A Tailored Physical Activity Smartphone App for Patients With Alcohol Dependence
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|ClinicalTrials.gov Identifier: NCT02958280|
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Other: App Development and Open Pilot||Not Applicable|
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:
1. Study Phase 1 (App Development): 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.
- 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.
- Study Phase 2 (Open Pilot): 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Tailored Physical Activity Smartphone App for Patients With Alcohol Dependence|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
App Development and Open Pilot
Phase 1 (app development) will consist of: 1) development of the Fit&Sober prototype; and 2) series of usability studies with patients with AUDs.
Phase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the Fit&Sober app with patients with AUDs in early recovery.
Other: App Development and Open Pilot
Phase 1: Five participants will evaluate the various features of the Fit&Sober app prototype. After an initial period of evaluation of the app, participants will be invited back to participate in a focus group where they will engage in a discussion about the Fit&Sober app.
Phase 2: Twenty patients will be recruited to participate in a 12-week study examining the feasibility and acceptability of the Fit&Sober app.
- Minutes of moderate-to-vigorous physical activity per week [ Time Frame: 12 weeks ]Measured by accelerometry
- Satisfaction with App [ Time Frame: 12 Weeks ]System Usability Scale
- App Usage [ Time Frame: 12 weeks ]metadata collected from app
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958280
|Contact: Ana M Abrantes, Ph.D.||401-455-6440||Ana_Abrantes@Brown.edu|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Contact: Ana M Abrantes, Ph.D. 401-455-6440 Ana_Abrantes@Brown.edu|
|Principal Investigator: Ana M. Abrantes, Ph.D.|