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

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ClinicalTrials.gov Identifier: NCT03631212
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Karekla, University of Cyprus

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Flexiquit Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison between flexiquit and a wait-list control group
Masking: None (Open Label)
Masking Description: No masking was carried out
Primary Purpose: Treatment
Official Title: An Avatar-led Acceptance and Commitment Therapy Intervention Promotes Smoking Cessation in Young Adults
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 the Fagerstrom Test of Nicotine Dependence scores

  2. 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 the Contemplation Ladder assessing stages of change

  3. 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) ]
    Change in Smoking Self-Efficacy Questionnaire scores



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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631212


Contacts
Contact: Maria Karekla, PhD +35722892100 mkarekla@ucy.ac.cy

Locations
Cyprus
University of Cyprus Recruiting
Nicosia, Non-US/Non-Canadian, Cyprus, 1678
Contact: Maria Karekla, PhD    22892100    mkarekla@ucy.ac.cy   
Sponsors and Collaborators
University of Cyprus

Responsible Party: Maria Karekla, Assistant Professor, University of Cyprus
ClinicalTrials.gov Identifier: NCT03631212     History of Changes
Other Study ID Numbers: ΕΕΒΚ/ΕΠ/2013/05
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria Karekla, University of Cyprus:
virtual humans
smoking cessation
youth
digital intervention
Acceptance and Commitment Therapy