NCT06967636

Brief Summary

We evaluate intensive smoking cessation interventions (GSP) on morbidity and mortality in terms of assessing the impact among quitters and non-quitters with severe mental disorders (SMD)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15,863

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

17 years

First QC Date

May 5, 2025

Last Update Submit

May 5, 2025

Conditions

Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention

Outcome Measures

Primary Outcomes (2)

  • All-cause morbidity

    Days of hospital contact of all causes

    January 2006 to January 2020

  • All-cause mortality

    Death from all causes

    January 2006 to January 2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants \>18 years with a severe mental disorder (SMD) undergoing the GSP in Denmark at local clinics with consent to follow up.

You may qualify if:

  • F20-F29, F30-F39, F60-F69, F10-F16, F18, F19
  • Participation in the GSP in Denmark

You may not qualify if:

  • Dual diagnosis (F00-F99 and a co-occurring substance-use disorder (F10-F16, F18, F19)
  • \< 18 years
  • No consent to follow-up
  • No baseline smoking status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 13, 2025

Study Start

January 1, 2006

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 13, 2025

Record last verified: 2025-05