NCT06945770

Brief Summary

This study evaluated the effectiveness of an online psycho-education program offered in addition to routine care for individuals attending a smoking cessation clinic. Conducted as a randomized controlled trial, the study assigned 103 participants to the intervention group and 105 to the control group. Based on follow-up data, analyses were carried out with 37 participants from the intervention group and 24 from the control group. Primary Hypotheses Among individuals who applied to the Smoking Cessation Outpatient Clinic at the Institute on Drug Abuse, Toxicology, and Pharmaceutical Science, Ege University, those who receive additional online psychoeducational support integrated into the outpatient service are expected to: H1: Be more successful in quitting smoking compared to those who do not receive this support. H2: Be more successful in reducing the number of cigarettes smoked per day. H3: Show a significant change in their level of nicotine dependence. Secondary Hypotheses H4: Show significant progress in the stages of change regarding smoking behavior. H5: Show significant improvement in their mental well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 11, 2025

Last Update Submit

April 20, 2025

Conditions

Smoking Cessation

Keywords

tobacco use disordersmoking cessationweb-based psycho-education

Outcome Measures

Primary Outcomes (3)

  • the Fagerström Test for Nicotine Dependence (FTND) scores

    Nicotine dependence was assessed using the Fagerström Test for Nicotine Dependence (FTND), a standardized scale ranging from 0 to 10, with higher scores indicating a greater level of nicotine dependence.

    from enrollment to the end of the treatment at 4 weeks

  • number of cigarettes smoked

    number of cigarettes smoked on each day

    from enrollment to the end of the treatment at 4 weeks

  • smoking cessation

    smoking less than 5 cigarettes

    from enrollment to the end of the treatment at 4 weeks

Secondary Outcomes (2)

  • mental well being score

    from enrollment to the end of the treatment at 4 weeks

  • HAPA stage

    from enrollment to the end of the treatment at 4 weeks

Study Arms (2)

POLSIS

EXPERIMENTAL

web based smoking cessation psycho-education

Behavioral: POLSISDrug: routine service delivery(Nicotine Replacement Theraphy, Cytisine)

control

ACTIVE COMPARATOR

routine service delivery

Drug: routine service delivery(Nicotine Replacement Theraphy, Cytisine)

Interventions

POLSISBEHAVIORAL

web based smoking cessation psycho-education

POLSIS
routine service delivery(Nicotine Replacement Theraphy, Cytisine)DRUG

routine smoking cessation service delivery

POLSIScontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • using internet
  • being a volunteer

You may not qualify if:

  • not using internet
  • not being a volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use Disorder

Interventions

cytisine

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • duygu altin, phd

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 25, 2025

Study Start

May 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)