Tobacco Use CessationNCT06629467
Cognitive Behavioral Treatment With Activity Trackers for Smoking Cessation
A study testing Cognitive-behavioral therapy for smoking cessation, Personalized PA plan and Fitbit Versa 3 in people with Tobacco Use Cessation and Physical Activity, run by University of Oviedo at 1 site in Spain.
Trial summary
Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority Worldwide. It is also known that practicing physical activity (PA) may help with smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Physical Activity
- What is being tested?
- Cognitive-behavioral therapy for smoking cessation, Personalized PA plan and Fitbit Versa 3
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2023to 1 Dec 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 aged 18 or over.
- Smoking at least 10 cigarettes per day.
Who cannot join
- Being currently receiving other psychological or pharmacological treatment for smoking cessation.
- Being diagnosed with substance use disorder or severe psychiatric disorder.
- Active suicidal ideation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical Unit of Addictive Behaviors
Oviedo, Principality of Asturias, 33003
About this study
Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority Worldwide. It is also known that practicing physical activity (PA) may help with smoking cessation. Physical activity trackers (PATs) have been demonstrated to increase PA levels among various populations, as a sole intervention or in combination with behavioral interventions targeting PA.
This study aims to examine the feasibility and effect of a cognitive-behavioral therapy (CBT) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation.
Read more
In this study, an estimated sample of 120 adult smokers of at least 10 cigarettes per day will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + PAT; 2) CBT for smoking cessation.
Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + PAT and CBT for smoking cessation in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity), physiological outcomes (i.e. sleep quality, quality of life) and mental health outcomes (anxiety and depression symptoms, difficulties in emotional regulation); 3) to examine the association between PA levels and study outcomes
Read the detailed description
PATs provide information on several objective data related to PA and sleep habits, amongst others. Incipient research has piloted its use for vulnerable populations (e.g., mental health disorders, cancer patients), obtaining satisfactory effects on both feasibility and effectiveness outcomes. In the field of substance use, some studies looked at the effects of PATs on PA but did not evaluate them in a randomized clinical trial. Moreover, increases in PA and improvements in emotional variables may be associated with smoking abstinence, and, arguably, using PAT devices may have an indirect impact on smoking abstinence via these variables.
A 6-week protocol will be employed, including group-based cognitive behavioral therapy for smoking cessation treatment and PAT use. Participants will be recruited from the community and will be randomly allocated to the following conditions: 1) CBT for smoking cessation + PATs; 2) CBT for smoking cessation
A priori power analysis was conducted using Monte Carlo methods to estimate the statistical power of the generalized estimating equations (GEE) models used to analyze seven-day point-prevalence abstinence rates. Assessment point and treatment condition were included as fixed factors, and age was included as a covariate. Additional subject-level variability was incorporated to approximate within-subject correlation across repeated measurements. Under assumptions of a large effect size for time (approximately OR = 2.0), statistical power reached approximately 0.68 for a sample size of 120 participants, indicating moderate sensitivity to detect longitudinal changes in abstinence outcomes. In the case of PA (i.e., steps per day), a Monte Carlo simulation was conducted for a mixed linear model (MLM) including time and group as fixed effects. Age and baseline PA levels were included as covariates. Power exceeded 0.90 even at sample sizes of approximately 30 participants, so the design is fully powered. R 4.5.3 was used for the power analysis.
Analyses will be conducted using the Statistical Package for the Social Sciences (SPSS), R, JASP, and JAMOVI. A set of univariate (i.e., descriptive statistics and frequencies) and multivariate analyses (i.e., t-tests, GEE, and MLM)
- Conditions
- Tobacco Use Cessation, Physical Activity
- Being tested
- Cognitive-behavioral therapy for smoking cessation, Personalized PA plan, Fitbit Versa 3
- Keywords
- Tobacco, Physical activity, Activity tracker, Cognitive-behavioral therapy
- Medical subject headings
- Tobacco Use Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy for smoking cessationBehavioural
Treatment components will include psychoeducation on the consequences of tobacco use and the benefits of quitting; therapeutic commitment; self-monitoring of cigarette smoking; brief advice on healthy eating behaviors and sleep hygiene, physiological feedback (based on CO levels), training in self-control strategies, stimulus control, management of craving with alternative activities, diaphragmatic breathing, weekly personalized physical activity objectives, and relapse prevention strategies. The protocol consists of a nicotine fading procedure, which consists of a weekly reduction in nicotine intake of 30% (based on both tobacco brands and the number of cigarettes) from the first to the fifth session.
