation FondaMental, Eli Lilly,
GlaxoSmithKline, Organon, Mayne Pharma, and Servier. He has received
speaker’s fees from Eli Lilly, advisory board fees from Eli Lilly and Novartis
and conference travel support from Servier. MB has received grant support
from Stanley Medical Research Foundation, NIH, MBF, NHMRC, NHMRC
Senior Principal Research Fellowship, Cooperative Research Centre, Simons
Autism Foundation, Cancer Council of Victoria, MBF, Rotary Health, Meat
and Livestock Board, Woolworths, BeyondBlue, Geelong Medical Research
Foundation, Bristol Myers Squibb, Eli Lilly, Glaxo SmithKline, Organon,
Novartis, Mayne Pharma, and Servier. MB has received speaker support from
Astra Zeneca, Bristol Myers Squibb, Eli Lilly, Glaxo Smithkline, Lundbeck,
Pfizer, Sanofi Synthelabo, Servier, Solvay, and Wyeth as well as consultancy
from AstraZeneca, Bristol Myers Squibb, Eli Lilly, Bioadvantex, Merck, Glaxo
SmithKline, Lndbeck, Janssen Cilag, and Servier. MB is a co-inventor of two
provisional patents regarding the use of NAC and related compounds for
psychiatric indications, which, while assigned to the Mental Health Research
Institute, could lead to personal remuneration upon a commercialization
event. TS has received grants from NIH, VA Cooperative Studies Program,
Sunovion Pharmaceuticals, Inc., Elan Phama, Pathway Genomics, and Stanley
Medical Foundation as well as honoraria for consultancy from Astra Zeneca,
Merck, and A.H. Lundbeck. TS has also received royalties from Jones and
Bartlett and Up-to-Date.
Preparation of this manuscript was supported by the National Institute of
Mental Health Grants R34MH091284 and R34MH091384.
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
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