Cognitive Behavioral Treatment with Activity Trackers for Smoking Cessation

NCT06629467 | Recruiting

• 1 other identifier: SV-PA-21-AYUD/2021/50884.
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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 smoking cessation. Physical activity trackers have been demonstrated to increase PA levels in different studies with various populations, as a sole intervention or in combination with interventions targeting PA. This study aims to examine the feasibility, effect, and cost-effectiveness of cognitive-behavioral therapy (CBT) + Personalized physical activity (PA) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation. Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority worldwide. In this study, an estimated sample of 128 adult smokers will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3®; 2) CBT for smoking cessation + personalized PA plan. Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT protocol for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + personalized PA plan + Fitbit Versa 3® and CBT for smoking cessation + personalized PA plan in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity) and mental health outcomes (anxiety and depression symptoms, emotional dysregulation); 3) to examine the cost-effectiveness of CBT for smoking cessation + personalized PA plan + Fitbit Versa 3® vs. CBT for smoking cessation + personalized PA plan in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity) and mental health outcomes (anxiety and depression symptoms, emotional dysregulation).

Conditions

Tobacco Use Cessation; Physical Activity

Keywords

Tobacco; Physical activity; Activity tracker; Cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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®.

  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.

  End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

Secondary Outcomes (9)

• Anxiety symptoms

  From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

• Depression symptoms

  From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

• Hypothetical demand for cigarettes

  Enrollment

• Emotional dysregulation of negative valence emotions

  From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

• Emotional dysregulation of positive valence emotions

  From Enrollment to End-of-treatment (6-weeks), one-, three-, six-, -month follow-up.

Study Arms (2)

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).

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®.

Behavioral: Cognitive-behavioral therapy for smoking cessation; Behavioral: Personalized PA plan

Interventions

Cognitive-behavioral therapy for smoking cessation BEHAVIORAL

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.

1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.; 2) CBT for smoking cessation + personalized PA plan

Personalized PA plan BEHAVIORAL

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.

1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.; 2) CBT for smoking cessation + personalized PA plan

Fitbit Versa 3 DEVICE

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.

1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3 ®.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being aged 18 or over.
• Smoking at least 10 cigarettes per day.

You may not qualify if:

• Being currently receiving other psychological or pharmacological treatment for smoking cessation.
• Being diagnosed with substance use disorder or severe psychiatric disorder.
• Active suicidal ideation.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Clinical Unit of Addictive Behaviors

Oviedo, Principality of Asturias, 33003, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 34552664 BACKGROUND

• Carreiro 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.

  PMID: 32193048 BACKGROUND

• Goldfine 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.

  PMID: 33738178 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.

  PMID: 30368021 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Cessation; Motor Activity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: October 8, 2024
• Study Start: May 10, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

ES (1)