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NCT Number: NCT06900985

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Smoking Cessation and Addictive Disorders Unit

Santiago de Compostela, A Coruña, 15885, Spain

Location contact

Ana Lopez Duran, Phd

CONTACT

[email protected]

+34 881813939

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

8-sessions CBT + App

Behavioral

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.

4-sessions CBT+App

Behavioral

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

Smoking cessation App

Behavioral

It will consist in the same App than the other two conditions. No therapeutic contact will be avaliable.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ana López-Durán, Phd.

CONTACT

[email protected]

+34 881813774

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study title

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

Acronym: TREATINTSMOKE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 28, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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