Clinical trial NCT06900985: Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
Official title: Assessment of a Psychological Treatment for Smoking Cessation Combined With an App According to the Intensity of Therapeutic Contact: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Behaviors
Keywords: smoking
treatment
cognitive-behavioral
therapeutic-contact intensity
digital intervention
eHealth
randomized controlled trial
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 7-days point prevalence abstinence
timeFrame: At 12-months post-intervention
Secondary outcomes:
measure: 7-days point prevalence
timeFrame: At 3 and 6-months post-intervention
measure: 7-days point prevalence abstinence
timeFrame: At 7-days post-quit day
measure: Satisfaction with the intervention
timeFrame: At 8-weeks after beginning the intervention
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Smoking Cessation and Addictive Disorders Unit
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Ana López-Durán, Phd.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Santiago de Compostela
name: Elisardo Becoña Iglesias, Phd.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.