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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Santiago de Compostela

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

aged 18 or over

wishing to participate in the treatment

providing written informed consent

smoking at least 5 cigarettes per day

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

  • Smoking cessation App

    Behavioral

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

Treatment groups

429 Participants
are divided into 3 treatment groups
Group A: 1. High-intensity therapeutic contact cognitive-behavioral treatment for smoking cessation with AppActive comparator 1 intervention
Group B: 2. Medium-intensity therapeutic contact CBT for smoking cessation with AppActive comparator 1 intervention
Group C: 3. App only (no therapeutic-contact group).Active comparator 1 intervention

Trial outcomes

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)

Time frame
At 12-months post-intervention

Secondary outcomes

1

7-days point prevalence

The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)

Time frame
At 3 and 6-months post-intervention
2

7-days point prevalence abstinence

The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)

Time frame
At 7-days post-quit day
3

Satisfaction with the intervention

Scores obtained in Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 19979; Spanish version of Vázquez et al., 2017)

Time frame
At 8-weeks after beginning the intervention

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: