Alcohol Use Disorder (AUD)mReACTNCT05064228
Mobile Rewarding Activity Centered Treatment
A study testing Mobile Rewarding Activity Centered Treatment (m-ReACT) in people with Alcohol Use Disorder (AUD), run by University of Central Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Mobile Rewarding Activity Centered Treatment (m-ReACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 65 years of age
- primary DMS-5 diagnosis of AUD
- currently enrolled in outpatient treatment of AUD
- Own a smarphone
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mobile Health Intervention to Increase Substance-Free Reward During Alcohol Treatment
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.
Read the 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Mobile Rewarding Activity Centered Treatment (m-ReACT)
- Keywords
- ecological momentary assessment, ecological momentary intervention, Alcohol Use Disorder Treatment, Adjunctive intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Rewarding Activity Centered Treatment (m-ReACT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| m-ReACT app condition | Experimental | 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. Receives: Behavioral: Mobile Rewarding Activity Centered Treatment (m-ReACT) |
| Brief Advice | Active comparator | Participants will be given a one time brief informational session on the importance of engaging in substance-free activity while in AUD treatment. Receives: Behavioral: Mobile Rewarding Activity Centered Treatment (m-ReACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: This will be assessed at baseline, 3months, and 6months post baseline
Secondary outcomes (3)
Reward Probability Index - Change over time
The study will assess change in for RPI substance free reinforcement
Measured: This will be assessed at baseline, 3months, and 6months post baseline
Temporal Experience of Pleasure Scale - Change over time
Assess change over time in experience of pleasure as a measure of substance free reinforcement
Measured: This will be assessed at baseline, 3months, and 6months post baseline
SF Pleasant Image Ratings - Change over time
Assess change over time in objective pleasant image ratings as a measure of substance free reinforcement
Measured: This will be assessed at baseline, 3months, and 6months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the m-ReACT intervention condition or an active control condition.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidia Meshesha, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064228
- Sponsor's protocol ID
- AWD00000705
- Acronym
- mReACT
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data will be shared with NIH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Intervention to Increase Substance-Free Reward During Alcohol Treatment
- ClinicalTrials.gov ID
- NCT05064228
- Acronym / sponsor ID
- mReACT / AWD00000705
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- ecological momentary assessment, ecological momentary intervention, Alcohol Use Disorder Treatment, Adjunctive intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the m-ReACT intervention condition or an active control condition.
| Arm | Type | Receives |
|---|---|---|
| m-ReACT app condition | Experimental | Behavioral: Mobile Rewarding Activity Centered Treatment (m-ReACT)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. |
| Brief Advice | Active comparator | Behavioral: Mobile Rewarding Activity Centered Treatment (m-ReACT)Participants will be given a one time brief informational session on the importance of engaging in substance-free activity while in AUD treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 65 years of age
- primary DMS-5 diagnosis of AUD
- currently enrolled in outpatient treatment of AUD
- Own a smarphone
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Rewarding Activity Centered Treatment (m-ReACT)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. | Behavioural | Brief Advice, m-ReACT app condition |
Primary outcome
Timeline Follow-Back - Change in drinking over time
Time frame: This will be assessed at baseline, 3months, and 6months post baseline
The 90-day timeline follow-back will be used to asses change over time in percent days abstinent from alcohol
3 secondary outcomes
Reward Probability Index - Change over time
Time frame: This will be assessed at baseline, 3months, and 6months post baseline
Temporal Experience of Pleasure Scale - Change over time
Time frame: This will be assessed at baseline, 3months, and 6months post baseline
SF Pleasant Image Ratings - Change over time
Time frame: This will be assessed at baseline, 3months, and 6months post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: Yes. Deidentified study data will be shared with NIH Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Rewarding Activity Centered Treatment (m-ReACT) in people with Alcohol Use Disorder (AUD), run by University of Central Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lidia Meshesha, PhD (407-823-1868, lidia.meshesha@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeline Follow-Back - Change in drinking over time (time frame: This will be assessed at baseline, 3months, and 6months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.