Smoking Cessation, Mental Health Disorders, Inequality in Health PreventionNCT06967636
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 of Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention, run by Parker Research Institute.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention
- How many people
- 15,863 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- F20-F29, F30-F39, F60-F69, F10-F16, F18, F19
- Participation in the GSP in Denmark
Who cannot join
- 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
About this study
Official title: The Impact of Successful Quitting Smoking After the Intensive Gold Standard Programme (GSP) on Morbidity and Mortality Among Smokers With Severe Mental Disorders - A Nationwide Cohort Study From the Danish STOPbase
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)
- Medical subject headings
- Smoking Cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause morbidity
Days of hospital contact of all causes
Measured: January 2006 to January 2020
All-cause mortality
Death from all causes
Measured: January 2006 to January 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2006
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking Cessation, Mental Health Disorders, Inequality in Health PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,863 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sine Holst-Albrechtsen, Parker Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967636
- Sponsor's protocol ID
- 2000-54-0013
- Other IDs
- STOPbase, NPR, RCD
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Successful Quitting Smoking After the Intensive Gold Standard Programme (GSP) on Morbidity and Mortality Among Smokers With Severe Mental Disorders - A Nationwide Cohort Study From the Danish STOPbase
- ClinicalTrials.gov ID
- NCT06967636
- Acronym / sponsor ID
- 2000-54-0013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,863 participants (actual)
- Lead sponsor
- Parker Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- F20-F29, F30-F39, F60-F69, F10-F16, F18, F19
- Participation in the GSP in Denmark
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause morbidity
Time frame: January 2006 to January 2020
Days of hospital contact of all causes
All-cause mortality
Time frame: January 2006 to January 2023
Death from all causes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention, run by Parker Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause morbidity (time frame: January 2006 to January 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.