Personalized PA planBehavioural
The treatment provider will fix an objective (e.g. go for brisk walking for 30 minutes 3 times this week) for each participant every week according to his/her current PA level, time availability, likes, and fitness level.
Fitbit Versa 3Device
Wearable activity tracker with the functionalities of a watch function, including time, date, calendar, and weather (connection to the internet is required). Physical activity monitoring (steps per day, active minutes per day, plants climbed, heart rate monitoring, time, intensity, caloric expenditure, and exercise type of exercise session), sleep monitoring (sleep time, sleep phases time, sleep quality), stress levels managing and guided breathing application are the main health-related functionalities.
| Study group | Role | What they receive |
|---|---|---|
| 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®. | Experimental | The intervention will be delivered in groups (maximum 4 participants) for a total of 6 weeks. Sessions (1.5 hours) will take place once per week. Personalized PA objectives will be set during the treatment.
Participants in this arm will wear the Fitbit Versa 3® during the treatment (6 weeks). Receives: Behavioral: Cognitive-behavioral therapy for smoking cessation; Behavioral: Personalized PA plan; Device: Fitbit Versa 3 |
| 2) CBT for smoking cessation + personalized PA plan | Active comparator | This intervention include the same components as described above. The exception will be that participants will not be requested to wear the Fitbit Versa 3®. Receives: Behavioral: Cognitive-behavioral therapy for smoking cessation; Behavioral: Personalized PA plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the activity tracker
Acceptability of the activity tracker is measured using the Participant Experience Questionnaire (PEQ) at the end of treatment. This scale ranges from 10 to 50. A higher score means higher acceptability.
Measured: End-of-treatment (6-weeks)
Tobacco use
This variable is operationalized as changes in cigarettes/day, carbon monoxide (CO) changes, and self-reported and verified abstinence (i.e., ≤4 ppm).
Measured: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Feasibility of treatment and activity tracker use
Feasibility is operationalized as treatment completion, attendance to sessions and adherence to Fitbit Versa 3 use.
Measured: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Physical activity
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, from enrollment to end-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Activity tracker perceived utility
Perceived utility with the activity tracker is measured using dichotomous (yes/no) ad-hoc; questions about the utility of the activity tracker for smoking cessation, increasing physical activity, and improving sleep quality.
Measured: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Secondary outcomes (9)
Anxiety symptoms
Anxiety symptoms are 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 End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Depression symptoms
Depression symptoms are 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 End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Hypothetical demand for cigarettes
CPT (Cigarette purchase task) (Items: Maximum number of cigarettes smoked per day, maximum expenditure in cigarettes per day and maximum expenditure per pack)
Measured: Enrollment
Emotional dysregulation of negative valence emotions
Emotional dysregulation of negative emotions is measured with the Difficulties in emotion regulation scale-16 (DERS-16). This scale ranges from 16 to 80 points. A higher score means more difficulties in emotion regulation of negative valence emotions.
Measured: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Emotional dysregulation of positive valence emotions
Emotional dysregulation of positive emotions is measured with Difficulties in Emotion Regulation Scale-Positive (DERS-P). This scale ranges from 13 to 65. A higher score means more difficulties in emotion regulation of positive valence emotions.
Measured: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Delay Discounting
Single and cross-commodity computerized Delay Discounting task of money and tobacco (delay of one day, one week, one month and six month time)
Measured: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Suicide ideation
This variable is measured with the Paykel suicide ideation scale (PSS). This scale ranges from 0 to 5 points. Higher punctuation means more severe suicide ideation.
Measured: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Life Quality
This variable is measured with the European quality of life- 5 dimensions- 5 levels (EQ-5D-5L). This scale ranges from 5 to 25. A higher score means less life quality (more health-related problems).
Measured: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Sleep quality
This variable is measured using The Pittsburgh Sleep Quality Index (PSQI). This scale 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 (6 weeks), from Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
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 start10 May 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 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 Tobacco Use CessationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 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
- NCT06629467
- Sponsor's protocol ID
- SV-PA-21-AYUD/2021/50884.
- Status last verified
- Oct 2024
- First submitted
- 29 Jul 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abrantes AM, Van Noppen D, Bailey G, Uebelacker LA, Buman M, Stein MD. A Feasibility Study of a Peer-Facilitated Physical Activity Intervention in Methadone Maintenance. Ment Health Phys Act. 2021 Oct;21:100419. doi: 10.1016/j.mhpa.2021.100419. Epub 2021 Aug 14.
