Clinical trial NCT05064228: Mobile Rewarding Activity Centered Treatment
Official title: Mobile Health Intervention to Increase Substance-Free Reward During Alcohol Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Keywords: ecological momentary assessment
ecological momentary intervention
Alcohol Use Disorder Treatment
Adjunctive intervention
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the m-ReACT intervention condition or an active control condition.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timeline Follow-Back - Change in drinking over time
timeFrame: This will be assessed at baseline, 3months, and 6months post baseline
Secondary outcomes:
measure: Reward Probability Index - Change over time
timeFrame: This will be assessed at baseline, 3months, and 6months post baseline
measure: Temporal Experience of Pleasure Scale - Change over time
timeFrame: This will be assessed at baseline, 3months, and 6months post baseline
measure: SF Pleasant Image Ratings - Change over time
timeFrame: This will be assessed at baseline, 3months, and 6months post baseline
Other outcomes:
Locations:
Study officials:
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