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Digital Health Interventions for Depression and Anxiety
Carolyn J. Greene, PhDAssociate Professor, Department of
Psychiatry
Director of Team Science, Translational Research
InstituteAssociate Director, KL2 Mentored Research Scholar
Program
University of Arkansas for Medical Sciences
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Acknowledgements
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This work was supported by:
• National Institutes of Health (R44 MH114725 and K01 DK116925)
as well as by the Translational Research Institute (U54 TR001629)
through the National Center for Advancing Translational Sciences of
the National Institutes of Health.
• United States Department of Veterans Affairs, Office of Mental
Health & Suicide Prevention
• Actualize Therapy, LLC
The opinions expressed herein are my own and do not necessarily
reflect those of these organizations.
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Agenda
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• Rationale for Digital Health• Overview of Modalities•
IntelliCare Study• Future Directions
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Learning Objectives
1.Recognize the rationale for development of digital mental
health interventions.
2.Assess the benefits and challenges of specific digital health
modalities.
3.Describe key barriers and considerations related to successful
implementation of digital tools.
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Why Digital Health?
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RationaleIndividuals in need of mental health services may face
personal barriers including:
• Ambivalence• Cultural value of self-reliance • Desire for
privacy• Stigma• Physical mobility• Intermittent symptoms•
Time/schedule constraints• Cost
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They may also face system-level barriers including:
• Opaque processes• Insurance limitations• Insufficient
specialty care• Provider shortages in rural areas• Limited business
hours• Undesirable locations• Inconsistent quality of care
Rationale
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Digital Health Modalities
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• Technology has the potential to change the landscape of how we
deliver health services.
• Need for flexible models of care delivery that meet patients
where they are physically and psychologically (Hoge, 2011; Kazdin,
2011).
• Need to find a way to incorporate treatment gains and skills
into everyday practices.
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Digital Health Modalities
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• However, successful implementation of digital health
interventions is universally challenging.
• Implementing these services into practice requires considering
the natural flow of both patient care and informatics.
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Modalities
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DefinitionThe broad scope of digital health includes… mobile
health (mHealth), health information technology (IT), wearable
devices, telehealth and telemedicine, and personalized
medicine.
…digital technology has been driving a revolution in health
care. Digital health tools have the vast potential to improve our
ability to accurately diagnose and treat disease and to enhance the
delivery of health care for the individual.
…These technologies span a wide range of uses, from applications
in general wellness to applications as a medical device. …
(Food & Drug Association, 2020)
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Telehealth
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1959 University of Nebraska Medical Center:• Two-Way Television•
Group Therapy
– Omaha VA– Lincoln VA– Grand Island VA
Hospital
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Image from Wittson, Cecil L.; Affleck, D. Craig; Johnson, Van
Mental Hospitals, Vol 12(10), 1961, 22-23.
Telehealth
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• Equivalent clinical outcomes across conditions and
populations
• Virtually equivalent process outcomes
• Cost effective
• Broad applications in addition to traditional 1:1 patient
care
Telehealth
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Telehealth
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• Computerized CBT (cCBT) is proven to be as effective as
face-to-face CBT*
• cCBT is the “first line” treatment for depression in the UK
and Australia
• Interactive, engaging cCBT programs are often marketed as
“courses” to avoid the stigma of therapy
• Variability in role of provider
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Computerized CBT
* For those who complete the interventions
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Computerized CBTwww.VeteranTraining.va.gov offers free online
courses that teach skills and tools to help users enhance different
aspects of their lives.
They can go to any course at the time and place of their
choosing. Users can remain anonymous.
To get started, just go to the homepage and press “Start the
Course”.
www.VeteranTraining.va.gov18
http://www.veterantraining.va.gov/
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Computerized CBT
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Path To Better Sleep • Contains all components of
CBT-I• Completely self-guided with
no clinician support needed• Free and anonymous• Text at 7th
grade reading
level• 508-compliant and TBI
friendly• Developed with
Veteran/military culture in mind
www.VeteranTraining.va.gov 20
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Videos of experts discussing insomnia and CBT-i provide
authoritative and factual source of information.
www.VeteranTraining.va.gov 21
Computerized CBT
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www.VeteranTraining.va.gov 22
Videos of real Veterans sharing authentic stories helps increase
motivation and credibility.
“I would tell a person to get over the hump with the sleep
prescription… just stick with it, it will definitely help you.”
Computerized CBT
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Computerized CBTGames and interactive exercises increase
curiosity and
engagement.
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www.VeteranTraining.va.gov 24
Computerized CBT
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www.VeteranTraining.va.gov 25
Computerized CBT
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An interactive eight question quiz will help Veterans begin to
understand their sleep issues. Insomnia, sleep apnea and narcolepsy
are just a few of the possibilities.
