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

Primary Purpose

Alcohol Use Disorder, Opioid Use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-Covery
Comparator Condition
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring intervention development, technology, mHealth, substance use disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ENRICH Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Single daily message followed by location-based messaging

Location-based messaging followed by single daily message

Arm Description

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).

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) .

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2022
Last Updated
October 11, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05325788
Brief Title
Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use
Official Title
Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Opioid Use Disorder
Keywords
intervention development, technology, mHealth, substance use disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single daily message followed by location-based messaging
Arm Type
Other
Arm Description
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).
Arm Title
Location-based messaging followed by single daily message
Arm Type
Other
Arm Description
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) .
Intervention Type
Other
Intervention Name(s)
e-Covery
Intervention Description
Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.
Intervention Type
Other
Intervention Name(s)
Comparator Condition
Intervention Description
Through the e-Covery app, participants will receive a single general message sent daily in the morning.
Primary Outcome Measure Information:
Title
Feasibility of the e-Covery app measured by average time spent using the app assessed at day 28
Description
Feasibility is assessed by average time spent using the app, measured through app usage metrics. More time spent using the app indicates more engagement.
Time Frame
Day 28
Title
Feasibility of the e-Covery app assessed through qualitative interviews
Description
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.
Time Frame
Day 28
Title
Average acceptability rating of the e-Covery app measured by 5-point Likert scale
Description
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.
Time Frame
up to Day 28
Title
Acceptability of the e-Covery app assessed through qualitative interviews
Description
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.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Viera
Organizational Affiliation
Yale University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
ENRICH Lab
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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