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

NCT06900985 | Not Yet Recruiting

• 1 other identifier: PID2023-146663OB-I00
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Behaviors

Keywords

smoking; treatment; cognitive-behavioral; therapeutic-contact intensity; digital intervention; eHealth; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 7-days point prevalence abstinence

  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 Outcomes (3)

• 7-days point prevalence

  At 3 and 6-months post-intervention

• 7-days point prevalence abstinence

  At 7-days post-quit day

• Satisfaction with the intervention

  At 8-weeks after beginning the intervention

Study Arms (3)

1. High-intensity therapeutic contact cognitive-behavioral treatment for smoking cessation with App

ACTIVE COMPARATOR

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

2. Medium-intensity therapeutic contact CBT for smoking cessation with App

ACTIVE COMPARATOR

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

3. App only (no therapeutic-contact group).

ACTIVE COMPARATOR

It will consist of the same App than participants assigned to Conditions 1 and 2, but without contact with professionals

Behavioral: Smoking cessation App

Interventions

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.

1. High-intensity therapeutic contact cognitive-behavioral treatment for smoking cessation with App

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

2. Medium-intensity therapeutic contact CBT for smoking cessation with App

Smoking cessation App BEHAVIORAL

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

3. App only (no therapeutic-contact group).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Smoking Cessation and Addictive Disorders Unit

Santiago de Compostela, A Coruña, 15885, Spain

Location

Related Publications (4)

• 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: 39742855 BACKGROUND

• Martinez-Vispo C, Rodriguez-Cano R, Lopez-Duran A, Senra C, Fernandez Del Rio E, Becona E. Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial. PLoS One. 2019 Apr 8;14(4):e0214252. doi: 10.1371/journal.pone.0214252. eCollection 2019.

  PMID: 30958831 BACKGROUND

• Lopez-Duran A, Martinez-Vispo C, Suarez-Castro D, Barroso-Hurtado M, Becona E. The Efficacy of the SinHumo App Combined With a Psychological Treatment to Quit Smoking: A Randomized Clinical Trial. Nicotine Tob Res. 2025 Feb 24;27(3):429-437. doi: 10.1093/ntr/ntae053.

  PMID: 38538080 BACKGROUND

• Patnode CD, Henderson JT, Coppola EL, Melnikow J, Durbin S, Thomas RG. Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 Jan 19;325(3):280-298. doi: 10.1001/jama.2020.23541.

  PMID: 33464342 BACKGROUND

MeSH Terms

Conditions

Smoking

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ana López-Durán, Phd.

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Elisardo Becoña Iglesias, Phd.

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana López-Durán, Phd.

CONTACT

+34 881813774; ana.lopez@usc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd in Clinical Psychology and Psychobiology/Associated Professor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

ES (1)