A Tailored Physical Activity Smartphone App for Patients With Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title: A Tailored Physical Activity Smartphone App for Patients With Alcohol Dependence

Status Completed

Clinical Trial Summary

The purpose of the study twofold: first, a smartphone-based physical activity application (app), which will be called Fit&Sober, will be developed and tailored specifically for patients with alcohol use disorders (AUDs); then, the feasibility, acceptability, and short-term increases in physical activity with the use of the Fit&Sober app will be examined over the course of a 12-week intervention.

Clinical Trial Description

Alcohol Use Disorders (AUDs) are highly prevalent and a costly public health problem. AUDs are the third leading preventable cause of death in the U.S. and are associated with significant negative physical and psychological health consequences, costing the U.S. economy an estimated $235 billion dollars per year. While progress has occurred in developing treatments for AUDs, relapse rates are still extremely high, ranging from 60-95% in first year following treatment. Given the compelling evidence for the benefits of increased physical activity for physical health, psychological functioning, and drinking outcomes, efforts to help patients with AUDs adopt and sustain increased levels of physical activity (PA) are likely to result in significant public health impact. Capitalizing on the advantages for scalability and dissemination afforded by the use of technology, the investigators will develop a smartphone-based physical activity application (app), which will be called Fit&Sober, tailored specifically for patients with AUDs. Although a number of PA apps exist, the majority suffer from a lack of theory-based concepts known to influence behavior change. Grounded in Self Determination Theory (SDT) and Social Cognitive Theory (SCT), the investigators will develop and tailor the Fit&Sober app for patients with AUDs by designing features that will help patients develop intrinsic, value-driven goals (e.g., exercising for benefits related to sobriety) with a focus on increasing the saliency of immediate rewards associated with PA (e.g., decreased alcohol urges and improved affect). The investigators propose that why someone exercises makes a difference for long-term PA. Early recovery from AUDs, when negative affect is a risk for relapse and urges to drink are common, may be an opportune time to help patients develop internalized, self-determined motivation through experientially making connections between exercise and acute improvements in affect and cravings. Smartphone technology offers unique advantages for self-monitoring these changes in affect and cravings in relation to physical activity. The aims of the proposed study include:

Phase 1: App Development and Open Pilot

1. A Mixed-methods approach will be used to develop a tailored, theoretically-driven smartphone intervention (Fit&Sober App) to help patients in early recovery from AUDs increase levels of physical activity.

1. a. The principles of agile software development will be used to create a prototype of the app. Feedback obtained through a series of usability studies and focus groups with patients with AUDs will iteratively inform subsequent versions of the app.

2. To conduct an open pilot trial with 20 patients with AUDs in early recovery to determine the feasibility, acceptability, and short-term increases in PA with use of the Fit&Sober app. After 12-weeks of app use:

2.a. Through self-report measures and qualitative interviews, feedback will be obtained on use of the Fit&Sober app as well satisfaction with the app, strengths and weaknesses of the app, any challenges encountered with the app, suggestions for areas of improvement, and adverse events.

2.b. Through examination of the Fit&Sober metadata, indicators of the extent of app usage (e.g., days utilized, time spent on the application, components accessed, etc.) will be obtained.

2.c. Through objectively measured PA, short-term increases in physical activity levels will be examined.

Phase 2 -- RCT Aims

1. To conduct a preliminary, randomized controlled trial of the Fit&Sober App compared to Brief Advice (BA) for Exercise among 160 patients in early recovery from AUDs. We hypothesize that, compared to BA, Fit&Sober will be associated with:

1. Higher levels of short-term (3-month) and long-term (6-,12-month), objective-measured moderate-to-vigorous physical activity and sedentary behaviors

2. Higher percent days abstinent (PDA) from alcohol and lower levels of depression and anxiety symptoms at each follow-up

3. Higher levels of theoretically-relevant, PA-related mediating variables including:

self-efficacy, positive outcome expectancies, and self-determined motivation at 3- and 6-month follow-ups

2. To explore the relationship between usage of app features and levels of physical activity engagement ;

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

• NCT number: NCT02958280
• Study type: Interventional
• Source: Butler Hospital
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Completion date: July 30, 2022