PubMed 34552664Carreiro S, Chintha KK, Shrestha S, Chapman B, Smelson D, Indic P. Wearable sensor-based detection of stress and craving in patients during treatment for substance use disorder: A mixed methods pilot study. Drug Alcohol Depend. 2020 Apr 1;209:107929. doi: 10.1016/j.drugalcdep.2020.107929. Epub 2020 Mar 3.
PubMed 32193048Goldfine C, Lai JT, Lucey E, Newcomb M, Carreiro S. Wearable and Wireless mHealth Technologies for Substance Use Disorder. Curr Addict Rep. 2020 Sep;7(3):291-300. doi: 10.1007/s40429-020-00318-8. Epub 2020 Jun 11.
PubMed 33738178Purani 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 30368021
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Treatment With Activity Trackers for Smoking Cessation
- ClinicalTrials.gov ID
- NCT06629467
- Acronym / sponsor ID
- SV-PA-21-AYUD/2021/50884.
- Conditions
- Tobacco Use Cessation, Physical Activity
- Keywords
- Tobacco, Physical activity, Activity tracker, Cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 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.
Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority Worldwide. It is also known that practicing physical activity (PA) may help with smoking cessation. Physical activity trackers (PATs) have been demonstrated to increase PA levels among various populations, as a sole intervention or in combination with behavioral interventions targeting PA.
This study aims to examine the feasibility and effect of a cognitive-behavioral therapy (CBT) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation.
In this study, an estimated sample of 120 adult smokers of at least 10 cigarettes per day will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + PAT; 2) CBT for smoking cessation.
Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + PAT and CBT for smoking cessation in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity), physiological outcomes (i.e. sleep quality, quality of life) and mental health outcomes (anxiety and depression symptoms, difficulties in emotional regulation); 3) to examine the association between PA levels and study outcomes
Detailed description
PATs provide information on several objective data related to PA and sleep habits, amongst others. Incipient research has piloted its use for vulnerable populations (e.g., mental health disorders, cancer patients), obtaining satisfactory effects on both feasibility and effectiveness outcomes. In the field of substance use, some studies looked at the effects of PATs on PA but did not evaluate them in a randomized clinical trial. Moreover, increases in PA and improvements in emotional variables may be associated with smoking abstinence, and, arguably, using PAT devices may have an indirect impact on smoking abstinence via these variables.
A 6-week protocol will be employed, including group-based cognitive behavioral therapy for smoking cessation treatment and PAT use. Participants will be recruited from the community and will be randomly allocated to the following conditions: 1) CBT for smoking cessation + PATs; 2) CBT for smoking cessation
A priori power analysis was conducted using Monte Carlo methods to estimate the statistical power of the generalized estimating equations (GEE) models used to analyze seven-day point-prevalence abstinence rates. Assessment point and treatment condition were included as fixed factors, and age was included as a covariate. Additional subject-level variability was incorporated to approximate within-subject correlation across repeated measurements. Under assumptions of a large effect size for time (approximately OR = 2.0), statistical power reached approximately 0.68 for a sample size of 120 participants, indicating moderate sensitivity to detect longitudinal changes in abstinence outcomes. In the case of PA (i.e., steps per day), a Monte Carlo simulation was conducted for a mixed linear model (MLM) including time and group as fixed effects. Age and baseline PA levels were included as covariates. Power exceeded 0.90 even at sample sizes of approximately 30 participants, so the design is fully powered. R 4.5.3 was used for the power analysis.
Analyses will be conducted using the Statistical Package for the Social Sciences (SPSS), R, JASP, and JAMOVI. A set of univariate (i.e., descriptive statistics and frequencies) and multivariate analyses (i.e., t-tests, GEE, and MLM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®. | Experimental | Behavioral: Cognitive-behavioral therapy for smoking cessation, Behavioral: Personalized PA plan, Device: Fitbit Versa 3The intervention will be delivered in groups (maximum 4 participants) for a total of 6 weeks. Sessions (1.5 hours) will take place once per week. Personalized PA objectives will be set during the treatment. Participants in this arm will wear the Fitbit Versa 3® during the treatment (6 weeks). |
| 2) CBT for smoking cessation + personalized PA plan | Active comparator | Behavioral: Cognitive-behavioral therapy for smoking cessation, Behavioral: Personalized PA planThis intervention include the same components as described above. The exception will be that participants will not be requested to wear the Fitbit Versa 3®. |
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 aged 18 or over.
- Smoking at least 10 cigarettes per day.
