SmokingNCT02901171
The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation
A study testing ACT group treatment combined with smartphone application, ACT group treatment and Group based Behavioural Support Programme in people with Smoking, run by University College Dublin at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- ACT group treatment combined with smartphone application, ACT group treatment and Group based Behavioural Support Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Currently participating in another smoking cessation intervention
- Failure to the meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- ACT group treatment combined with smartphone application, ACT group treatment, Group based Behavioural Support Programme
- Keywords
- Smoking cessation, Acceptance and Commitment Therapy, Smartphone
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT group treatment combined with smartphone applicationBehavioural
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 treatmentBehavioural
Group based Behavioural Support ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Treatment | Experimental | ACT group treatment combined with smartphone application Receives: Behavioral: ACT group treatment combined with smartphone application |
| Acceptance and Commitment Therapy (ACT) | Active comparator | ACT group treatment Receives: Behavioral: ACT group treatment |
| Behavioural Support Programme | Active comparator | Group based Behavioural Support Programme Receives: Behavioral: Group based Behavioural Support Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seven-day point-prevalence abstinence
Measured: 6 weeks after beginning treatment
Seven-day point-prevalence abstinence
Measured: 6 months after beginning treatment
Secondary outcomes (4)
Positive mental health measured by the Mental Health Continuum-Short Form
Measured: 6 weeks after beginning treatment
Positive mental health measured by the Mental Health Continuum-Short Form
Measured: 6 months after beginning treatment
Cigarettes per day in non-abstinent participants
Measured: 6 weeks after beginning treatment
Cigarettes per day in non-abstinent participants
Measured: 6 months after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise McHugh, Ph.D., Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901171
- Sponsor's protocol ID
- moconnor
- Status last verified
- Jul 2018
- First submitted
- 9 Sep 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
Publications
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.
PubMed 35420700
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02901171
- Acronym / sponsor ID
- moconnor
- Conditions
- Smoking
- Keywords
- Smoking cessation, Acceptance and Commitment Therapy, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined Treatment | Experimental | Behavioral: ACT group treatment combined with smartphone applicationACT group treatment combined with smartphone application |
| Acceptance and Commitment Therapy (ACT) | Active comparator | Behavioral: ACT group treatmentACT group treatment |
| Behavioural Support Programme | Active comparator | Behavioral: Group based Behavioural Support ProgrammeGroup based Behavioural Support Programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Currently participating in another smoking cessation intervention
- Failure to the meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT group treatment combined with smartphone applicationThe 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. | Behavioural | Combined Treatment |
| ACT group treatment | Behavioural | Acceptance and Commitment Therapy (ACT) |
| Group based Behavioural Support ProgrammeThe 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. | Behavioural | Behavioural Support Programme |
Primary outcome
Seven-day point-prevalence abstinence
Time frame: 6 weeks after beginning treatment
Seven-day point-prevalence abstinence
Time frame: 6 months after beginning treatment
4 secondary outcomes
Positive mental health measured by the Mental Health Continuum-Short Form
Time frame: 6 weeks after beginning treatment
Positive mental health measured by the Mental Health Continuum-Short Form
Time frame: 6 months after beginning treatment
Cigarettes per day in non-abstinent participants
Time frame: 6 weeks after beginning treatment
Cigarettes per day in non-abstinent participants
Time frame: 6 months after beginning treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Derived from this study: PubMed 35420700Jackson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise McHugh, Ph.D. principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT group treatment combined with smartphone application, ACT group treatment and Group based Behavioural Support Programme in people with Smoking, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seven-day point-prevalence abstinence (time frame: 6 weeks after beginning treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.