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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 : December 10, 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 Behavioral: Fit&Sober App Behavioral: Brief Advice Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel 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 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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




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

  3. Alcohol Abstinence [ Time Frame: 12-months ]
    Percent days abstinence



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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
R33AA024295 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 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