Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06900985
NA

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

Sponsor: University of Santiago de Compostela

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

429

Start Date

2025-10

Completion Date

2028-04

Last Updated

2025-04-03

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

8-sessions CBT + App

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.

BEHAVIORAL

4-sessions CBT+App

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

BEHAVIORAL

Smoking cessation App

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

Locations (1)

Smoking Cessation and Addictive Disorders Unit

Santiago de Compostela, A Coruña, Spain