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

Not Applicable

Recruiting

• Conditions: Substance-Related Disorders; Alcohol-Related Disorders; Alcohol Use Disorder (AUD)
• Interventions: Behavioral: Fitbit Versa 3; Behavioral: In-patient alcohol use disorder treatment

• Registration Number: NCT06629493
• Lead Sponsor: University of Oviedo

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Study First Submitted: 2024-07-30
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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Exclusion Criteria

• Finishing the treatment before 4 weeks.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol use disorder treatment plus Fitbit Versa 3	Fitbit Versa 3	Participants will receive in-patient treatment for alcohol use disorder plus an activity tracker
Alcohol use disorder treatment plus Fitbit Versa 3	In-patient alcohol use disorder treatment	Participants will receive in-patient treatment for alcohol use disorder plus an activity tracker
Alcohol use disorder treatment	In-patient alcohol use disorder treatment	Participants will receive in-patient treatment for alcohol use disorder

Primary Outcome Measures

Name	Time	Method
Physical activity tracker adherence	Treatment duration (4 weeks)	Days (percentage) in which activity tracker was used (day-time and night-time use)
Physical activity tracker perceived utility	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.
Physical activity levels	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®.
Depression symptoms	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.
Anxiety symptoms	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.
Difficulties in emotion regulation	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.
Physical activity tracker acceptability	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.
Sleep quality	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 Outcome Measures

Name	Time	Method
Tobacco use	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.
Delay discounting (impulsive decision making)	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).

Trial Locations

Locations (1)

Therapeutical community "La Santina"; 🇪🇸 Gijón, Asturias, Spain