Smoking CessationFlexiquitNCT03631212
Avatar-led Acceptance and Commitment Therapy Smoking Cessation
A study testing Flexiquit in people with Smoking Cessation, run by University of Cyprus at 1 site in Cyprus.
Trial summary
Smoking remains a global concern, especially for youth where developmentally-suited smoking cessation programs are lacking and especially among those not presenting for treatment on their own. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Flexiquit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Sep 2017to 30 Jul 2020
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Regular smoker (at least 1 cigarette per day)
- Parental consent for those under 18years of age
Who cannot join
- Currently enrolled in another smoking cessation program
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
University of Cyprus
Nicosia, Non-US/Non-Canadian, 1678
Maria Karekla, PhD, 22892100, mkarekla@ucy.ac.cy
About this study
Official title: An Avatar-led Acceptance and Commitment Therapy Intervention Promotes Smoking Cessation in Young Adults
Smoking remains a global concern, especially for youth where developmentally-suited smoking cessation programs are lacking and especially among those not presenting for treatment on their own. We aimed to assess the effectiveness of an avatar-led digitalized smoking cessation intervention (Flexiquit) based on Acceptance and Commitment Therapy (ACT) for young adult smokers at all levels of motivation to quit.
Read the detailed description
Cigarette smoking is associated with various health problems, particularly certain forms of cancer and early death (Centers for Disease Control and Prevention, 1997). More recently, smoking has become a global problem among youth and it is imperative that research puts an emphasis on prevention and intervention particularly in this age group (World Health Organization, 2009). Over the past few years, research has shown that internet-based interventions are more cost effective, cater to individuals who are unable/unwilling to attend weekly treatment sessions with a therapist, and are promising in terms of improving attrition rates, a major problem with most treatment trials. Moreover, internet-based interventions use technology often utilized to attract youth (interactive games, animation, video clips etc.) and thus may reach and engage a wider range of individuals than traditional face-to-face interventions. ACT is an empirically-based intervention that uses acceptance and mindfulness strategies and has been shown to increase psychological flexibility. The aim of the present study is to investigate the usefulness and effectiveness of an Acceptance and Commitment Therapy (ACT) internet-based smoking cessation intervention program for college, high school and vocational school student smokers. Findings are expected to show that a digitalized program designed to engage youth in smoking cessation can result in quitting smoking and has a high applicability potential especially among the hard-to-reach population of youth.
- Conditions
- Smoking Cessation
- Being tested
- Flexiquit
- Keywords
- virtual humans, smoking cessation, youth, digital intervention, Acceptance and Commitment Therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexiquitBehavioural
Digital avatar-led Acceptance and Commitment Therapy for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control | No intervention | Wait-list control group |
| Flexiquit | Experimental | Digital ACT-based intervention for smoking cessation Receives: Behavioral: Flexiquit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit rate
Change in Smoking quit status at each assessment point
Measured: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Change in Number of cigarettes
Change in the number of cigarettes smoked per day
Measured: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Secondary outcomes (3)
Change in Nicotine Dependence
Change in the Fagerstrom Test of Nicotine Dependence scores
Measured: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Change in Readiness to quit
Change in the Contemplation Ladder assessing stages of change
Measured: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Change in self-efficacy to not smoke in specific situations
Change in Smoking Self-Efficacy Questionnaire scores
Measured: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start15 Sep 2017
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Model description
- Comparison between flexiquit and a wait-list control group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Karekla, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631212
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2013/05
- Acronym
- Flexiquit
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Avatar-led Acceptance and Commitment Therapy Intervention Promotes Smoking Cessation in Young Adults
- ClinicalTrials.gov ID
- NCT03631212
- Acronym / sponsor ID
- Flexiquit / ΕΕΒΚ/ΕΠ/2013/05
- Conditions
- Smoking Cessation
- Keywords
- virtual humans, smoking cessation, youth, digital intervention, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 15 Aug 2018 (actual)
- 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.
Smoking remains a global concern, especially for youth where developmentally-suited smoking cessation programs are lacking and especially among those not presenting for treatment on their own. We aimed to assess the effectiveness of an avatar-led digitalized smoking cessation intervention (Flexiquit) based on Acceptance and Commitment Therapy (ACT) for young adult smokers at all levels of motivation to quit.
Detailed description
Cigarette smoking is associated with various health problems, particularly certain forms of cancer and early death (Centers for Disease Control and Prevention, 1997). More recently, smoking has become a global problem among youth and it is imperative that research puts an emphasis on prevention and intervention particularly in this age group (World Health Organization, 2009). Over the past few years, research has shown that internet-based interventions are more cost effective, cater to individuals who are unable/unwilling to attend weekly treatment sessions with a therapist, and are promising in terms of improving attrition rates, a major problem with most treatment trials. Moreover, internet-based interventions use technology often utilized to attract youth (interactive games, animation, video clips etc.) and thus may reach and engage a wider range of individuals than traditional face-to-face interventions. ACT is an empirically-based intervention that uses acceptance and mindfulness strategies and has been shown to increase psychological flexibility. The aim of the present study is to investigate the usefulness and effectiveness of an Acceptance and Commitment Therapy (ACT) internet-based smoking cessation intervention program for college, high school and vocational school student smokers. Findings are expected to show that a digitalized program designed to engage youth in smoking cessation can result in quitting smoking and has a high applicability potential especially among the hard-to-reach population of youth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between flexiquit and a wait-list control group
| Arm | Type | Receives |
|---|---|---|
| Waitlist control | No intervention | –Wait-list control group |
| Flexiquit | Experimental | Behavioral: FlexiquitDigital ACT-based intervention for smoking cessation |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Regular smoker (at least 1 cigarette per day)
- Parental consent for those under 18years of age
Key exclusion criteria (1 listed)
- Currently enrolled in another smoking cessation program
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 |
|---|---|---|
| FlexiquitDigital avatar-led Acceptance and Commitment Therapy for smoking cessation | Behavioural | Flexiquit |
Primary outcome
Quit rate
Time frame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Change in Smoking quit status at each assessment point
Change in Number of cigarettes
Time frame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Change in the number of cigarettes smoked per day
3 secondary outcomes
Change in Nicotine Dependence
Time frame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Change in Readiness to quit
Time frame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Change in self-efficacy to not smoke in specific situations
Time frame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexiquit in people with Smoking Cessation, run by University of Cyprus at 1 site in Cyprus.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 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 Cyprus. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Karekla, PhD (+35722892100, mkarekla@ucy.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit rate (time frame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)). 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?
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 21 Aug 2018.