A Tailored Physical Activity Smartphone App for Patients With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

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.
    

Detailed 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
    

Intervention name(s): Fit&Sober App; Brief Advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Fit&Sober is a smartphone-based physical activity app that includes multilevel strategies for increasing physical activity for patients with AUDs in early recovery.; Participants randomized to the BA only condition will meet for a 30-minute discussion with a research staff member. In this session, participants will receive information about the public health guidelines for physical activity, the benefits of physical activity for physical and mental health, as well as sobriety, strategies for getting started as well as instruction on gradually increasing physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Smartphone