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Trial record 84 of 2048 for:    Smoking Cessation

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

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE September 15, 2017
Estimated Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Quit rate [ Time Frame: Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention) ]
    Smoking quit status at each assessment point
  • 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
Change History Complete list of historical versions of study NCT03631212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Avatar-led Acceptance and Commitment Therapy Smoking Cessation
Official Title  ICMJE An Avatar-led Acceptance and Commitment Therapy Intervention Promotes Smoking Cessation in Young Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Behavioral: Flexiquit
Digital avatar-led Acceptance and Commitment Therapy for smoking cessation
Study Arms  ICMJE
  • No Intervention: Waitlist control
    Wait-list control group
  • Experimental: Flexiquit
    Digital ACT-based intervention for smoking cessation
    Intervention: Behavioral: Flexiquit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Maria Karekla, PhD +35722892100 mkarekla@ucy.ac.cy
Listed Location Countries  ICMJE Cyprus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03631212
Other Study ID Numbers  ICMJE ΕΕΒΚ/ΕΠ/2013/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maria Karekla, University of Cyprus
Study Sponsor  ICMJE University of Cyprus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Cyprus
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP