1

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

Acknowledgements

2

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.

Agenda

3

• Rationale for Digital Health• Overview of Modalities• IntelliCare Study• Future Directions

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.

5

Why Digital Health?

6

7

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

8

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

Digital Health Modalities

9

• 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.

Digital Health Modalities

10

• 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.

11

Modalities

12

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)

Telehealth

13

1959 University of Nebraska Medical Center:• Two-Way Television• Group Therapy

– Omaha VA– Lincoln VA– Grand Island VA

Hospital

14

Image from Wittson, Cecil L.; Affleck, D. Craig; Johnson, Van Mental Hospitals, Vol 12(10), 1961, 22-23.

Telehealth

15

• Equivalent clinical outcomes across conditions and populations

• Virtually equivalent process outcomes

• Cost effective

• Broad applications in addition to traditional 1:1 patient care

Telehealth

16

Telehealth

• 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

17

Computerized CBT

* For those who complete the interventions

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/

19

Computerized CBT

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

Videos of experts discussing insomnia and CBT-i provide authoritative and factual source of information.

www.VeteranTraining.va.gov 21

Computerized CBT

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

Computerized CBTGames and interactive exercises increase curiosity and

engagement.

www.VeteranTraining.va.gov 24

Computerized CBT

www.VeteranTraining.va.gov 25

Computerized CBT

26

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

27

Computerized CBT

28

Computerized CBT

1

mHealth

• 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

IntelliCarea modular, extensible digital platform supporting mental health and wellness

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.

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

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

5

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

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

Trial 2Randomized Trial Evaluating Coaching & Recommender

5

6

7

8

9

10

11

12

13

14

15

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

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

9

IntelliCare at UAMS

10

• 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

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

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

Coaching Dashboard

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

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:

mobileapps@uams.eduFor 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

Email Outreach

.

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.

17

Welcome Packet

Results

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

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

Primary Outcomes

Primary Outcomes

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+

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”

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

Commercialization

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

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.

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

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

Questions?

33

CJGreene@UAMS.edu

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?