Mobile Rewarding Activity Centered Treatment (mReACT)
Primary Purpose
Alcohol Use Disorder (AUD)
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Rewarding Activity Centered Treatment (m-ReACT)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder (AUD) focused on measuring ecological momentary assessment, ecological momentary intervention, Alcohol Use Disorder Treatment, Adjunctive intervention
Eligibility Criteria
Inclusion Criteria:
- Between 18 and 65 years of age
- primary DMS-5 diagnosis of AUD
- currently enrolled in outpatient treatment of AUD
- Own a smarphone
Exclusion Criteria:
- enrolled to attend higher level of care (i.e., inpatient or residential treatment) after discharge from current outpatient treatment program
- a history of psychotic disorder or current psychotic symptoms
- current suicidal or homicidal ideation
- moderate or severe DSM-5 substance use disorders other than alcohol or nicotine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
m-ReACT app condition
Brief Advice
Arm Description
Participants will download the m-ReACT app on their mobile phones and will be asked to engage with the app for a period of 12 weeks.
Participants will be given a one time brief informational session on the importance of engaging in substance-free activity while in AUD treatment.
Outcomes
Primary Outcome Measures
Timeline Follow-Back - Change in drinking over time
The 90-day timeline follow-back will be used to asses change over time in percent days abstinent from alcohol
Secondary Outcome Measures
Reward Probability Index - Change over time
The study will assess change in for RPI substance free reinforcement
Temporal Experience of Pleasure Scale - Change over time
Assess change over time in experience of pleasure as a measure of substance free reinforcement
SF Pleasant Image Ratings - Change over time
Assess change over time in objective pleasant image ratings as a measure of substance free reinforcement
Full Information
NCT ID
NCT05064228
First Posted
September 3, 2021
Last Updated
September 30, 2021
Sponsor
University of Central Florida
1. Study Identification
Unique Protocol Identification Number
NCT05064228
Brief Title
Mobile Rewarding Activity Centered Treatment
Acronym
mReACT
Official Title
Mobile Health Intervention to Increase Substance-Free Reward During Alcohol Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Florida
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
Alcohol Use Disorder (AUD) is a highly prevalent and significant public health problem. Behavioral treatments based in the principles of social learning theory and cognitive behavior therapy have been developed and tested for AUD, yet effect sizes are relatively small and rates of relapse following treatment are high. Theoretically informed adjunctive interventions may help to enhance the effects of extant AUD treatments. In particular, evidence suggests that environments lacking in substance-free (SF) activities contribute to the development and maintenance of AUD and that the availability of rewarding SF activities may serve as viable alternatives to compete with alcohol use. Building on the advantages of accessibility and low-cost option afforded by the use of mobile technology, this proposal outlines a well-integrated research and training plan to investigate a mobile health intervention to increase engagement in rewarding SF activities among patients in AUD treatment. This proposed research aims to develop and evaluate a mobile phone ecological momentary assessment plus ecological momentary intervention (EMA+EMI; entitled: mobile - Rewarding Activity Centered Treatment (m-ReACT)) app to augment existing AUD treatment. The m-ReACT app will monitor self-reported rewarding SF activity engagement in real-time and deliver personalized feedback that encourages participants to engage in highly rewarding activities that are goal-oriented and support positive treatment outcomes. This proposed intervention will be developed in two phases. Phase 1 will develop the m-ReACT app and Phase 2 will evaluate its efficacy in randomized control pilot trial with a sample of 50 AUD patients who have recently initiated outpatient AUD treatment. Participants in the pilot RCT will be randomly assigned to either the m-ReACT condition or an active control condition. It is hypothesized that m-ReACT will result in increased rates of percent days of alcohol abstinence and increased reinforcement from SF activities.
Detailed Description
Alcohol use disorder (AUD) is strongly linked with deficits in alcohol-free alternative rewards. Individuals with AUD have limited sources of substance-free (SF) natural rewards. Increasing SF rewards in the context of treatment is of immediate public health relevance as it has the potential to improve AUD treatment outcomes. Yet, this is not a focus of standard outpatient treatment. Prior studies demonstrate that interventions focused on SF alternatives in addition to standard treatment improve outcomes above and beyond standard treatment alone. However, these efficacious treatments can be difficult to implement and sustain within a real-world AUD treatment facility. Therefore, it is essential to enhance the approach used in these studies to meet the needs of patients and treatment facilities alike. Novel methodologies that are cost effective, technologically enhanced, and less time intensive are needed to better incorporate this intervention within a treatment setting. The proposed study would make use of mobile technology to aid patients engage in alternative behaviors, who otherwise may have limited access to activities other than drinking, and thereby potentially help reduce risk of relapse.
