Substance-Related DisordersNCT06629493
Feasibility and Effects of Activity Trackers Among Alcohol Users Receiving In-patient Treatment for Alcohol Use Disorder
A study testing Fitbit Versa 3 and In-patient alcohol use disorder treatment in people with Substance-Related Disorders and Alcohol-Related Disorders, run by University of Oviedo at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders, Alcohol-Related Disorders, Alcohol Use Disorder (AUD)
- What is being tested?
- Fitbit Versa 3 and In-patient alcohol use disorder treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years old or older.
- Be undergoing inpatient treatment for alcohol use disorder.
Who cannot join
- Finishing the in-treatment before 4 weeks.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Therapeutical community "La Santina"
Gijón, Principality of Asturias, 33394
About this study
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
- Being tested
- Fitbit Versa 3, In-patient alcohol use disorder treatment
- Keywords
- activity tracker, alcohol use disorder, physical activity, treatment, mental health
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders, Alcoholism, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Versa 3Behavioural
Fitbit Versa 3 is a commercially available activity tracker
In-patient alcohol use disorder treatmentBehavioural
In-patient alcohol use disorder treatment, including group therapy, counseling, and occupational activities
| Study group | Role | What they receive |
|---|---|---|
| Alcohol use disorder treatment plus Fitbit Versa 3 | Experimental | Participants will receive in-patient treatment for alcohol use disorder plus an activity tracker Receives: Behavioral: Fitbit Versa 3; Behavioral: In-patient alcohol use disorder treatment |
| Alcohol use disorder treatment | Active comparator | Participants will receive in-patient treatment for alcohol use disorder Receives: Behavioral: In-patient alcohol use disorder treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity tracker adherence
Days (percentage) in which activity tracker was used (day-time and night-time use)
Measured: 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.
Measured: 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®.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end-of-treatment (4 weeks)
Difficulties in emotion regulation
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.
Measured: 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.
Measured: 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.
Measured: In-treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)
Secondary outcomes (2)
Tobacco use
Self-reported cigarettes per day and carbon monoxide (CO) levels measured by a CO monitor reading.
Measured: In treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)
Delay discounting (impulsive decision making)
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).
Measured: From enrollment to the end-of-treatment (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Apr 2022
- Primary completion1 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alba González-Roz, PhD, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629493
- Sponsor's protocol ID
- SV-PA-21-AYUD/2021/50884(2)
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29661655Purani 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.
PubMed 30368021Brickwood 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.
PubMed 30977740Abrantes 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.
PubMed 28755778
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of Activity Trackers Among Alcohol Users Receiving In-patient Treatment for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06629493
- Acronym / sponsor ID
- SV-PA-21-AYUD/2021/50884(2)
- Keywords
- activity tracker, alcohol use disorder, physical activity, treatment, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol use disorder treatment plus Fitbit Versa 3 | Experimental | Behavioral: Fitbit Versa 3, Behavioral: In-patient alcohol use disorder treatmentParticipants will receive in-patient treatment for alcohol use disorder plus an activity tracker |
| Alcohol use disorder treatment | Active comparator | Behavioral: In-patient alcohol use disorder treatmentParticipants will receive in-patient treatment for alcohol use disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being 18 years old or older.
- Be undergoing inpatient treatment for alcohol use disorder.
Key exclusion criteria (1 listed)
- Finishing the in-treatment before 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Versa 3Fitbit Versa 3 is a commercially available activity tracker | Behavioural | Alcohol use disorder treatment plus Fitbit Versa 3 |
| In-patient alcohol use disorder treatmentIn-patient alcohol use disorder treatment, including group therapy, counseling, and occupational activities | Behavioural | Alcohol use disorder treatment, Alcohol use disorder treatment plus Fitbit Versa 3 |
Primary outcome
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.
2 secondary outcomes
Tobacco use
Time frame: In treatment (4 weeks), from enrollment to the end-of-treatment (4 weeks)
Delay discounting (impulsive decision making)
Time frame: From enrollment to the end-of-treatment (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 29661655Scott 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.
- Background: PubMed 30368021Purani 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.
- Background: PubMed 30977740Brickwood 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.
- Background: PubMed 28755778Abrantes 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.
- Fitbit webpage, where information about the the device used in the trial can be foundLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Versa 3 and In-patient alcohol use disorder treatment in people with Substance-Related Disorders and Alcohol-Related Disorders, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity tracker adherence (time frame: Treatment duration (4 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06629493, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.