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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 429 (estimated) |
| Sponsor | University of Santiago de Compostela Academic / other |
| Locations | 1 site (Santiago de Compostela, A Coruña) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06900985 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
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.