Assessment of a Psychological Treatment for Smoking Cessation Combined With an App According to the Intensity of Therapeutic Contact: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 429
- 试验地点
- 2
- 主要终点
- 7-days point prevalence abstinence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
1. High-intensity therapeutic contact cognitive-behavioral treatment for smoking cessation with App
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.
干预措施: 8-sessions CBT + App (Behavioral)
2. Medium-intensity therapeutic contact CBT for smoking cessation with App
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.
干预措施: 4-sessions CBT+App (Behavioral)
3. App only (no therapeutic-contact group).
It will consist of the same App than participants assigned to Conditions 1 and 2, but without contact with professionals
干预措施: Smoking cessation App (Behavioral)
结局指标
主要结局
7-days point prevalence abstinence
时间窗: At 12-months post-intervention
The abstinent status will be defined as not having smoked in the last 7 days (not even a puff)
次要结局
- 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)
研究者
Ana López Durán
Phd in Clinical Psychology and Psychobiology/Associated Professor
University of Santiago de Compostela