Key exclusion criteria (3 listed)
- Being currently receiving other psychological or pharmacological treatment for smoking cessation.
- Being diagnosed with substance use disorder or severe psychiatric disorder.
- Active suicidal ideation.
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 |
|---|---|---|
| Cognitive-behavioral therapy for smoking cessationTreatment components will include psychoeducation on the consequences of tobacco use and the benefits of quitting; therapeutic commitment; self-monitoring of cigarette smoking; brief advice on healthy eating behaviors and sleep hygiene, physiological feedback (based on CO levels), training in self-control strategies, stimulus control, management of craving with alternative activities, diaphragmatic breathing, weekly personalized physical activity objectives, and relapse prevention strategies. The protocol consists of a nicotine fading procedure, which consists of a weekly reduction in nicotine intake of 30% (based on both tobacco brands and the number of cigarettes) from the first to the fifth session. | Behavioural | 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®., 2) CBT for smoking cessation + personalized PA plan |
| Personalized PA planThe treatment provider will fix an objective (e.g. go for brisk walking for 30 minutes 3 times this week) for each participant every week according to his/her current PA level, time availability, likes, and fitness level. | Behavioural | 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®., 2) CBT for smoking cessation + personalized PA plan |
| Fitbit Versa 3Wearable activity tracker with the functionalities of a watch function, including time, date, calendar, and weather (connection to the internet is required). Physical activity monitoring (steps per day, active minutes per day, plants climbed, heart rate monitoring, time, intensity, caloric expenditure, and exercise type of exercise session), sleep monitoring (sleep time, sleep phases time, sleep quality), stress levels managing and guided breathing application are the main health-related functionalities. | Device | 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®. |
Primary outcome
Acceptability of the activity tracker
Time frame: End-of-treatment (6-weeks)
Acceptability of the activity tracker is measured using the Participant Experience Questionnaire (PEQ) at the end of treatment. This scale ranges from 10 to 50. A higher score means higher acceptability.
Tobacco use
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
This variable is operationalized as changes in cigarettes/day, carbon monoxide (CO) changes, and self-reported and verified abstinence (i.e., ≤4 ppm).
Feasibility of treatment and activity tracker use
Time frame: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Feasibility is operationalized as treatment completion, attendance to sessions and adherence to Fitbit Versa 3 use.
Physical activity
Time frame: In-treatment, from enrollment to end-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
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®.
Activity tracker perceived utility
Time frame: End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Perceived utility with the activity tracker is measured using dichotomous (yes/no) ad-hoc; questions about the utility of the activity tracker for smoking cessation, increasing physical activity, and improving sleep quality.
9 secondary outcomes
Anxiety symptoms
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Depression symptoms
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Hypothetical demand for cigarettes
Time frame: Enrollment
Emotional dysregulation of negative valence emotions
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Emotional dysregulation of positive valence emotions
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Delay Discounting
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Suicide ideation
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Life Quality
Time frame: From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
Sleep quality
Time frame: In treatment (6 weeks), from Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.
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 22 Jul 2026.
- Background: PubMed 34552664Abrantes AM, Van Noppen D, Bailey G, Uebelacker LA, Buman M, Stein MD. A Feasibility Study of a Peer-Facilitated Physical Activity Intervention in Methadone Maintenance. Ment Health Phys Act. 2021 Oct;21:100419. doi: 10.1016/j.mhpa.2021.100419. Epub 2021 Aug 14.
- Background: PubMed 32193048Carreiro S, Chintha KK, Shrestha S, Chapman B, Smelson D, Indic P. Wearable sensor-based detection of stress and craving in patients during treatment for substance use disorder: A mixed methods pilot study. Drug Alcohol Depend. 2020 Apr 1;209:107929. doi: 10.1016/j.drugalcdep.2020.107929. Epub 2020 Mar 3.
- Background: PubMed 33738178Goldfine C, Lai JT, Lucey E, Newcomb M, Carreiro S. Wearable and Wireless mHealth Technologies for Substance Use Disorder. Curr Addict Rep. 2020 Sep;7(3):291-300. doi: 10.1007/s40429-020-00318-8. Epub 2020 Jun 11.
- 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.
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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 Cognitive-behavioral therapy for smoking cessation, Personalized PA plan and Fitbit Versa 3 in people with Tobacco Use Cessation and Physical Activity, 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 3 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 22 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?
Acceptability of the activity tracker (time frame: End-of-treatment (6-weeks)). The study lists 5 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 NCT06629467, 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 22 Jul 2026.