SBIR-STTR Award

Improving adherence to evidence-based practice using an innovative and easy-to-use health IT solution
Award last edited on: 5/19/2023

Sponsored Program
STTR
Awarding Agency
NIH : NIMH
Total Award Amount
$837,485
Award Phase
2
Solicitation Topic Code
242
Principal Investigator
Brian E Bunnell

Company Information

Adhere.ly LLC

1415 William Road
Lutz, FL 33558
   (480) 688-1185
   brianebunnell@gmail.com
   www.adhere.ly

Research Institution

University of South Florida

Phase I

Contract Number: 1R41MH126734-01
Start Date: 7/1/2021    Completed: 5/31/2023
Phase I year
2021
Phase I Amount
$442,716
Homework, or between-session practice of skills learned during therapy, is one of the most integral, yet underutilized components of high-quality, evidence-based mental health treatments (EBTs) such as CognitiveBehavioral Therapy (CBT). Many providers struggle to consistently develop, assign, and assess homework exercises with their patients, and many patients have difficulty remembering to practice skills in a correct andtimely way that fosters adequate learning. Innovative health IT solutions are needed to overcome these barriers to implementing this crucial component of high quality EBTs. To meet this need, our experienced team at Adhere.ly, LLC, in partnership with the University of South Florida, the Medical University of South Carolina,and Doxy.me, LLC developed Adhere.ly, an innovative, state-of-the art, and user-friendly web-based solutionto improve provider implementation and patient engagement in homework during EBTs. Adhere.ly includesengaging therapeutic exercises for providers to introduce, practice, and assign as homework to patients, whoreceive SMS/email reminders with links to practice those exercises during the week. Adhere.ly was initiallydeveloped for providers treating children with PTSD and their caregivers. Broadening Adhere.ly's features andexercises will increase its clinical utility and ability to support NIMH priorities and PA-18-579 Specific Areas ofResearch Interest in "Tools and Platforms to Improve the Dissemination and Implementation of EBTs." Theobjectives of this Phase I STTR proposal-guided by the Accelerated Creation to Sustainment model andModified Consolidated Framework for Implementation Research-are threefold. First, we will seek tounderstand and prioritize key stakeholder goals, challenges, affordances, and constraints by conductingindividual, semi-structured qualitative interviews with adult mental health patients, providers, andadministrators (n≤20 each) and a quantitative survey of 100 providers. We will conduct a mixed methodsanalysis to inform the design of new Adhere.ly features and exercises and an implementation/sustainment (I/S)blueprint (Aim 1). Second, we will use participatory design methodologies (e.g., co-design workshops) withadult mental health patients and providers to iteratively design, refine, and develop new Adhere.ly features andtherapeutic exercises that support a range of adult EBTs, and an I/S blueprint (Aim 2). Third, we will conduct afeasibility Optimization, Effectiveness, and Implementation (OEI) Hybrid trial with 20 community mental healthproviders randomized to CBT+Adhere.ly (n=10) vs. CBT alone (n=10), and 40 treatment seeking,provider-referred adult patients with clinically elevated anxiety and/or depression (outcomes), which we willassess at baseline and 3-months post-baseline. We will assess homework use by providers and adherence ofpatients (targets) weekly via session audio recordings and patient-report. We will optimize new features,exercises, and our I/S plan during the trial and assess implementation outcomes post-implementation (Aim 3). PROJECT NARRATIVE Mental health disorders affect 1 in 5 adults in the U.S., yet there is a gap in the quality of mental health care these patients should receive vs. what they do receive. Homework, or between-session practice of skills learned during therapy, is an integral component of high quality, evidence-based mental health care, but its implementation in "real world" clinical settings is generally lacking. This project aims to expand and preliminarily evaluate an innovative, web-based solution to improve the implementation of this crucial component of evidence-based mental health care. Adult ; 21+ years old ; Adult Human ; adulthood ; Affect ; Anxiety ; Mental disorders ; Mental health disorders ; Psychiatric Disease ; Psychiatric Disorder ; mental illness ; psychiatric illness ; psychological disorder ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Cognitive Therapy ; Cognition Therapy ; Cognitive Psychotherapy ; cognitive behavior intervention ; cognitive behavior modification ; cognitive behavior therapy ; cognitive behavioral intervention ; cognitive behavioral modification ; cognitive behavioral therapy ; cognitive behavioral treatment ; Communities ; Mental Depression ; depression ; Electronic Mail ; E-Mail ; Email ; electronic communication ; Environment ; Exercise ; Florida ; Patient Care ; Patient Care Delivery ; Goals ; Health ; Health Personnel ; Health Care Providers ; Healthcare Providers ; Healthcare worker ; health care personnel ; health care worker ; health provider ; health workforce ; healthcare personnel ; medical personnel ; treatment provider ; Interview ; Learning ; Marketing ; Mental Health ; Mental Hygiene ; Psychological Health ; Mental Health Services ; Mental Hygiene Services ; Methods ; Methodology ; National Institute of Mental Health ; NIMH ; Online Systems ; On-Line Systems ; online computer ; web based ; Patients ; Research ; South Carolina ; Post-Traumatic Stress Disorders ; PTSD ; Post-Traumatic Neuroses ; Posttraumatic Neuroses ; Posttraumatic Stress Disorders ; post-trauma stress disorder ; posttrauma stress disorder ; traumatic neurosis ; Surveys ; Survey Instrument ; Time ; Universities ; Caregivers ; Care Givers ; Administrator ; Healthcare ; health care ; Youth ; Youth 10-21 ; base ; improved ; Area ; Clinical ; Phase ; Medical ; Link ; grasp ; Grips ; Individual ; Educational workshop ; Workshop ; Fostering ; Therapeutic ; tool ; interest ; experience ; success ; Structure ; skills ; Reporting ; Position ; Positioning Attribute ; Modeling ; theories ; Intervention Strategies ; interventional strategy ; Intervention ; Provider ; Effectiveness ; Patient Compliance ; patient adherence ; patient cooperation ; therapy compliance ; therapy cooperation ; treatment compliance ; compliance behavior ; Evidence based practice ; Adherence ; randomisation ; randomization ; randomly assigned ; Randomized ; Community Practice ; Observational Study ; Observation research ; Observation study ; Observational research ; Small Business Technology Transfer Research ; STTR ; Preparation ; Process ; systematic review ; design ; designing ; novel strategies ; new approaches ; novel approaches ; novel strategy ; Outcome ; innovation ; innovate ; innovative ; user-friendly ; iterative design ; commercialization ; evidence base ; clinical practice ; Problem Sets ; Homework Exercises ; patient engagement ; participant engagement ; practice setting ; effectiveness implementation trial ; effectiveness implementation study ; effectiveness implementation hybrid ; Dissemination and Implementation ; Consolidated Framework for Implementation Research ; Consolidated Framework for Implementation Science ; Consolidated Framework for Implementing Change ; implementation outcomes ;

