Avatar-led Acceptance and Commitment Therapy Smoking Cessation

Smoking Cessation Clinical Trial

— Flexiquit  

Official title:

An Avatar-led Acceptance and Commitment Therapy Intervention Promotes Smoking Cessation in Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03631212
• Other study ID #: ????/??/2013/05
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2018
• Source: University of Cyprus
• Contact: Maria Karekla, PhD
• Phone: +35722892100
• Email: mkarekla[@]ucy.ac.cy
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Flexiquit
Digital avatar-led Acceptance and Commitment Therapy for smoking cessation

Locations

Country	Name	City	State
Cyprus	University of Cyprus	Nicosia	Non-US/Non-Canadian

Sponsors (1)

Lead Sponsor	Collaborator
University of Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit rate	Change in Smoking quit status at each assessment point	Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Primary	Change in Number of cigarettes	Change in the number of cigarettes smoked per day	Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Secondary	Change in Nicotine Dependence	Change in the Fagerstrom Test of Nicotine Dependence scores	Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Secondary	Change in Readiness to quit	Change in the Contemplation Ladder assessing stages of change	Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)
Secondary	Change in self-efficacy to not smoke in specific situations	Change in Smoking Self-Efficacy Questionnaire scores	Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)