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Clinical Trials/NCT06629493
NCT06629493
Completed
Not Applicable

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

University of Oviedo1 site in 1 country90 target enrollmentApril 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance-Related Disorders
Sponsor
University of Oviedo
Enrollment
90
Locations
1
Primary Endpoint
Physical activity tracker adherence
Status
Completed
Last Updated
7 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 4, 2022
End Date
July 2, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alba González-Roz, PhD

Professor, PhD

University of Oviedo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Finishing the treatment before 4 weeks.

Outcomes

Primary Outcomes

Physical activity tracker adherence

Time Frame: Treatment duration (4 weeks)

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

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.

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®.

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.

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.

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.

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.

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

  • 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 Sites (1)

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