Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Therapeutic Contact Intensity for a Smoking Cessation App Intervention

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

Run by University of Santiago de Compostela · NCT06900985 · Data updated 2026-11-12

This trial tests whether more frequent psychologist sessions with an app help people quit smoking.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment429 (estimated)
SponsorUniversity of Santiago de Compostela
Academic / other
Locations1 site (Santiago de Compostela, A Coruña)
StatusRecruiting
StartedSeptember 1, 2026
Main results expectedApril 2028
Study endsApril 2028
Registry record updatedOctober 23, 2026
Trial IDNCT06900985 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 and older who smoke at least five cigarettes per day, have a smartphone, and are willing to participate.

Probably not a fit

Individuals without reliable access to a smartphone or who have certain severe mental health or substance use exclusions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized trial, adults who smoke at least five cigarettes a day are assigned to one of three groups: eight CBT sessions with app access, four CBT sessions with app access, or app access alone. The study uses video calls to deliver cognitive-behavioral therapy focused on mood, activity, and social support, alongside a digital smoking cessation app. The goal is to see if higher therapeutic contact improves abstinence rates at follow-up compared with app use alone. Outcomes will guide how to optimize digital and clinician-assisted smoking cessation approaches.

Why it matters

Potential benefit: If successful, participants may achieve higher abstinence rates with structured psychologist support plus digital tools.

How similar studies have gone: Previous smoking cessation trials using CBT with digital components have shown promise, though results vary by intensity and population.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Smoking Cessation and Addictive Disorders Unit
    Santiago de Compostela, A Coruña, Spain
    Recruiting

Study contacts

  • Principal investigator: Ana López-Durán, Phd. — University of Santiago de Compostela
  • Study coordinator: Ana López-Durán, Phd.
  • Email: ana.lopez@usc.es
  • Phone: +34 881813774

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.