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Completed

NCT Number: NCT02901171

The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Leinster, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

ACT group treatment combined with smartphone application

Behavioral

The Acceptance and Commitment Therapy (ACT) group treatment for smoking cessation will be delivered in six weekly 90-min sessions. Smoking cessation will be promoted in each session by targeting core processes of the ACT model including acceptance, cognitive defusion, mindfulness, flexible perspective taking, values clarification and committed action. In addition, participants will receive an ACT-based smartphone application for smoking cessation. The application will foster core processes of the ACT model through daily exercises, tips and tools.

ACT group treatment

Behavioral

Group based Behavioural Support Programme

Behavioral

The Behavioural Support Programme will be facilitated by stop smoking experts and delivered in six weekly 90-min sessions in a group format. During the sessions, advice, support and information on smoking cessation will be given to participants and behavioural techniques will be reviewed.

Primary outcomes

  1. Seven-day point-prevalence abstinence

    Time frame: 6 weeks after beginning treatment

  2. Seven-day point-prevalence abstinence

    Time frame: 6 months after beginning treatment

Secondary outcomes

  1. Positive mental health measured by the Mental Health Continuum-Short Form

    Time frame: 6 weeks after beginning treatment

  2. Positive mental health measured by the Mental Health Continuum-Short Form

    Time frame: 6 months after beginning treatment

  3. Cigarettes per day in non-abstinent participants

    Time frame: 6 weeks after beginning treatment

  4. Cigarettes per day in non-abstinent participants

    Time frame: 6 months after beginning treatment

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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