Avatar-led Acceptance and Commitment Therapy Smoking Cess... | NCT03631212

Studies
Avatar-led Acceptance and Commitment Therapy Smoking Cessation

NCT03631212

Sponsor

University of Cyprus

Status

Unknown status

Last Update Posted

Aug 21, 2018Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Smoking Cessation

Interventions

Flexiquit

Countries

Cyprus

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2017Actual

Primary Completion Date

Jul 30, 2019Estimated

Completion Date

Jul 30, 2020Estimated

First Submitted Date

Aug 7, 2018

First Submission Date that Met QC Criteria

Aug 10, 2018

First Posted Date

Aug 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2018

Last Update Posted Date

Aug 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Karekla, Assistant Professor, University of CyprusPrincipal Investigator

Lead Sponsor

University of CyprusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Waitlist control	No Intervention	Wait-list control group
Flexiquit	Experimental	Digital ACT-based intervention for smoking cessation	Behavioral: Flexiquit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flexiquit	Behavioral	Digital avatar-led Acceptance and Commitment Therapy for smoking cessation	Flexiquit

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Karekla, PhD	Contact	+35722892100		mkarekla@ucy.ac.cy

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cyprus	Recruiting	Nicosia	Non-US/Non-Canadian	1678	Cyprus

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided