Feasibility and Effects of Activity Trackers Among Alcohol Users Receiving In-patient Treatment for Alcohol Use Disorder

September 16, 2025 updated by: Alba González-Roz, PhD, University of Oviedo
The main objective is to assess the feasibility and effectiveness of using activity trackers to increase physical activity and improve the emotional state of people receiving an in-patient treatment for alcohol use disorder

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Principality of Asturias
      • Gijón, Principality of Asturias, Spain, 33394
        • Therapeutical community "La Santina"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being 18 years old or older.
  • Be undergoing inpatient treatment for alcohol use disorder.

Exclusion Criteria:

  • Finishing the treatment before 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol use disorder treatment plus Fitbit Versa 3
Participants will receive in-patient treatment for alcohol use disorder plus an activity tracker
Behavioral: Fitbit Versa 3
Fitbit Versa 3 is a commercially available activity tracker
Behavioral: In-patient alcohol use disorder treatment
In-patient alcohol use disorder treatment, including group therapy, counseling, and occupational activities
Active Comparator: Alcohol use disorder treatment
Participants will receive in-patient treatment for alcohol use disorder
Behavioral: In-patient alcohol use disorder treatment
In-patient alcohol use disorder treatment, including group therapy, counseling, and occupational activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity tracker adherence
Time Frame: Treatment duration (4 weeks)
Days (percentage) in which activity tracker was used (day-time and night-time use)
Treatment duration (4 weeks)
Physical activity tracker perceived utility
Time Frame: End-of-treatment (4 weeks)
Perceived utility with the physical activity tracker will be assessed using ad-hoc questions about the utility of the activity tracker to increase levels of physical activity, improve sleep quality, and reduce/abandon tobacco.
End-of-treatment (4 weeks)
Physical activity levels
Time Frame: In-treatment (4 weeks), from enrollment to end-of treatment (4 weeks)
Physical activity (PA) is operationalized as steps per day, plants climbed per day, distance covered per day (kilometers), light physical activity (minutes per day), moderate physical activity (minutes per week), vigorous physical activity (minutes per week), and sedentary time (hours per day). These outcomes will be measured using an adapted version of the International Physical Activity Questionnaire (IPAQ) and Fitbit Versa 3®.
In-treatment (4 weeks), from enrollment to end-of treatment (4 weeks)
Depression symptoms
Time Frame: From enrollment to the end-of-treatment (4 weeks)
Depression symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9). This questionnaire ranges from 0 to 14. A higher punctuation means higher depression symptom levels.
From enrollment to the end-of-treatment (4 weeks)
Anxiety symptoms
Time Frame: From enrollment to the end-of-treatment (4 weeks)
Anxiety symptoms will be measured using Generalized Anxiety Disorder-7 (GAD-7). This questionnaire ranges from 0 to 21. Higher punctuation means higher anxiety levels symptoms.
From enrollment to the end-of-treatment (4 weeks)
Difficulties in emotion regulation
Time Frame: From enrollment to the end-of-treatment (4 weeks)
Emotion dysregulation is measured using the Difficulties in Emotion Regulation Scale (DERS). Emotional dysregulation of negative emotions is measured with the Difficulties in Emotion Regulation Scale (DERS). This scale ranges from 28 to 140 points. A higher score means more difficulties in emotion regulation.
From enrollment to the end-of-treatment (4 weeks)
Physical activity tracker acceptability
Time Frame: End-of-treatment (4 weeks)
Acceptability of the activity tracker is measured using the Participant Experience Questionnaire (PEQ). This scale ranges from 10 to 50 points. A higher score means higher acceptability.
End-of-treatment (4 weeks)
Sleep quality
Time Frame: In-treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)
Sleep quality will be measured using both the Pittsburg Sleep Quality Index (PSQI) and the Fitbit Versa 3. PSQI ranges from 0 to 21 points. A higher score means lower sleep quality. In addition, Fitbit Versa 3 provides a sleep quality punctuation ranging from 0 to 100. A higher punctuation means better sleep quality.
In-treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tobacco use
Time Frame: In treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)
Self-reported cigarettes per day and carbon monoxide (CO) levels measured by a CO monitor reading.
In treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)
Delay discounting (impulsive decision making)
Time Frame: From enrollment to the end-of-treatment (4 weeks)
Delay discounting will be measured using the 21-item Monetary-Choice task. Computerized Delay Discounting task of tobacco (delay of one day, one week, one month, and six months).
From enrollment to the end-of-treatment (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oviedo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 2, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SV-PA-21-AYUD/2021/50884(2)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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