Technology holds enormous potential to help improve access and outcomes for mental health services. Digital health resources can help suffers, carers and advocates through easier access to education, training, support, and intervention. This workshop presented at the 2015 National Alliance for Mental Illness Annual Convention critically examines current and emerging digital mental health products and services in terms of their purpose, efficacy, and utilization potential. Critical ethical, legal, and insurance issues are discussed and with an emphasis on developing best practice.

1. Science
vs. Snake Oil
Evidence-based mental
health technology
Megan Jones
@golantern
golantern.com
@jmegjones

2. Hi.

3. Who am I?
A lucky, privileged person who experienced mental illness and recovered.
A family member and friend of individuals who live with mental illness.
A concerned and engaged community member.
A committed advocate, researcher, therapist.

4. Conflict of Interest Statement
I, Megan Jones, PsyD, am an employee and shareholder of
Lantern (Thrive Network, Inc.). Lantern is an online program
designed to help individuals improve emotional wellbeing.
My bias.

5. A word about therapy.
Therapy is critically important and essential.
It helped me save my life.

6. 450M
Adults suffer from a
mental disorder each year worldwide
- World Health Organization

7. 1 in 10 people get the therapeutic help they need

8. 1. STIGMA
2. ACCESS
3. COST
Barriers to Mental Health Care

9. 1. STIGMA
2. ACCESS
3. COST
4. Effectiveness
Barriers to Mental Health Care

10. U.S. adult population
Distress Level
Self-Help
Moderate Stress & Anxiety:
Not Targeted Today
Therapy
Pharma
Today’s Mental Health Market
Source: Marketdata “Overview of U.S. Self-Improvement Market”; IMS Health, “Medicine Use and Shifting Costs of Healthcare: A Review of the Use of
Medicines in the United States in 2013”; SAMSHA; Note: Therapy data includes SAMSHA-reported mental health spend to physicians, other
professionals (e.g., social workers), and specialty mental health organizations, and excludes hospital and specialty in-patient hospital spend

11. The need to reboot.
Innovation is needed to fill the gap between
self-help and therapy.

12. How Can Technology Help?
85% mobile access
There are endless
possibilities when it comes
to marrying mobile and
healthcare.

14. Integrating technology & therapy could…
• Enable better performance assessment through timely access
to precise data
• Inform and facilitate targeted policy and initiatives (understand
and document the practical needs and evidence)
• Optimize expenditures to reduce redundancy, promote self-
management and ensure “right help at the right time”
Source: Young and Well Cooperative Research Center (October 2014). Innovative technologies in e-mental health: Briefing
paper for the National Mental Health Commission.

15. Beyond a complement to face-to-face therapy
• Reduce complexity
• Remove inefficiency
• Promote accountability and measure effectiveness
• Provide consumer choice
• Reduce disparities in access to care
Source: Young and Well Cooperative Research Center (October 2014). Innovative technologies in e-mental health: Briefing
paper for the National Mental Health Commission.

16. Pivot toward user-centered system
• User-centered design places the individual at the center of a
system of care
• Technology that is “one size fits all” does not resolve key
issues of real-world efficacy and disparity in access
• Opportunity: allow users to control their data, peer- and family-
support, enhanced self-management, customizable treatment
pathways

17. Evidence for behavioral health
technology

18. Online interventions
• Evidence for online prevention, self-help, treatment for wide
range of mental health problems
• Effect sizes comparable to face-to-face treatment (med-large)
• Evidence-based programs for depression, anxiety, substance
use, eating disorders, adjustment disorders, resilience

19. • Increasingly lower barrier to development and market intro
• Very few high-caliber studies, early days of evidence-base
• Clear guidelines are needed for development and reporting
Self-management apps & resources

20. Opportunities
• Self-monitoring is key to many evidence-based therapies and
well facilitated by technology
• Many evidence-based treatments are amenable to digital
delivery: peer support, psychoeducation, talk therapy, CBT
• Meet people where they are - many individuals already use
social media and online tools to help manage conditions and
seek support
• Allow flexibility, self-management, choice

21. Categories of technology
• Self-monitoring or goal setting, no social or support features
• Information
• Social and support features (connect and share)
• Connected to larger healthcare or support ecosystem

22. Technology Use Case
Examples

23. www.nationaleatingdisorders.org
Screening
• Empowering and quick
way to receive feedback
• Should not provide
diagnosis

24. Assessment
• Validated measures
• Adaptive design to reduce
response burden
• Feedback designed to educate
and empower user
• Link to appropriate level of care
and resource

25. Medication Monitoring
• Medication scheduling
• Alerts for interactions
• Information about side effects
• Game-like incentives to
establish and reach goals

26. Leveraging Data
• Patient-powered online
community
• Linked to research that helps
generate actionable, real-world
data about the nature of disease

27. Reminders
• Just-in-time in vivo interventions
• Ecological momentary assessment
• Psychoeducational reminders
• Scheduled reminders

28. Personalized self-management
1:1 Coaching Daily Sessions Relaxation Techniques

29. Tele-mental health
• HIPAA-compliant
platforms linking licensed
providers with clients in
their states
• Research supports
efficacy of treatments
delivered via
videoconference

30. Social, Sharing, Support
• Peer-to-peer
support
• Real-time access to
supportive
community
• Empowering

31. Crisis Intervention
• Easy, quick access
to crisis support
• User-centered
product design

32. Training & Education
! Online, adaptive learning
! Webinars and eTraining
institutes for psychotherapy
and telemental health
! Training non-professionals to
deliver help & support

33. Progress has been made.
Key challenges remain.

34. Challenges - Research
• Research funding has been piecemeal and lacking
coordinated vision and strategy.
• This leads to unacceptable levels of redundancy and
uncoordinated development, duplication and waste.
• Dissemination of narrowly focused products does not extend
evidence-base nor allow interoperability to improve overall
system and coordination of care.

35. Challenges - Risks and side effects
• Need to understand and meet the needs of a vulnerable
population
• Consider implications of reliance on the technology and
potential for user abandonment
• Potential for symptom severity increase or development of
new symptoms for which technology is not suitable

36. Stigma
• Potential that technology is only source of help/support.
• How is privacy maintained?
• How does the product/service marketing impact stigma?
• Does the product empower users?

37. Equality of access
• Digital divide is shrinking but still exists
• Some individuals may not be able to afford even low-cost
technology-based services
• Few behavioral health technologies are reimbursable by
insurance

38. Challenges - Piggybacking vs. novelty
• Competitive environment fuels differentiation based on
branding rather than novelty and true difference
• Nice branding and design can disguise absence of credibility
and evidence-base

39. “Disruption” is great, but where
do we draw the line?

40. Lack of Evidence
• “Many health apps are based on flimsy
science at best, and they often do not
work” - By Rochelle Sharpe, New England Center for Investigative Reporting,
Washington Post, November 12, 2012
• “FDA regulation can’t keep pace with
new mobile health apps”- By Joshua Barajas, PBS.org, July
7, 2014

41. The need for
ETHICS & EVALUATION
in behavioral health technology

42. Key questions
• Which behavioral health technologies should organizations
recommend or endorse?
• How should technologies be evaluated?
• How should concerns over safety, privacy, and effectiveness
be addressed?
• What evidence is required? How to differentiate effective or
evidence-based technology from thousands of options?

43. The goal should be:
• Flexible and helpful standards and evaluation framework
• Articulation of industry best practices
• Raise standards to improve market “pull” for technologies that
are evidence-based, address safety, privacy, and security, and
user-centered
• Increase adoption of effective technology in practice

44. Evaluation & use case match
• Behavioral health technologies vary in aims:
• Clinical benefit
• Tool
• Need to spend research time and funding wisely
• Not all technologies need to be held to the same standard

45. Factors that always apply
• Safety
• Privacy
• Security
• Ethics and legality
• Truth in advertising

46. Evaluation & regulatory
frameworks

47. 1. Safety, security privacy: What data is collected, ownership,
what is done with it?
2. Source: Who developed it, who profits, who was involved?
3. Access: How to get it, cost, devices needed?
4. Relevance, content, accuracy: Need or priority addressed?
Based on good practice or change theory?
5. Impact: Who benefits? Measurement?
Adapted from the National Institute for Health Research (NHS) MindTech Healthcare Technology
Key questions

48. Product - user fit
• Which symptoms is the technology appropriate for?
• What level and range of symptom severity is a fit?
• Which users?
• For whom is the technology not a fit?

49. • User value: Traction (audience base, user acquisition,
retention, LTV); Meaningful engagement with product
• Intended value: Is product achieving intended purpose and
demonstrating place in mental health system
• Social value: Effectiveness (mental wellbeing outcomes)
Product - value

50. FDA: Mobile Medical App
• Used as an accessory to a regulated medical device; or
• To transform a mobile platform into a regulated medical device
• Intended use is for diagnosis of disease, mitigation, treatment
or prevention of disease it is a medical device.

51. FDA: Regulated Mobile Medical App
• Mobile apps that extend other medical devices through patient
monitoring or analyzing medical device data (e.g., app that
controls delivery of insulin)
• Transform mobile platform into medical device (e.g., blood
glucose strip reader)
• Patient-specific analysis, diagnosis, or treatment
recommendations

52. FDA: Apps - Enforcement Discretion
• Provide supplemental clinical care by coaching or prompting,
to help patients manage care in daily environment (e.g., apps
that coach patients with adherence to medication)
• Provide simple tools to organize and track information (e.g.,
patients with anorexia to track eating behavior)
• Provide easy access to information (e.g., use diagnosis to
provide clinician with best practice treatment guidelines or
look-up drug interactions)

53. Examples:
• Help patients document, show, and communicate to providers
(e.g., videoconferencing tools to enhance communication)
• Perform simple calculations routinely used in clinical practice
(e.g., Body mass index)
• Enable individuals to interact with health records systems
• Help patients with diagnosed psychiatric conditions (e.g.,
depression) maintain behavioral coping skills by providing
behavioral technique or audio messaging
• Motivational guidance to patients recovering from addiction
• Use behavioral risk factors to provide personalized screening,
counseling, or preventative recommendations

54. Intended use (FDA definition)
• Shown by labeling claims, advertising materials, or oral or
written statements by manufacturers or their representative.
• When intended use of mobile app is for diagnosis of disease
or other conditions, or the cure, mitigation, treatment or
prevention of a disease, or is intended to affect the structure
or any function of the body of man, the mobile app is a device.

