A Tailored Physical Activity Smartphone App for Patients With Alcohol Dependence

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

Inclusion Criteria:

- between 18 and 65 years of age,

- meet DSM-5 criteria for alcohol use disorder as assessed by the SCID-P,

- are sedentary, (i.e., less than 60 minutes of moderate-intensity exercise per week for
the past 6 months), and

- are currently engaged in alcohol treatment.

Exclusion Criteria:

- current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia
nervosa

- a history of psychotic disorder or current psychotic symptoms

- current suicidality or homicidality,

- current mania

- marked organic impairment according to either the medical record or responses to the
diagnostic assessments,

- physical or medical problems that would not allow safe participation in a program of
moderate intensity physical activity (i.e., not medically cleared by study physician),

- current pregnancy or intent to become pregnant during the next 12 weeks.