Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App (TREATINTSMOKE)

April 27, 2026 updated by: Ana López Durán, University of Santiago de Compostela

Assessment of a Psychological Treatment for Smoking Cessation Combined With an App According to the Intensity of Therapeutic Contact: Randomized Controlled Trial

This randomized controlled trial intends to examine the efficacy of a smoking cessation intervention with an App according to the intensity of therapeutic contact. Participants will be assigned to one of three groups. The first group will receive eight sessions with trained psychologists alongside access to the App. The second group will receive four sessions with trained psychologists plus App access. The control group will only have access to the App. This study seeks to determine the impact of different levels of therapeutic contact on abstinence outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Smoking remains the leading preventable cause of morbidity and mortality worldwide. It is crucial to implement preventive measures to reduce the likelihood of people starting to smoke but also to make effective smoking cessation treatments available to those who smoke. Psychological interventions have proven to be effective to quit smoking and are considered first-choice interventions, especially for specific populations such as adolescents or pregnant women . The motivation behind this proposal is to improve the effectiveness of smoking cessation treatments based on our clinical and research experience in smoking cessation psychological interventions. Although we have very effective psychological treatments, producing abstinence rates of approximately 70% at the end of the treatment, and 35% at one year of follow-up to continue improving its effectiveness and reduce relapse rates is warranted. Furthermore, technological advances can help increase accessibility to available treatments and motivation to participate in smoking cessation interventions.

The main objective of this proposal is to assess the efficacy of a cognitive-behavioral treatment for smoking cessation with new components (anhedonia and mood management, physical activity, and positive social support) according to the intensity of the therapeutic contact, through a randomized controlled trial. The treatment will be conducted through video call format to make it more accessible. The study will compare three groups that will receive treatments of varying intensity of therapeutic contact: 1) 8 intervention sessions + App (Experimental Group 1, EG1), 2) 4 intervention sessions + App (Experimental Group 2, G2), and 3) no therapeutic contact, App only (control group/CG). Our initial hypothesis is that the higher intensity intervention (EG1) will be more effective than EG2 and CG groups in abstinence outcomes at the end of the intervention and in reducing relapse rates for one year follow-up. The EG2 will be more effective than the CG in abstinence outcomes at the end of the intervention and in reducing relapse rates during one-year follow-up.

Digital treatment delivery formats will be used to increase treatment accessibility: 1) treatment sessions will be conducted through video calls which will remove geographical and time-related barriers. This format will be particularly useful for smokers experiencing barriers to access to treatment due to work/family schedules; 2) a smoking cessation App will be used to improve adherence and access to treatment components anytime, anywhere. Moreover, integrating technology into the treatment can facilitate participants intersessions tasks and support the work of professionals. Our previous experience with an App as a complement to the smoking cessation intervention showed excellent abstinence outcomes.

Study Type

Interventional

Enrollment (Estimated)

429

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ana López-Durán, Phd.
  • Phone Number: +34 881813774
  • Email: ana.lopez@usc.es

Study Locations

  • Spain
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15885
        • Smoking Cessation and Addictive Disorders Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • aged 18 or over
  • wishing to participate in the treatment
  • providing written informed consent
  • smoking at least 5 cigarettes per day
  • completion of all pre-treatment assessment questionnaires
  • having a valid email address
  • having an Android or iOS smartphone and being willing to use it throughout the treatment

Exclusion Criteria:

  • a diagnosis of severe mental disorder (bipolar disorder and/or psychotic disorder)
  • concurrent substance use disorder (alcohol, cannabis, stimulant, hallucinogen and/or opioid)
  • using other tobacco products (electronic cigarette with nicotine, cigars or cigarillos)
  • having completed an effective psychological treatment to quit smoking during the previous year
  • having completed a pharmacological treatment to quit smoking in the last year (any smoking cessation medication approved by the Agencia Española del Medicamento)
  • having a physical pathology involving high vital risk that requires immediate intervention (e.g., recent myocardial infarction)
  • having visual difficulties that prevent the use of the App.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. High-intensity therapeutic contact cognitive-behavioral treatment for smoking cessation with App
It will consist of an App and 8 one-hour sessions applied in group format once a week (8 weeks total duration). The sessions will be conducted by trained clinical psychology/general health psychology professionals and will be carried out using video calls.
Behavioral: 8-sessions CBT + App
It will consist of 8 one-hour sessions applied in group format once a week and participants will be followed at 3, 6, and 12 months. The sessions will be conducted by clinical psychology/general health psychology professionals and will be carried out using video calls. The smoking cessation treatment follows a cognitive-behavioral approach with components for anhedonia reduction, increased physical activity and positive social support, being a modified, multidisciplinary, and extended version of the original smoking cessation program (Becoña, 2007; Becoña et al., 2017). The treatment will be complemented with an App with active therapeutic components that participants will use during treatment and the one-year follow-up period.
Active Comparator: 2. Medium-intensity therapeutic contact CBT for smoking cessation with App
It will consist of an App and 4 one-hour sessions applied in group format every two-weeks (8 weeks total duration). The sessions will be conducted by trained clinical psychology/general health psychology professionals and will be carried out using video calls.
Behavioral: 4-sessions CBT+App
It will consist of 4 one-hour sessions applied in group format every two-weeks (8 weeks total duration) and participants will be followed at 3, 6, and 12 months. The sessions will be conducted by clinical psychology/general health psychology professionals and will be carried out using video calls. The 4 sessions will have the following content: 1) explanation of treatment rationale and components available in the App; 2) participants' progress monitoring, reinforcement of achieved goals, and analysis of difficulties; 3) cessation planning support; and 4) relapse prevention support. The treatment sessions will be protocolized in a treatment manual. The treatment will be complemented with the same App that the other conditions
Active Comparator: 3. App only (no therapeutic-contact group).
It will consist of the same App than participants assigned to Conditions 1 and 2, but without contact with professionals
Behavioral: Smoking cessation App
It will consist in the same App than the other two conditions. No therapeutic contact will be avaliable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-days point prevalence abstinence
Time Frame: At 12-months post-intervention
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
At 12-months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-days point prevalence
Time Frame: At 3 and 6-months post-intervention
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
At 3 and 6-months post-intervention
7-days point prevalence abstinence
Time Frame: At 7-days post-quit day
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
At 7-days post-quit day
Satisfaction with the intervention
Time Frame: At 8-weeks after beginning the intervention
Scores obtained in Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 19979; Spanish version of Vázquez et al., 2017)
At 8-weeks after beginning the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Investigators

  • Principal Investigator: Ana López-Durán, Phd., University of Santiago de Compostela
  • Principal Investigator: Elisardo Becoña Iglesias, Phd., University of Santiago de Compostela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID2023-146663OB-I00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Behaviors

Clinical Trials on 8-sessions CBT + App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe