NCT03631212

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

August 7, 2018

Last Update Submit

August 17, 2018

Conditions

Smoking Cessation

Keywords

virtual humanssmoking cessationyouthdigital interventionAcceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • 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 Readiness to quit

    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

    Post-intervention (following completion of digital session 5) and follow-up (3 months and 6 months after post-intervention)

Study Arms (2)

Waitlist control

NO INTERVENTION

Wait-list control group

Flexiquit

EXPERIMENTAL

Digital ACT-based intervention for smoking cessation

Behavioral: Flexiquit

Interventions

FlexiquitBEHAVIORAL

Digital avatar-led Acceptance and Commitment Therapy for smoking cessation

Flexiquit

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Regular smoker (at least 1 cigarette per day)
  • Parental consent for those under 18years of age

You may not qualify if:

  • Currently enrolled in another smoking cessation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cyprus

Nicosia, Non-US/Non-Canadian, 1678, Cyprus

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Maria Karekla, PhD

CONTACT

+35722892100mkarekla@ucy.ac.cy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was carried out
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison between flexiquit and a wait-list control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 15, 2018

Study Start

September 15, 2017

Primary Completion

July 30, 2019

Study Completion

July 30, 2020

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CY(1)