Computerized CBT
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Computerized CBT
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Computerized CBT
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mHealth
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• Up to 325,000 health and wellness apps• Over 10,000 are
specifically behavioral health
applications• The most popular behavioral health apps offer
relaxation, meditation or mindfulness (not actual CBT)
• Most people stop using apps within 2 weeks of download
• Few publicly available apps have been evaluated in controlled
trials
• Many apps that have been evaluated are not publicly
available
mHealth
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IntelliCarea modular, extensible digital platform supporting
mental health and wellness
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100’sof randomized clinical trials show:
but real world implementation in healthcare has failedLow
patient engagementDoes not fit into care managers’ workflows
Digital interventions supported by coaches are as effective as
psychopharmacology and psychotherapy.
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IntelliCare Public Deployment Use
Lattie… Mohr, Internet Interventions, 2016; 4: 152-8.Helander et
al. J Med Internet Res. 2014;16:e109
Adoption at Time of Trial
120,000+ Installs10,000+ Active Users
Patient Engagement
4.7 – 35.7 %of all downloads using app more than 10 times.(vs
external mobile health benchmark: 2.6%)
Average Use13.2 session over 35 daysBest App Average27 sessions
over 46 days
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Trial 18-Week Coached Trial
14%
22%
45%
40%
42%
37%
0% 10% 20% 30% 40% 50%
Anxiety
Depression
Diagnostic Status at End of Treatment
Full Remission Recovery Symptomatic
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6
7
8
9
10
11
12
13
14
Baseline Week 4 Week 8
Change in Symptom Severity
PHQ-9 GAD-7
Mohr DC, Noth Tomasino K, Lattie EG, Palac HL, Kwasny MJ,
Weingardt K, Karr CJ, Kaiser SM, Rossom RC, Bardsley LR, Caccamo L,
Stiles-Shields C, Schueller SMIntelliCare: An Eclectic,
Skills-Based App Suite for the Treatment of Depression and Anxiety
J Med Internet Res 2017;19(1):e10
99 participants with PHQ-9 ≥ 10 or GAD-7 ≥ 8Patients from Health
Partners/Online
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Trial 1
User Engagement Over Time
2123
2527
2829
26 26
0
5
10
15
20
25
30
35
1 2 3 4 5 6 7 8Week
Average App Launches per Week
195Average app launches over 8 weeks
17 sec.Median time per session(Average = 1.1 min)
30-40 min call~3 SMS/week
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Trial 2Randomized Trial Evaluating Coaching &
Recommender
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6
7
8
9
10
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12
13
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Baseline Week 4 Week 8 (EOT) 3 M. F/Up 6 M F/Up
Coach/RecCoach/No RecSelf-Guided/RecSelf-Guided-No Rec
PHQ
-9 PHQ-9 (Depression)• Coached vs. Self-Guided: p=.05•
Recommendations: p=.03GAD-7 (Anxiety)• Coached vs. Self-Guided:
p=.04• Recommendations: p=.60Average app use: 218 times
302 participantswith Depression or Anxiety
Significant reductions in PHQ-9 & GAD-7 (ps
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IntelliCare at UAMS• NIH funded an SBIR grant for a hybrid
effectiveness-
implementation trial to study use of IntelliCare with coaching
support among primary care patients at UAMS. (#R44MH114725)
– Goal of recruiting 128 patients with mild to moderate
depression.
– Used PHQ-9 score to align with UAMS process– Pragmatic
inclusion/exclusion criteria – Used a wait-list control– Aims
included optimizing the apps and designing
commercialization plan– All study procedures were conducted
virtually
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IntelliCare at UAMS
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• Northwestern University • Actualize Therapy LLC• UAMS
• Thomas Powell, MD in Department of Biomedical Informatics•
Faculty throughout Department of Internal Medicine• Center for
Health Literacy• Translational Research Institute• Center for
Health Services Research:
• Michael Cucciare, PhD• Amanda Lunsford• Casey Orr• Chris
Peralta• Jay Withers
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My Mantra helps you develop and use simple phrases and images
that can help you to notice and remember positive things in your
daily life. Using My Mantra can help you feel good, remind you of
your strengths and find meaning in the daily grind.
My Mantra
Day to DayDaily Feats
Day to Day focuses on a different skill each week for five
weeks. You’ll receive daily messages to help you apply each skill
consistently for a week of your life.
Daily Feats helps you stay engaged in life and celebrate your
accomplishments –both big and small. Over time, you’ll find it
easier to do things, your motivation will increase, and your mood
will improve.
Worry Knot teaches you to manage your worry and reduce your
anxiety using a proven worry management technique. It provides a
guided tool to address specific problems that you can’t stop
thinking about.
Worry Knot
Thought Challenger helps you control how you feel by challenging
negative thoughts. It helps you improve your mood, decrease
anxiety, and feel better by teaching you to recognize and change
unhelpful thinking.
Thought Challenger
IntelliCare HubThe IntelliCare Hub helps you manage the other
apps. It provides notifications, psycho-ed materials, and
administers assessments.
IntelliCare Mobile Apps Overview
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Noth KN, Bardsley LR, Lattie EG, Mohr DC. DigitalHub -
Northwestern University. 2018. IntelliCare Study Coaching Manual
URL:
https://digitalhub.northwestern.edu/files/00fa4294-5b9f-4afc-897a-7fffceae8f3fMohr
DC, Cuijpers P, Lehman K. Supportive accountability: a model for
providing human support to enhance adherence to eHealth
interventions. J Med Internet Res 2011 Mar 10;13(1):e30
• Based on a supportive accountability model• Bachelor’s level
trained coaches supervised by a licensed psychologist• Monitors
weekly assessments and daily app engagement• Coach provides a 30-45
minute welcome call to:
• Ensure the apps are downloaded• Orient participant to program
and set expectations• Help participant establish personal goals•
Recommend an initial app
• Potential mid-point call if needed• All other communication
(~2-3 times/week) is by text
• Positive reinforcement for engaging in apps• Trouble shoot
technical difficulties• Gentle reminders to use apps• Finding out
what works for them• Recommendations for next app to try
Coaching
https://digitalhub.northwestern.edu/files/00fa4294-5b9f-4afc-897a-7fffceae8f3f
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Coaching Dashboard
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Recruitment Methods• Traditional (i.e. flyers around campus,
handouts in clinics,
presentations to clinical teams)• EHR based referrals• Emails
with link to recruitment website• Social media• Newsletters and
free media
* All materials edited by UAMS Center for Health Literacy
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Intellicare Apps
We are looking to enroll people who are:
UAMS Primary Care patients.
Currently experiencing symptoms of depression or anxiety.
iPhone or Android smartphone users.
At least 18 years old.
Contact the study team at:
[email protected] more information visit:
www.JoinIntelliCare.comSite Principal InvestigatorCarolyn J
Greene, PhD
Implementing an Innovative Suite of Mobile Applications for
Depression and Anxiety
A UAMS Research Study testing the use of IntelliCare + Coaching
in Primary Care
What is IntelliCare?
IntelliCare is a group of mobile applications (apps) created to
aid people with depression and anxiety using evidence-based
Cognitive Behavioral Therapy (CBT) Tools.
In a recently published field trial of IntelliCare, participants
showed substantial reductions in both depression and anxiety (p
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Email Outreach
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IntelliCare at UAMS• We created an order in EPIC that was
available in all Outpatient
Internal Medicine Clinics.• In clinics that use PHQ-9 to screen,
if a patient has a PHQ-9
score > 9, the BPA will fire.
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Welcome Packet
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Results
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Consort Flow Diagram 435 Individuals initiated a web
screen to assess eligibility
280 Individuals assessed for eligibility via chart review
207 Patients initiated a baseline assessment
146 Randomized
155 Excluded 108 Did not meet inclusion criteria
2 Under 18 years old 12 Did not have an Android or iOS
smartphone 94 Did not have at least moderate symptoms of
depression or anxiety 47 Did not consent to study
73 Excluded 50 Not a patient at UAMS 1 Visual, motor, or hearing
impairment 19 Other diagnoses inappropriate for the trial 3 Engaged
in other forms of psychotherapy
74 Randomized to Intervention Arm 55 (74%) elevated depression
and anxiety
at screening 9 (12%) elevated depression at screening 10 (14%)
elevated anxiety at screening
67 (91%) Received intervention per protocol 7 (9%) Did not
receive intervention
1 Declined intervention 1 Withdrew from study 4 No response 1
Phone incompatible
72 Randomized to Waitlist Control Arm 52 (72%) elevated
depression and anxiety
at screening 6 (8%) elevated depression at screening 14 (19%)
elevated anxiety at screening
62 (86%) Received intervention per protocol 10 (14%) Did not
receive intervention
1 Withdrew from study 6 No response 2 Phone incompatible 1 Moved
out of State
72 (97%) Completed ≥1 follow up assessment
74 To be included in the primary outcome, intent-to-treat
analyses
72 To be included in the primary outcome, intent-to-treat
analyses
70 (97%) Completed ≥1 follow up assessment
61 Excluded 49 Did not meet inclusion criteria
1 Exceeded suicide risk criterion 1 Insufficient technology
access 23 Other diagnoses inappropriate for the trial 24 Engaged in
other forms of psychotherapy
12 Did not complete baseline
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Demographics
Min: 19
Avg: 42
Max: 83
0
10
20
30
40
50
60
70
80
90
Age
Female82%
Male18%
0%
20%
40%
60%
80%
100%
Sex
Below povert
y ($25K)22%
1x-2x poverty line
38%
2x-3x poverty line
26%
>3x poverty line14%
0%
20%
40%
60%
80%
100%
Income
White63%
African American
34%
Other/Mixed 3%
0%
20%
40%
60%
80%
100%
Race/Ethnicity
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Primary Outcomes
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Primary Outcomes
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Effectiveness by Severity & User Engagement
12.2
8.4
7.6
16.7
8.28
21.5
9.9
6.5
4
6
8
10
12
14
16
18
20
22
24
Baseline Week 4 Week 8
Depression Outcomes (PHQ-9)
Moderate (PHQ 10-14) Mod-Severe (PHQ 15-19) Severe 20+
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Qualitative Interviews
Patient Feedback Care Manager Feedback
Physician Feedback
“This program you have invented gives me tools to help myself… I
am happy and sleeping again. I do not have to reach for a drug to
calm down.”
“The apps have given me a quick tool that I can access in crisis
situations that helps me work through negative though patterns and
regain calm.”
“This program appears to be helping many of our participants
make a difference in how they live their lives and the way they
view it. What a wonderful thing to be able to be a part of!...
These experiences give me goosebumps and warm my heart."
“Patients can use (IntelliCare) on their own… some patients are
sensitive to share with someone directly… this is something
available to them all the time, which is great”
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Implementation• Unexpected delays implementing EPIC order•
Optimal integration into workflow may be idiosyncratic• Providers
were highly supportive, but yielded few participants• Digital
outreach was more successful• Many participants needed multiple
exposures to information prior to
enrolling
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Commercialization
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Digital Therapeutics• A medical intervention delivered via
software• Interventions must be evidence-based*• Reviewed or
certified by regulatory bodies to support claims of
efficacy• May require a prescription or medical referral•
Usually allows clinician to view patient data• Usually has a fee or
cost
* The threshold of “evidence” is highly debatable
Future Directions
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Pear Therapeutics PipelineSomryst delivers Cognitive behavioral
therapy for insomnia (CBTi) for treatment of chronic insomnia.
Provides a clinician dashboard showing sleep metrics and app
use.
reSET delivers CBT (for 90 days) as an adjunct to contingency
management system for patients enrolled in outpatient SUD
treatment. A dashboard displays patient use information and
self-reports. Also allows clinic to input data such as urine drug
test restults.
reset-O is specifically for Opioid Use Disorder Treatment and
provides an 84-day intervention.
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CBT + DeviceFreespira is indicated as an adjunctive treatment
for symptoms associated with panic disorder (PD) and/or
post-traumatic stress disorder (PTSD), to be used under the
direction of a healthcare professional, together with other
pharmacological and/or non-pharmacological interventions. After
receiving training by a clinician or Freespira coach, patients
complete an at-home 28-day protocol with two 17-minute breathing
sessions each day, for one month. Four weekly virtual coaching
sessions are also included. Digital Therapeutics Alliance
website
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Kaia is a mobile app for chronic back pain. The self-help
intervention is based on multimodal rehabilitation (MMR), an
integrative, evidence-based approach to pain. Daily training
sessions are delivered to users directly via Kaia on their device.
Users also interact with their Kaia Coach and/or care managers
through the app. A prescription is not required. Healthcare
providers may access the Kaia dashboard to monitor patient usage
and clinical outcomes. Digital Therapeutics Alliance website
CBT + Device
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Questions?
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[email protected]
Greene GR Part 1 revisedSlide Number 1AcknowledgementsAgenda
Learning ObjectivesSlide Number 5Slide Number 6Slide Number 7
RationaleDigital Health ModalitiesDigital Health ModalitiesSlide
Number 11Slide Number
12TelehealthTelehealthTelehealthTelehealthSlide Number
17Computerized CBTComputerized CBTPath To Better Sleep Computerized
CBTComputerized CBTComputerized CBTComputerized CBTComputerized
CBTComputerized CBTComputerized CBTComputerized CBT
Greene GR Part 2 revisedSlide Number 1Slide Number 2Slide Number
3Slide Number 4IntelliCare Public Deployment Use�Trial 1�8-Week
Coached Trial�Trial 1�User Engagement Over TimeTrial 2�Randomized
Trial Evaluating Coaching & Recommender �IntelliCare at
UAMSIntelliCare at UAMSSlide Number 11CoachingCoaching
DashboardRecruitment MethodsSlide Number 15Slide Number
16IntelliCare at UAMSSlide Number 18Slide Number 19ResultsSlide
Number 21Demographics�Primary Outcomes �Primary Outcomes
�Effectiveness by Severity & User EngagementQualitative
InterviewsImplementationCommercialization Slide Number 29Pear
Therapeutics PipelineCBT + DeviceSlide Number 32Questions?