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

NCT06629493 | Completed

• 1 other identifier: SV-PA-21-AYUD/2021/50884(2)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Substance-Related Disorders; Alcohol-Related Disorders; Alcohol Use Disorder (AUD)

Keywords

activity tracker; alcohol use disorder; physical activity; treatment; mental health

Outcome Measures

Primary Outcomes (8)

• Physical activity tracker adherence

  Days (percentage) in which activity tracker was used (day-time and night-time use)

  Treatment duration (4 weeks)

• Physical activity tracker perceived utility

  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

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Tobacco use

  In treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)

• Delay discounting (impulsive decision making)

  From enrollment to the end-of-treatment (4 weeks)

Study Arms (2)

Alcohol use disorder treatment plus Fitbit Versa 3

EXPERIMENTAL

Participants will receive in-patient treatment for alcohol use disorder plus an activity tracker

Behavioral: Fitbit Versa 3; Behavioral: In-patient alcohol use disorder treatment

Alcohol use disorder treatment

ACTIVE COMPARATOR

Participants will receive in-patient treatment for alcohol use disorder

Behavioral: In-patient alcohol use disorder treatment

Interventions

Fitbit Versa 3 BEHAVIORAL

Fitbit Versa 3 is a commercially available activity tracker

Alcohol use disorder treatment plus Fitbit Versa 3

In-patient alcohol use disorder treatment BEHAVIORAL

In-patient alcohol use disorder treatment, including group therapy, counseling, and occupational activities

Alcohol use disorder treatment; Alcohol use disorder treatment plus Fitbit Versa 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Finishing the treatment before 4 weeks.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Therapeutical community "La Santina"

Gijón, Principality of Asturias, 33394, Spain

Location

Related Publications (4)

• Scott CK, Dennis ML, Gustafson DH. Reprint of Using ecological momentary assessments to predict relapse after adult substance use treatment. Addict Behav. 2018 Aug;83:116-122. doi: 10.1016/j.addbeh.2018.04.003. Epub 2018 Apr 7.

  PMID: 29661655 BACKGROUND

• Purani H, Friedrichsen S, Allen AM. Sleep quality in cigarette smokers: Associations with smoking-related outcomes and exercise. Addict Behav. 2019 Mar;90:71-76. doi: 10.1016/j.addbeh.2018.10.023. Epub 2018 Oct 17.

  PMID: 30368021 BACKGROUND

• Brickwood KJ, Watson G, O'Brien J, Williams AD. Consumer-Based Wearable Activity Trackers Increase Physical Activity Participation: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2019 Apr 12;7(4):e11819. doi: 10.2196/11819.

  PMID: 30977740 BACKGROUND

• Abrantes AM, Blevins CE, Battle CL, Read JP, Gordon AL, Stein MD. Developing a Fitbit-supported lifestyle physical activity intervention for depressed alcohol dependent women. J Subst Abuse Treat. 2017 Sep;80:88-97. doi: 10.1016/j.jsat.2017.07.006. Epub 2017 Jul 8.

  PMID: 28755778 BACKGROUND

Related Links

• Fitbit webpage, where information about the the device used in the trial can be found

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol-Related Disorders; Alcoholism; Motor Activity; Psychological Well-Being

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: October 8, 2024
• Study Start: April 4, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 2, 2025
• Last Updated: September 22, 2025

Record last verified: 2024-10

Locations

ES (1)