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

NCT05325788 | Completed

• 2 other identifiers: 20000319151F31AA028992-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Opioid Use Disorder

Keywords

intervention development; technology; mHealth; substance use disorder

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Single daily message followed by location-based messaging

OTHER

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; Other: Comparator Condition

Location-based messaging followed by single daily message

OTHER

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; Other: Comparator Condition

Interventions

e-Covery OTHER

Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.

Location-based messaging followed by single daily message; Single daily message followed by location-based messaging

Comparator Condition OTHER

Through the e-Covery app, participants will receive a single general message sent daily in the morning.

Location-based messaging followed by single daily message; Single daily message followed by location-based messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to consent

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

ENRICH Lab

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alcoholism; Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Adam Viera

  Yale University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 13, 2022
• Study Start: November 4, 2022
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)