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Trial record 16 of 123 for:    Recruiting, Not yet recruiting, Available Studies | "Alcoholism"

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
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Butler Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Other: App Development and Open Pilot Not Applicable

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:

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.

  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. 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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Minutes of moderate-to-vigorous physical activity per week [ Time Frame: 12 weeks ]
    Measured by accelerometry


Secondary Outcome Measures :
  1. Satisfaction with App [ Time Frame: 12 Weeks ]
    System Usability Scale

  2. App Usage [ Time Frame: 12 weeks ]
    metadata collected from app



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Ana M Abrantes, Ph.D. 401-455-6440 Ana_Abrantes@Brown.edu

Locations
United States, Rhode Island
Butler Hospital Recruiting
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.         
Sponsors and Collaborators
Butler Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT02958280     History of Changes
Other Study ID Numbers: 1604-003
R21AA024295 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Butler Hospital:
Exercise
Smartphone

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders