Flexiquit: Avatar-led Acceptance and Commitment Therapy Smoking Cessation

• Sponsor: University of Cyprus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03631212
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.5
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Comparison between flexiquit and a wait-list control groupComparison 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: Sep 15, 2017
• Anticipated Primary Completion Date: Jul 30, 2019
• Anticipated Study Completion Date: Jul 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Quit rate [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cyprus	Nicosia	Non-US/Non-Canadian	Cyprus	1678

Sponsors and Collaborators

• University of Cyprus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Karekla, Assistant Professor, University of Cyprus
• ClinicalTrials.gov Identifier: NCT03631212
• Other Study ID Numbers: ΕΕΒΚ/ΕΠ/2013/05
• First Posted: Aug 15, 2018
• Last Update Posted: Aug 21, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Assistant Professor, University of Cyprus: virtual humans; smoking cessation; youth; digital intervention; Acceptance and Commitment Therapy

Study Results

No Results Posted as of Aug 21, 2018