A Tailored Physical Activity Smartphone App for Patients With Alcohol Dependence

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence
• Intervention / Treatment: Behavioral: Fit&Sober App; Behavioral: Brief Advice

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Advice Plus the Fit&Sober App; Phase 1 (app development & Open Pilot) will consist of: 1) development of the Fit&Sober prototype; 2) series of usability studies with patients with AUDs; and 3) An open pilot of a 12-week trial (n=20) to test the feasibility and acceptability of the Fit&Sober app with patients with AUDs in early recovery. Phase 2: RCT of the Fit&Sober app with 160 patients with AUD	Behavioral: Fit&Sober App; Fit&Sober is a smartphone-based physical activity app that includes multilevel strategies for increasing physical activity for patients with AUDs in early recovery.; Behavioral: Brief Advice; 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
Active Comparator: Brief Advice for Physical Activity; Phase 2: 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	Behavioral: Brief Advice; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minutes of moderate-to-vigorous physical activity per week	Measured by accelerometry	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with App	System Usability Scale	12 Weeks
App Usage	metadata collected from app	12 weeks
Alcohol Abstinence	Percent days abstinence	12-months

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

General Publications

• Abrantes AM, Meshesha LZ, E Blevins C, Battle CL, Lindsay C, Marsh E, Feltus S, Buman M, Agu E, Stein M. A Smartphone Physical Activity App for Patients in Alcohol Treatment: Single-Arm Feasibility Trial. JMIR Form Res. 2022 Oct 19;6(10):e35926. doi: 10.2196/35926.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Smartphone
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 1604-003; R33AA024295 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided