NCT04765813

Brief Summary

This randomized controlled clinical trial examines the effectiveness of a face-to-face\* cognitive-behavioral behavioral treatment to quit smoking enriched with an App. This project aims to innovate in the psychological smoking cessation treatment and increase abstinence rates in the short and long term. \* Due to the COVID-19 the face-to-face treatment will be conducted in an online format.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

February 16, 2021

Last Update Submit

November 28, 2023

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • Point-prevalence abstinence

    Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥7 days at the end of treatment (week 8 since beginning treatment), and prior to follow-up day at 3-, 6-, and 12-months follow-up.

    1 year

Secondary Outcomes (2)

  • Continuous abstinence

    1 year

  • Reduction of cigarette consumption (cigarettes per day)

    1 year

Study Arms (2)

CBT and active smartphone mobile application

EXPERIMENTAL

Participants receive a cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components

Behavioral: Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components

CBT and control smartphone mobile application

ACTIVE COMPARATOR

Participants receive a cognitive-behavioral treatment to quit smoking along with a control App

Behavioral: Cognitive-behavioral treatment to quit smoking along with a control App

Interventions

Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic componentsBEHAVIORAL

Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs). Participants will use a smartphone App with therapeutic components during the intervention (8 weeks) and follow-up period (time frame: one year).

CBT and active smartphone mobile application
Cognitive-behavioral treatment to quit smoking along with a control AppBEHAVIORAL

Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs). Participants will use a control smartphone App (only to access session materials) during the intervention period (8 weeks).

CBT and control smartphone mobile application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older who smoke at least 8 cigarettes per day
  • Desire to participate voluntarily in the treatment offered to quit smoking
  • Correctly fill out all the pretreatment assessment questionnaires
  • Be able to provide written informed consent
  • Currently own a valid email and a smartphone Android or iOS and willing to use it during treatment

You may not qualify if:

  • To have a diagnosis of a severe mental disorder (bipolar disorder and/or psychotic disorder)
  • To have a substance use disorder (alcohol, cannabis, cocaine, heroin), different from a tobacco use disorder
  • To smoke rolling snuff, cigars, little cigars, or other tobacco products
  • To have participated in an effective psychological treatment to quit smoking during the previous 12 months
  • To have received other effective pharmacological treatment to quit smoking in the previous 12 months (nicotine gum or patches, bupropion, varenicline)
  • To have a physical pathology involving life-threatening risks for the person who would require immediate intervention in individual format (e.g., recent myocardial infarction, pneumothorax)
  • To have a visual impairment that impedes the use of the App

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smoking Cessation and Addictive Disorders Unit, Faculty of Psychology, University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (2)

  • Lopez-Duran A, Becona E, Senra C, Suarez-Castro D, Barroso-Hurtado M, Martinez-Vispo C. A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted with an App: Study Protocol. Int J Environ Res Public Health. 2022 Aug 8;19(15):9770. doi: 10.3390/ijerph19159770.

    PMID: 35955123BACKGROUND

  • Lopez-Duran A, Martinez-Vispo C, Barroso-Hurtado M, Suarez-Castro D, Becona E. Incorporating technology in smoking cessation interventions: In-person vs. Video-call formats. Int J Med Inform. 2025 Mar;195:105774. doi: 10.1016/j.ijmedinf.2024.105774. Epub 2024 Dec 24.

    PMID: 39742855DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elisardo Becoña, PhD

    University of Santiago de Compostela

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology at the Faculty of Psychology

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 21, 2021

Study Start

September 15, 2021

Primary Completion

November 10, 2023

Study Completion

November 10, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)