This research proposal aims to develop and evaluate an ecological momentary intervention (EMI) supported by an ecological momentary assessment (EMA) aimed at increasing reinforcement from substance-free activities among AUD patients in order to improve treatment outcomes. Towards this end, this research will be conducted in two phases. Phase 1 will entail an iterative process of EMA plus EMI development of a smartphone app, called mobile-Rewarding Activity Centered Treatment (m-ReACT), designed to collect real-time data on substance-free activity engagement and obtained reward. The data will then be provided back to the individuals to encourage engagement in activities that were most rewarding.
Upon app successful app development, this study will implement phase 2. Phase 2 will consist of a pilot RCT (N=50) to evaluate m-ReACT as an adjunctive intervention for AUD treatment-seekers compared to a brief advice (BA) session on engaging in SF pleasant activities. Participants will be randomized to either an in-person informational session consisting of BA on the importance of engaging in SF rewarding activities or brief in-person app orientation session that will collect daily reporting of substance free activity engagement and enjoyment and provide personalized feedback on level of substance free activity engagement and enjoyment with encouragement to continue engagement. Feasibility and acceptability of m-ReACT will be assessed with self-report measures, qualitative end-of treatment interviews, and examination of app usage from the app metadata. Follow-up assessments will be conducted at 3 (end of treatment) and 6-months to evaluate for drinking related outcomes and SF reinforcement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
ecological momentary assessment, ecological momentary intervention, Alcohol Use Disorder Treatment, Adjunctive intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either the m-ReACT intervention condition or an active control condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
m-ReACT app condition
Arm Type
Experimental
Arm Description
Participants will download the m-ReACT app on their mobile phones and will be asked to engage with the app for a period of 12 weeks.
Arm Title
Brief Advice
Arm Type
Active Comparator
Arm Description
Participants will be given a one time brief informational session on the importance of engaging in substance-free activity while in AUD treatment.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Rewarding Activity Centered Treatment (m-ReACT)
Intervention Description
Participants will utilize m-ReACT for 12-weeks, reporting daily on substance-free activity engagement and enjoyment (EMA). m-ReACT will utilize these EMA reports to generate brief, automated, and personalized feedback about enjoyed categories of substance-free activities as well as make suggestions for increasing engagement in those rewarding, goal-oriented substance-free activities, and provide personalized suggestions of activities of interest.
Primary Outcome Measure Information:
Title
Timeline Follow-Back - Change in drinking over time
Description
The 90-day timeline follow-back will be used to asses change over time in percent days abstinent from alcohol
Time Frame
This will be assessed at baseline, 3months, and 6months post baseline
Secondary Outcome Measure Information:
Title
Reward Probability Index - Change over time
Description
The study will assess change in for RPI substance free reinforcement
Time Frame
This will be assessed at baseline, 3months, and 6months post baseline
Title
Temporal Experience of Pleasure Scale - Change over time
Description
Assess change over time in experience of pleasure as a measure of substance free reinforcement
Time Frame
This will be assessed at baseline, 3months, and 6months post baseline
Title
SF Pleasant Image Ratings - Change over time
Description
Assess change over time in objective pleasant image ratings as a measure of substance free reinforcement
Time Frame
This will be assessed at baseline, 3months, and 6months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 18 and 65 years of age
primary DMS-5 diagnosis of AUD
currently enrolled in outpatient treatment of AUD
Own a smarphone
Exclusion Criteria:
enrolled to attend higher level of care (i.e., inpatient or residential treatment) after discharge from current outpatient treatment program
a history of psychotic disorder or current psychotic symptoms
current suicidal or homicidal ideation
moderate or severe DSM-5 substance use disorders other than alcohol or nicotine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lidia Meshesha, PhD
Phone
407-823-1868
Email
lidia.meshesha@ucf.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified study data will be shared with NIH Data Archive
IPD Sharing Time Frame
As data gets collected starting December 2023 throughout end of data collection with no planned end date
IPD Sharing Access Criteria
Individuals or organizations with access to NIH Data Archive
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Mobile Rewarding Activity Centered Treatment
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