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

NCT ID: NCT02901171

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-07-31

Brief 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.

Detailed 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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined Treatment

ACT group treatment combined with smartphone application

Group Type: EXPERIMENTAL

ACT group treatment combined with smartphone application

Intervention Type: 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.

Acceptance and Commitment Therapy (ACT)

ACT group treatment

Group Type: ACTIVE_COMPARATOR

ACT group treatment

Intervention Type: BEHAVIORAL

Behavioural Support Programme

Group based Behavioural Support Programme

Group Type: ACTIVE_COMPARATOR

Group based Behavioural Support Programme

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

ACT group treatment

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise McHugh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

University College Dublin

Dublin, Leinster, Ireland

Countries

Ireland

References

Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

Reference Type: DERIVED

PMID: 35420700 (View on PubMed)

Other Identifiers

moconnor

Identifier Type: -

Identifier Source: org_study_id