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临床试验/NCT06629493
NCT06629493已完成不适用

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

University of Oviedo2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Physical activity tracker adherence

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Finishing the in-treatment before 4 weeks.

研究组 & 干预措施

Alcohol use disorder treatment plus Fitbit Versa 3

Experimental

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

干预措施: Fitbit Versa 3 (Behavioral)

Alcohol use disorder treatment plus Fitbit Versa 3

Experimental

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

干预措施: In-patient alcohol use disorder treatment (Behavioral)

Alcohol use disorder treatment

Active Comparator

Participants will receive in-patient treatment for alcohol use disorder

干预措施: In-patient alcohol use disorder treatment (Behavioral)

结局指标

主要结局

Physical activity tracker adherence

时间窗: Treatment duration (4 weeks)

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

Physical activity tracker perceived utility

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alba González-Roz, PhD

Professor, PhD

University of Oviedo

研究点 (2)

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