55. Ethics - truth in advertising
American Psychological Association Ethics Code: “Psychologists
do not make false, deceptive or fraudulent statements concerning
(1) their training, experience or competence; (2) their academic
degrees; (3) their credentials; (4) their institutional or association
affiliations; (5) their services; (6) the scientific or clinical basis for
or results or degree of success of, their services; (7) their fees; or
(8) their publications or research findings.”

56. Contextualizing the product/service
• APA Ethics Code: 8.11 Plagiarism
• “Psychologists do not present portions of another's work or
data as their own, even if the other work or data source is
cited occasionally.”
• What does this mean for how you describe the research-base
of a product?

57. Presenting outcomes and research
• How does the cited research relate to the actual product?
• How is data represented? Is a sample size provided?
• Controlled vs. uncontrolled comparisons
• Consent of participants/users? Human subjects approval (if
presented/published)

58. Problems:
Scale is misleading
(better if: 50% or 100%)
No sample size (better
if: N=##)
Clients implies potential
treatment relationship
(better if: “user” or
“participant”)

59. Problem:
Critics have raised concern
about recommending text-
only “therapy” as a
treatment without evidence.
No mention of actual
studies or links to abstracts.
How does this impact
stigma and informed
consent?

60. Accuracy in endorsements
• Is there reciprocity in endorsements across organizations?
• Are the endorsements from an institution or individual without
conflict of interest?
• Are endorsements from an organization that has a thorough
and appropriate review process for behavioral health tech?

61. Technology in clinical practice
Practitioners who integrate technology into practice or deliver therapeutic
services via technology should adhere to minimum standards and practices
to work in an ethical manner

62. • Encryption of records and communication
• Backup systems for records
• Complete password protection for hardware, files, software,
etc. and use firewalls
• Protect computers and data on computers via virus protection
• Knowledge of hardware and software
• Trust and careful selection of third-party services
Basics of using technology in practice
Source: Anthony, K. & Nagel, D.M. (2009). Therapy online: A practical guide. Sage Publishing: London.

63. Scope of practice guidelines
• Indicates the specific area of practice
• May include geographic location of practice, ability to practice
across geographical boundaries and the parameters of
practice
• Boundaries and limitations of discipline (e.g., psychological
diagnosis and provision of treatment)
• Laws and ethics of discipline and geographic region
Source: Anthony, K. & Nagel, D.M. (2009). Therapy online: A practical guide. Sage Publishing: London.

64. Training, knowledge, supervision
• Core to “best practice”
• Formal and informal training, current literature
• Clinical and peer supervision and/or consultation
Source: Anthony, K. & Nagel, D.M. (2009). Therapy online: A practical guide. Sage Publishing: London.

65. Key competency areas
• Online therapy
• Online clinical and peer supervision
• Text-based therapy
• Telehealth
• … and many many more!
Source: Anthony, K. & Nagel, D.M. (2009). Therapy online: A practical guide. Sage Publishing: London.

66. Guidelines for websites
• Crisis intervention information (e.g., Befrienders)
• Practitioner contact information
• Practitioner education, license and certification information
• Terms of use and privacy policy
• Encrypted transmission of therapeutic and payment
information
Source: Anthony, K. & Nagel, D.M. (2009). Therapy online: A practical guide. Sage Publishing: London.

67. Informed consent in online therapy
• Advantages and disadvantages of online therapy
• Explanation of encryption and for what data it is used
• Therapist as owner of the record
• File storage procedures
• Privacy policy (Notice of Privacy Practices and HIPAA)
• Practitioner’s geographic jurisdiction
• What to do in context of technology interruption/breakdown
• Emergency contact
• Cultural and location specifics that may impact services
• Dual relationships
• Insurance and payment information
Source: Anthony, K. & Nagel, D.M. (2009). Therapy online: A practical guide. Sage Publishing: London.

68. Best practices for behavioral health tech?
• Best practices have been developed for face-to-face
treatments and services, but often not for technology-
facilitated care.
• How should existing best practices be applied to behavioral
health technology?

69. Conclusions
• Before it’s too late, digital health companies need to define their
responsibility and obligation to their users and their employees.
• While other technology companies can rally around mottos like
“fail fast, fail often” and say they're “disrupting” the market, in
healthcare, failing too often (or at all) can directly and seriously
impact a user’s life.
• And breaking the rules can cost some employees – like health
services providers – their careers.

70. Recommendations
• Create products that are for everyone, including the toughest
use cases
• Objectively measure outcomes (including side effects)
• Pro-actively apply best-practices and ethical/legal standards
• Follow scientific and clinical standards for informed consent,
privacy, and data representation and reporting

71. Science
vs. Snake Oil
Evidence-based mental
health technology
Megan Jones
@golantern
golantern.com
@jmegjones