Avatar-led Acceptance and Commitment Therapy Smoking Cessation (Flexiquit)

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.

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Flexiquit

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Non-US/Non-Canadian
    • Nicosia, Non-US/Non-Canadian, Cyprus, 1678
      • Recruiting
      • University of Cyprus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist control; Wait-list control group
Experimental: Flexiquit; Digital ACT-based intervention for smoking cessation	Behavioral: Flexiquit; Digital avatar-led Acceptance and Commitment Therapy for smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Cyprus

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; smoking cessation; digital intervention; youth; virtual humans
• Other Study ID Numbers: ΕΕΒΚ/ΕΠ/2013/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No