Clinical trial NCT03631212: Avatar-led Acceptance and Commitment Therapy Smoking Cessation
Official title: An Avatar-led Acceptance and Commitment Therapy Intervention Promotes Smoking Cessation in Young Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: virtual humans
smoking cessation
youth
digital intervention
Acceptance and Commitment Therapy
Lead sponsor: University of Cyprus
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between flexiquit and a wait-list control group
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Regular smoker (at least 1 cigarette per day)
* Parental consent for those under 18years of age

Exclusion Criteria:

* Currently enrolled in another smoking cessation program

Primary outcomes:
measure: Quit rate
timeFrame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
measure: Change in Number of cigarettes
timeFrame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Secondary outcomes:
measure: Change in Nicotine Dependence
timeFrame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
measure: Change in Readiness to quit
timeFrame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
measure: Change in self-efficacy to not smoke in specific situations
timeFrame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
state: Non-US/Non-Canadian
Study officials:
References: