SBIR-STTR Award

Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering from Alcohol Use Disorder
Award last edited on: 5/25/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIAAA
Total Award Amount
$1,827,432
Award Phase
2
Solicitation Topic Code
273
Principal Investigator
Ellen Frank

Company Information

Health Rhythms Inc (AKA: HealthRhythms Inc)

One Broadway 14th Floor
Cambridge, MA 02142
   (412) 246-5550
   info@healthrhythms.com
   www.healthrhythms.com
Location: Single
Congr. District: 07
County: Middlesex

Phase I

Contract Number: 1R44AA028164-01
Start Date: 9/15/2019    Completed: 2/29/2020
Phase I year
2019
Phase I Amount
$250,572
The most recent national surveys indicate that alcohol use disorders adversely affect the well-being, work productivity, financial welfare and families of at least 15 million Americans. Every year a very substantial proportion of the individuals who suffer from alcohol use disorder (AUD) attempt to stop drinking, but somewhere between 40 and 60% will relapse within the first three months. One of the most consistent correlates of early recovery is sleep problems. Importantly, these sleep problems constitute a major risk factor for relapse. While some efforts have been made to address this critical risk factor through targeted interventions, to date these efforts have been limited to small populations of patients and have yet to receive broad dissemination. HealthRhythms, Inc. (www.healthrhythms.com) was founded in 2014 with the goal of using mobile technology to add the layer of behavioral health care to all of healthcare. Our product model capitalizes on the ubiquity and intimacy of smartphones and their capacity to sense parameters of behavior that represent key indicators of behavioral health on a 24/7 basis that are captured in the user’s natural environment. We then build on that measurement to create highly personalized interventions for mental and addictive disorders with a particular focus on sleep/wake and rest/activity regulation. Through our initial SBIR funding, we have built and are currently validating Cue®, a mobile intervention app aimed at regularizing sleep/wake and other behavioral rhythms as a means of ameliorating symptoms of depression and anxiety. We now propose to adapt Cue® to the specific needs of individuals with AUD in early recovery who are experiencing difficulties with sleep. The product we envision will ultimately have three major components: 1) automatic behavioral monitoring via the sensors on the smartphone, 2) psychoeducation about sleep and the complex relationship between sleep and AUD and 3) personalized intervention based on the principles of cognitive behavioral treatment for insomnia (CBT-I) and built upon the individual user’s sensed behavioral profile. The Specific Aims of this Fast Track application are: PHASE I - Aim 1: Achieve a better understanding of the specific sleep difficulties experienced by individuals with AUD who are in the early recovery phase (the first six months of attempted abstinence). Aim 2: Based on the data obtained in these interviews, create a Beta version of the proposed intervention, tentatively called, CueToSleep. PHASE II - Aim 3: Beta test CueToSleep and, based on user feedback, prepare the final version of the app for an adequately-powered RCT. Aim 4: Test the efficacy of CueToSleep in comparison to monitoring alone in terms of its ability to improve sleep and diminish the risk of relapse and examine moderators and mediators of treatment outcome.

Public Health Relevance Statement:
PROJECT NARRATIVE HealthRhythms, Inc. is on a mission to become the world leader in tracking clinically meaningful behavioral health rhythms in order to provide automated intervention advice to patients around the globe. The work we propose in this Fast Track SBIR application will enable HealthRhythms create and test a smartphone application to address the sleep problems experienced by individuals with alcohol use disorder who are in early recovery. Since such sleep problems represent a major risk factor for relapse, this intervention app has the potential to reduce the risk of relapse and, in so doing, improve the lives of individuals with AUD and reduce the costs of their healthcare.

NIH Spending Category:
Alcoholism, Alcohol Use and Health; Behavioral and Social Science; Brain Disorders; Clinical Research; Clinical Trials and Supportive Activities; Depression; Mental Health; Mental Illness; Neurosciences; Precision Medicine; Prevention; Sleep Research; Substance Abuse

Project Terms:
Abstinence; addiction; Address; Affect; alcohol abstinence; alcohol use disorder; American; Anxiety; base; Behavior; Behavior monitoring; Behavior Therapy; Behavioral; behavioral health; Cellular Phone; Circadian Rhythms; Clinical; Cognitive Therapy; Complex; cost; Cues; Data; depressive symptoms; Development; drinking; Education; efficacy testing; Environment; experience; Family; Feedback; Follow-Up Studies; Funding; Goals; Grant; Health; Healthcare; Heart Diseases; Hygiene; Hypertension; immune function; improved; indexing; Individual; interest; Intervention; Interview; intimate behavior; Measurement; Measures; Mediating; Mediation; Mediator of activation protein; member; Mental Depression; Mental disorders; Mission; mobile application; mobile computing; Modeling; Monitor; Outcome; Participant; Pathway interactions; patient population; Patients; Personal Satisfaction; personalized intervention; Phase; Polysomnography; Population; primary outcome; Productivity; psychoeducation; psychoeducational intervention; Qualitative Methods; Randomized Controlled Trials; Recovery; reduce symptoms; Regulation; Relapse; relapse risk; Rest; Risk; Risk Factors; Role; secondary outcome; sensor; Series; Severities; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Small Business Innovation Research Grant; smartphone Application; social; Structure; Surveys; Technology; Telephone; Testing; Treatment outcome; Universities; Utah; welfare; Work

Phase II

Contract Number: 4R44AA028164-02
Start Date: 9/15/2019    Completed: 2/28/2022
Phase II year
2020
(last award dollars: 2021)
Phase II Amount
$1,576,860

The most recent national surveys indicate that alcohol use disorders adversely affect the well-being, work productivity, financial welfare and families of at least 15 million Americans. Every year a very substantial proportion of the individuals who suffer from alcohol use disorder (AUD) attempt to stop drinking, but somewhere between 40 and 60% will relapse within the first three months. One of the most consistent correlates of early recovery is sleep problems. Importantly, these sleep problems constitute a major risk factor for relapse. While some efforts have been made to address this critical risk factor through targeted interventions, to date these efforts have been limited to small populations of patients and have yet to receive broad dissemination. HealthRhythms, Inc. (www.healthrhythms.com) was founded in 2014 with the goal of using mobile technology to add the layer of behavioral health care to all of healthcare. Our product model capitalizes on the ubiquity and intimacy of smartphones and their capacity to sense parameters of behavior that represent key indicators of behavioral health on a 24/7 basis that are captured in the user’s natural environment. We then build on that measurement to create highly personalized interventions for mental and addictive disorders with a particular focus on sleep/wake and rest/activity regulation. Through our initial SBIR funding, we have built and are currently validating Cue®, a mobile intervention app aimed at regularizing sleep/wake and other behavioral rhythms as a means of ameliorating symptoms of depression and anxiety. We now propose to adapt Cue® to the specific needs of individuals with AUD in early recovery who are experiencing difficulties with sleep. The product we envision will ultimately have three major components: 1) automatic behavioral monitoring via the sensors on the smartphone, 2) psychoeducation about sleep and the complex relationship between sleep and AUD and 3) personalized intervention based on the principles of cognitive behavioral treatment for insomnia (CBT-I) and built upon the individual user’s sensed behavioral profile. The Specific Aims of this Fast Track application are: PHASE I - Aim 1: Achieve a better understanding of the specific sleep difficulties experienced by individuals with AUD who are in the early recovery phase (the first six months of attempted abstinence). Aim 2: Based on the data obtained in these interviews, create a Beta version of the proposed intervention, tentatively called, CueToSleep. PHASE II - Aim 3: Beta test CueToSleep and, based on user feedback, prepare the final version of the app for an adequately-powered RCT. Aim 4: Test the efficacy of CueToSleep in comparison to monitoring alone in terms of its ability to improve sleep and diminish the risk of relapse and examine moderators and mediators of treatment outcome.

Public Health Relevance Statement:
PROJECT NARRATIVE HealthRhythms, Inc. is on a mission to become the world leader in tracking clinically meaningful behavioral health rhythms in order to provide automated intervention advice to patients around the globe. The work we propose in this Fast Track SBIR application will enable HealthRhythms create and test a smartphone application to address the sleep problems experienced by individuals with alcohol use disorder who are in early recovery. Since such sleep problems represent a major risk factor for relapse, this intervention app has the potential to reduce the risk of relapse and, in so doing, improve the lives of individuals with AUD and reduce the costs of their healthcare.

Project Terms:
Abstinence; addiction; Address; Affect; alcohol abstinence; alcohol use disorder; American; Anxiety; base; Behavior; Behavior monitoring; Behavior Therapy; Behavioral; behavioral health; Cellular Phone; Circadian Rhythms; Clinical; Cognitive Therapy; Complex; cost; Cues; Data; depressive symptoms; Development; drinking; Education; efficacy testing; Environment; experience; Family; Feedback; Follow-Up Studies; Funding; Goals; Grant; Health; Healthcare; Heart Diseases; Hygiene; Hypertension; immune function; improved; indexing; Individual; interest; Intervention; Interview; intimate behavior; Measurement; Measures; Mediating; Mediation; Mediator of activation protein; member; Mental Depression; Mental disorders; Mission; mobile application; mobile computing; Modeling; Monitor; Outcome; Participant; Pathway interactions; patient population; Patients; Personal Satisfaction; personalized intervention; Phase; Polysomnography; Population; primary outcome; Productivity; psychoeducation; psychoeducational intervention; Qualitative Methods; Randomized Controlled Trials; Recovery; reduce symptoms; Regulation; Relapse; relapse risk; Rest; Risk; Risk Factors; Role; secondary outcome; sensor; Series; Severities; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Small Business Innovation Research Grant; smartphone Application; social; Structure; Surveys; Technology; Telephone; Testing; Treatment outcome; Universities; Utah; welfare; Work