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CompletedNCT06967636Updated May 13, 2025

The Impact of Successful Quitting Smoking After Intensive Smoking Cessation Interventions on Morbidity and Mortality Among Smokers With Severe Mental Disorders - A Nationwide Cohort Study From the Danish Smoking Cessation Database

An observational study in Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention, sponsored by Parker Research Institute. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Parker Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15,863
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention

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03

In context

Smoking Cessation

350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.

This study's enrollment of 15,863 is above the median of 211 across 20 observational studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

Parker Research Institute is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15,863 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. All-cause morbidity

    Days of hospital contact of all causes

    Time frame: January 2006 to January 2020

  2. All-cause mortality

    Death from all causes

    Time frame: January 2006 to January 2023

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06967636
Lead sponsor
Parker Research Institute
Responsible party
Sine Holst-Albrechtsen (MD, MSc, Parker Research Institute) — Principal investigator
First posted
May 13, 2025
Start date
Jan 1, 2006
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
May 13, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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