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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol use disorder treatment plus Fitbit Versa 3 | Experimental | Participants will receive in-patient treatment for alcohol use disorder plus an activity tracker |
|
| Alcohol use disorder treatment | Active Comparator | Participants will receive in-patient treatment for alcohol use disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit Versa 3 | Behavioral | Fitbit Versa 3 is a commercially available activity tracker |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco use | Self-reported cigarettes per day and carbon monoxide (CO) levels measured by a CO monitor reading. | In treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks) |
| Delay discounting (impulsive decision making) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutical community "La Santina" | Gijón | Principality of Asturias | 33394 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29661655 | Background | 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. | |
| 30368021 | 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. |
| Label | URL |
|---|---|
| Fitbit webpage, where information about the the device used in the trial can be found | View source |
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| In-patient alcohol use disorder treatment | Behavioral | In-patient alcohol use disorder treatment, including group therapy, counseling, and occupational activities |
|
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) |
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).
| From enrollment to the end-of-treatment (4 weeks) |
| 30977740 | 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. |
| 28755778 | 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. |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D019973 | Alcohol-Related Disorders |
| D000437 | Alcoholism |
| D009043 | Motor Activity |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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