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临床试验/NCT02901171
NCT02901171已完成不适用

The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation: a Randomised Controlled Trial Investigating Its Efficacy, Mediators and Moderators

University College Dublin1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Seven-day point-prevalence abstinence

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of a smartphone application in enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study also aims to elucidate the processes through which the treatment promotes smoking cessation and for whom it is most effective.

详细描述

Smoking is the single biggest preventable cause of death in Ireland and costs the exchequer approximately €1-2 billion per annum. Currently, 19.2% of Irish people aged 15 and over smoke. Given the magnitude of human suffering and economic cost associated with smoking, the systematic empirical development of cost-effective smoking cessation interventions is a major public health need. Combining a group-based treatment for smoking cessation with a theoretically-consistent smartphone application has the advantage of augmenting therapeutic content delivered in the clinic with on-the-spot assistance in the individual's natural environment. In accordance, this study will evaluate the efficacy of a smartphone application in enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study will also elucidate the processes through which the treatment promotes smoking cessation. Identifying such mediators of change can inform the enhancement of subsequent interventions, enabling them to retain efficacious elements and disregard redundant elements. Furthermore, this study will identify the participant characteristics associated with differential response to the treatment. Clarifying such treatment moderators can facilitate practitioners in selecting optimal treatments for individual service users.

Participants will attend a baseline assessment on an individual basis prior to their smoking cessation attempt. During this session, participants will provide a breath sample and complete a series of self-report measures: Fagerström Test of Nicotine Dependence, Commitment to Quitting Scale, smoking-related variables (e.g., years smoking, previous quit attempts, etc.), Avoidance and Inflexibility Scale, Mental Health Continuum-Short Form, Valuing Questionnaire, Present Moment Awareness Subscale of the Philadelphia Mindfulness Scale, and the Cognitive Fusion Questionnaire. Participants will then be randomly allocated to the combined treatment, ACT group treatment or group based Behavioural Support Programme. A post-treatment assessment will be conducted to investigate changes in the variables measured at baseline. In addition, a six-month follow-up assessment will determine whether the effects of the treatments are sustained over an extended period of time.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Interested in quitting smoking in the next 30 days
  • Smoking 10 or more cigarettes per day for at least the past 12 months
  • Daily access to a smartphone that is compatible with applications from iTunes (iPhone) or Google Play (Android)

排除标准

  • Currently participating in another smoking cessation intervention
  • Failure to the meet inclusion criteria

研究组 & 干预措施

Combined Treatment

Experimental

ACT group treatment combined with smartphone application

干预措施: ACT group treatment combined with smartphone application (Behavioral)

Acceptance and Commitment Therapy (ACT)

Active Comparator

ACT group treatment

干预措施: ACT group treatment (Behavioral)

Behavioural Support Programme

Active Comparator

Group based Behavioural Support Programme

干预措施: Group based Behavioural Support Programme (Behavioral)

结局指标

主要结局

Seven-day point-prevalence abstinence

时间窗: 6 months after beginning treatment

次要结局

  • Positive mental health measured by the Mental Health Continuum-Short Form(6 months after beginning treatment)
  • Cigarettes per day in non-abstinent participants(6 months after beginning treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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