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Completed

NCT Number: NCT06629493

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

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

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Key information

Conditions

Substance-related Disorders Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Mental Disorders Motor Activity Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Therapeutical community "La Santina"

Gijón, Principality of Asturias, 33394, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Finishing the in-treatment before 4 weeks.

Treatment and study plan

Fitbit Versa 3

Behavioral

Fitbit Versa 3 is a commercially available activity tracker

In-patient alcohol use disorder treatment

Behavioral

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

Primary outcomes

  1. Physical activity tracker adherence

    Time frame: Treatment duration (4 weeks)

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

  2. 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.

  3. 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®.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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