Avatar-led Acceptance and Commitment Therapy Smoking Cessation

Study Overview
=================
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.

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

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Flexiquit


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison between flexiquit and a wait-list control group
Masking: None (Open Label)


Arms and Interventions

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

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
youth, virtual humans, smoking cessation, digital intervention, Acceptance and Commitment Therapy