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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
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Between 18 and 65 years of age
  2. primary DMS-5 diagnosis of AUD
  3. currently enrolled in outpatient treatment of AUD
  4. Own a smarphone

Exclusion Criteria:

  1. enrolled to attend higher level of care (i.e., inpatient or residential treatment) after discharge from current outpatient treatment program
  2. a history of psychotic disorder or current psychotic symptoms
  3. current suicidal or homicidal ideation
  4. 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

    First Posted
    September 3, 2021
    Last Updated
    September 30, 2021
    Sponsor
    University of Central Florida
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    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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