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

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ClinicalTrials.gov Identifier: NCT02901171
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
University College Dublin

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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: ACT group treatment combined with smartphone application Behavioral: ACT group treatment Behavioral: Group based Behavioural Support Programme Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined Treatment
ACT group treatment combined with smartphone application
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.

Active Comparator: Acceptance and Commitment Therapy (ACT)
ACT group treatment
Behavioral: ACT group treatment
Active Comparator: Behavioural Support Programme
Group based Behavioural Support Programme
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901171


Locations
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Ireland
University College Dublin
Dublin, Leinster, Ireland
Sponsors and Collaborators
University College Dublin
Investigators
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Principal Investigator: Louise McHugh, Ph.D. University College Dublin

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Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT02901171     History of Changes
Other Study ID Numbers: moconnor
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Keywords provided by University College Dublin:
Smoking cessation
Acceptance and Commitment Therapy
Smartphone