Mobile Rewarding Activity Centered Treatment

NCT05064228 | Unknown

• 1 other identifier: AWD00000705
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Use Disorder (AUD)

Keywords

ecological momentary assessment; ecological momentary intervention; Alcohol Use Disorder Treatment; Adjunctive intervention

Outcome Measures

Primary Outcomes (1)

• 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

  This will be assessed at baseline, 3months, and 6months post baseline

Secondary Outcomes (3)

• Reward Probability Index - Change over time

  This will be assessed at baseline, 3months, and 6months post baseline

• Temporal Experience of Pleasure Scale - Change over time

  This will be assessed at baseline, 3months, and 6months post baseline

• SF Pleasant Image Ratings - Change over time

  This will be assessed at baseline, 3months, and 6months post baseline

Study Arms (2)

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.

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.

Behavioral: Mobile Rewarding Activity Centered Treatment (m-ReACT)

Interventions

Mobile Rewarding Activity Centered Treatment (m-ReACT) BEHAVIORAL

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.

Brief Advice; m-ReACT app condition

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 65 years of age
• primary DMS-5 diagnosis of AUD
• currently enrolled in outpatient treatment of AUD
• Own a smarphone

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lidia Meshesha, PhD

CONTACT

407-823-1868; lidia.meshesha@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to either the m-ReACT intervention condition or an active control condition.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 1, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: As data gets collected starting December 2023 throughout end of data collection with no planned end date
• Access Criteria: Individuals or organizations with access to NIH Data Archive