Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use

Study Overview
=================
Brief Summary
-----------------
This project aims to improve the health of individuals engaged in co-occurring alcohol and opioid use by supporting the maintenance of behavior change initiated in substance use treatment. Building on prior research, this study will entail a stage 1b pilot to test the feasibility and acceptability of an app-based intervention for individuals reporting co-occurring alcohol and opioid use. The intervention will involve modifying an app currently used in a research study to collect GPS information to send push notifications when individuals encounter self-identified place-based triggers. Thirty individuals completing substance use treatment will consent to use the app for a thirty-day pilot period and will complete assessments of intervention feasibility and acceptability. Using within-subject tests, the analysis will summarize participant responses to assessments and will compare the use of general messaging to place-specific messaging.

Detailed Description
-----------------
Co-occurring alcohol and opioid use is a public health issue in need of attention and has been linked to various health concerns, such as motor vehicle accidents and drug poisoning and overdose. Individuals engaged in polysubstance use face myriad challenges in sustaining recovery after completion of substance use treatment and return to use after treatment completion is common. One challenge faced by individuals in early recovery is how specific places can serve as triggers for cravings that can precipitate return to use. Smartphone apps have the potential to curtail the effects of such triggers by providing messaging (or nudging) when individuals are in locations identified as triggers of return to use. To date, research on app-based interventions has yet to examine the effect of such nudging independently and has not looked at its effectiveness in addressing co-occurring alcohol and opioid use. This project aims to improve the health of individuals engaged in co-occurring alcohol and opioid use by supporting the maintenance of behavior change initiated in substance use treatment. Building on prior research, this study will entail a stage 1b pilot to test the feasibility and acceptability of an app-based intervention for individuals reporting co-occurring alcohol and opioid use. The intervention will involve modifying an app currently used in a research study to collect GPS information to send push notifications when individuals encounter self-identified place-based triggers. Thirty individuals completing substance use treatment will consent to use the app for a thirty-day pilot period and will complete assessments of intervention feasibility and acceptability. Using within-subject tests, the analysis will summarize participant responses to assessments and will compare the use of general messaging to place-specific messaging.

Official Title
-----------------
Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use

Conditions
-----------------
Alcohol Use Disorder, Opioid Use Disorder

Intervention / Treatment
-----------------
* Other: e-Covery
* Other: Comparator Condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: speak English report enrollment in a substance use treatment program at baseline report use above the screening tool thresholds for problem alcohol use own a smartphone reside in Connecticut at baseline with no plans to move in the following month Exclusion Criteria: Inability to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single daily message followed by location-based messaging<br>Participants in this condition receive a single daily message through the intervention app for two weeks (14 days) followed by location-based messaging for two weeks (14 days). | Other: e-Covery<br>* Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.<br>Other: Comparator Condition<br>* Through the e-Covery app, participants will receive a single general message sent daily in the morning.<br>|
| Other: Location-based messaging followed by single daily message<br>Participants in this condition receive location-based messaging through the intervention app for two weeks (14 days) followed by a single daily message for two weeks (14 days) . | Other: e-Covery<br>* Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.<br>Other: Comparator Condition<br>* Through the e-Covery app, participants will receive a single general message sent daily in the morning.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the e-Covery app measured by average time spent using the app assessed at day 28 | Feasibility is assessed by average time spent using the app, measured through app usage metrics. More time spent using the app indicates more engagement. | Day 28 | 
| Feasibility of the e-Covery app assessed through qualitative interviews | Feasibility is assessed based on participant responses to questions during an interview taking place after the 28-day pilot period. Participants will be asked about the ease of using the e-Covery app and responses will be coded and analyzed to identify themes related to feasibility. Qualitative findings will be compared to the quantitative findings above using an integrated analysis characteristics of mixed methods approaches. | Day 28 | 
| Average acceptability rating of the e-Covery app measured by 5-point Likert scale | Average acceptability is assessed at Days 14 and 28 based on participants' opinion of and satisfaction with the intervention, measured through completion of daily surveys assessing elements of acceptability using Likert scale response options. Higher ratings correspond to higher intervention acceptability. Intent of the outcome measure is to assess the average score from Day 1 through Day 14 compared to the average score from Day 15 through Day 28 to compare the average ratings between conditions. | up to Day 28 | 
| Acceptability of the e-Covery app assessed through qualitative interviews | Acceptability is assessed based on participant responses to questions during an interview taking place after the 28-day pilot period. Participants will be asked about their satisfaction with the e-Covery app and intervention and responses will be coded and analyzed to identify themes related to acceptability. Qualitative findings will be compared to the quantitative findings above using an integrated analysis characteristics of mixed methods approaches. | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
technology, intervention development, mHealth, substance use disorder