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

Smoking Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901171
• Other study ID #: moconnor
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• ACT group treatment combined with smartphone application
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

• Group based Behavioural Support Programme
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.

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin	Leinster

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seven-day point-prevalence abstinence		6 weeks after beginning treatment
Primary	Seven-day point-prevalence abstinence		6 months after beginning treatment
Secondary	Positive mental health measured by the Mental Health Continuum-Short Form		6 weeks after beginning treatment
Secondary	Positive mental health measured by the Mental Health Continuum-Short Form		6 months after beginning treatment
Secondary	Cigarettes per day in non-abstinent participants		6 weeks after beginning treatment
Secondary	Cigarettes per day in non-abstinent participants		6 months after beginning treatment