Clinical trial NCT02901171: The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking cessation
Acceptance and Commitment Therapy
Smartphone
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Failure to the meet inclusion criteria

Primary outcomes:
measure: Seven-day point-prevalence abstinence
timeFrame: 6 weeks after beginning treatment
measure: Seven-day point-prevalence abstinence
timeFrame: 6 months after beginning treatment
Secondary outcomes:
measure: Positive mental health measured by the Mental Health Continuum-Short Form
timeFrame: 6 weeks after beginning treatment
measure: Positive mental health measured by the Mental Health Continuum-Short Form
timeFrame: 6 months after beginning treatment
measure: Cigarettes per day in non-abstinent participants
timeFrame: 6 weeks after beginning treatment
measure: Cigarettes per day in non-abstinent participants
timeFrame: 6 months after beginning treatment
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
state: Leinster
Study officials:
affiliation: University College Dublin
name: Louise McHugh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.