Phase II

Contract Number: 5R41MH126734-02
Start Date: 7/1/2021    Completed: 5/31/2023
Phase II year
2022
Phase II Amount
$394,769
Homework, or between-session practice of skills learned during therapy, is one of the most integral, yetunderutilized components of high-quality, evidence-based mental health treatments (EBTs) such as CognitiveBehavioral Therapy (CBT). Many providers struggle to consistently develop, assign, and assess homeworkexercises with their patients, and many patients have difficulty remembering to practice skills in a correct andtimely way that fosters adequate learning. Innovative health IT solutions are needed to overcome thesebarriers to implementing this crucial component of high quality EBTs. To meet this need, our experienced teamat Adhere.ly, LLC, in partnership with the University of South Florida, the Medical University of South Carolina,and Doxy.me, LLC developed Adhere.ly, an innovative, state-of-the art, and user-friendly web-based solutionto improve provider implementation and patient engagement in homework during EBTs. Adhere.ly includesengaging therapeutic exercises for providers to introduce, practice, and assign as homework to patients, whoreceive SMS/email reminders with links to practice those exercises during the week. Adhere.ly was initiallydeveloped for providers treating children with PTSD and their caregivers. Broadening Adhere.ly's features andexercises will increase its clinical utility and ability to support NIMH priorities and PA-18-579 Specific Areas ofResearch Interest in "Tools and Platforms to Improve the Dissemination and Implementation of EBTs." Theobjectives of this Phase I STTR proposal-guided by the Accelerated Creation to Sustainment model andModified Consolidated Framework for Implementation Research-are threefold. First, we will seek tounderstand and prioritize key stakeholder goals, challenges, affordances, and constraints by conductingindividual, semi-structured qualitative interviews with adult mental health patients, providers, andadministrators (n≤20 each) and a quantitative survey of 100 providers. We will conduct a mixed methodsanalysis to inform the design of new Adhere.ly features and exercises and an implementation/sustainment (I/S)blueprint (Aim 1). Second, we will use participatory design methodologies (e.g., co-design workshops) withadult mental health patients and providers to iteratively design, refine, and develop new Adhere.ly features andtherapeutic exercises that support a range of adult EBTs, and an I/S blueprint (Aim 2). Third, we will conduct afeasibility Optimization, Effectiveness, and Implementation (OEI) Hybrid trial with 20 community mental healthproviders randomized to CBT+Adhere.ly (n=10) vs. CBT alone (n=10), and 40 treatment seeking,provider-referred adult patients with clinically elevated anxiety and/or depression (outcomes), which we willassess at baseline and 3-months post-baseline. We will assess homework use by providers and adherence ofpatients (targets) weekly via session audio recordings and patient-report. We will optimize new features,exercises, and our I/S plan during the trial and assess implementation outcomes post-implementation (Aim 3).

Public Health Relevance Statement:
PROJECT NARRATIVE Mental health disorders affect 1 in 5 adults in the U.S., yet there is a gap in the quality of mental health care these patients should receive vs. what they do receive. Homework, or between-session practice of skills learned during therapy, is an integral component of high quality, evidence-based mental health care, but its implementation in "real world" clinical settings is generally lacking. This project aims to expand and preliminarily evaluate an innovative, web-based solution to improve the implementation of this crucial component of evidence-based mental health care.

Project Terms:
<21+ years old><0-11 years old>