Severe Mental DisorderNCT03583203
Tobacco Intensive Motivational and Estimate Risk
A study testing personalized information about lung damage in people with Severe Mental Disorder and Smoking Cessation, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Severe Mental Disorder, Smoking Cessation, COPD
- What is being tested?
- personalized information about lung damage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 40 and 70
- Confirmed diagnosis of Bipolar Disorder or Schizophrenia according to Diagnostic and Statistical Manual of Mental Disorder IV (DSM-IV-TR)
- Active smokers who currently consume at least 10 cigarettes a day, with a cumulative consumption of 10 packets/year or more.
Who cannot join
- Previous respiratory diagnosis of: asthma, cystic fibrosis, tuberculosis, simple chronic bronchitis, restrictive pulmonary disease or bronchiectasis
- Acute respiratory symptoms
- Heart disease or advanced oncological processes
- Existence of a pathology which makes it advisable not to perform spirometry (recent pneumothorax, recent thoracic or abdominal surgery, aortic aneurysm, unstable angulation, retinal detachment, facial hemiparesis or oral/dental problems)
- Patients who, due to their intellectual disability or mental pathology, do not understand or cannot be forced to perform spirometry
- Clinical instability with results of over 14 points on the Hamilton Depression Rating Scale (HDRS), a Young Mania Rating Scale (YMRS) of over 6 or a Positive and Negative Syndrome Scale (PANSS) of over 70
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy in Patients With Severe Mental Disorders of an Intensive Motivational Interventional Programme Offering Individualized Information on Respiratory Damage for Smoking Cessation
Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. The main measurement will be having given up smoking in month 12, measurement of self-reported abstinence on the 7 previous days and confirmed by a CO-oximeter test< 10 ppm, between the intervention and control group. A total of 9 urban and rural mental health centres will participate in the study. The intervention group will undergo spirometry and presence and the degree of respiratory obstruction will be assessed. Participants will be given individual information to generate a motivational message about the possibilities of prevention and the information will be maintained for three months by sending text messages (SMS) to their mobile phones. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed
- Conditions
- Severe Mental Disorder, Smoking Cessation, COPD
- Being tested
- personalized information about lung damage
- Keywords
- schizophrenia, bipolar disorder, tobacco, COPD
- Medical subject headings
- Mental Disorders, Smoking Cessation, Pulmonary Disease, Chronic Obstructive, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized information about lung damageDevice
Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group will include personalized information about lung damage. After evaluating their COPD, the patients will be informed about its existence it so and staging. Depending on the damage found, the generation of motivation will focus on the different prevention methods. Likewise, after the motivation level is set, the patients will be offered the option of treatment and regular follow-up. The intervention will be strengthened by motivational messages, half of which are linked to the possibilities of preventing respiratory damage, sent to the patient's mobile phone via SMS during the 3 months after the face-to-face intervention. Patients without mobile phones will receive a call on their phone to convey the same messages. Receives: Device: personalized information about lung damage |
| Control Group | No intervention | The control intervention lasts 30 minutes and will be structured around the 5 A's technique (Ask, Advice, Assess, Assist and Arrange). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Self-reported abstinence over the previous 7 days, confirmed by cooximetry with expired CO <10 ppm
Measured: 12 months
COPD diagnosis
Presence of COPD and staging and percentage of forced expiratory volume at one second (FEV1) compared with expected level
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start12 Jul 2018
- Primary completion1 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Mental DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Fernando Sarramea Crespo, Hospital Universitario Reina Sofia de Cordoba
- Investigators
- Fernando Sarramea Crespo, Phd, Principal investigator, Hospital Universitario Reina Sofia Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583203
- Sponsor's protocol ID
- PI16/0082
- Status last verified
- Jan 2020
- First submitted
- 28 Jun 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jaen-Moreno MJ, Feu N, Redondo-Ecija J, Montiel FJ, Gomez C, Del Pozo GI, Alcala JA, Gutierrez-Rojas L, Balanza-Martinez V, Chauca GM, Carrion L, Osuna MI, Sanchez MD, Caro I, Ayora M, Valdivia F, Lopez MS, Poyato JM, Sarramea F. Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial. Trials. 2019 Jan 14;20(1):47. doi: 10.1186/s13063-018-3139-9.
PubMed 30642365
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy in Patients With Severe Mental Disorders of an Intensive Motivational Interventional Programme Offering Individualized Information on Respiratory Damage for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03583203
- Acronym / sponsor ID
- PI16/0082
- Conditions
- Severe Mental Disorder, Smoking Cessation, COPD
- Keywords
- schizophrenia, bipolar disorder, tobacco, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jul 2018 (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.
Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. The main measurement will be having given up smoking in month 12, measurement of self-reported abstinence on the 7 previous days and confirmed by a CO-oximeter test< 10 ppm, between the intervention and control group. A total of 9 urban and rural mental health centres will participate in the study. The intervention group will undergo spirometry and presence and the degree of respiratory obstruction will be assessed. Participants will be given individual information to generate a motivational message about the possibilities of prevention and the information will be maintained for three months by sending text messages (SMS) to their mobile phones. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: personalized information about lung damageThis group will include personalized information about lung damage. After evaluating their COPD, the patients will be informed about its existence it so and staging. Depending on the damage found, the generation of motivation will focus on the different prevention methods. Likewise, after the motivation level is set, the patients will be offered the option of treatment and regular follow-up. The intervention will be strengthened by motivational messages, half of which are linked to the possibilities of preventing respiratory damage, sent to the patient's mobile phone via SMS during the 3 months after the face-to-face intervention. Patients without mobile phones will receive a call on their phone to convey the same messages. |
| Control Group | No intervention | –The control intervention lasts 30 minutes and will be structured around the 5 A's technique (Ask, Advice, Assess, Assist and Arrange). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 40 and 70
- Confirmed diagnosis of Bipolar Disorder or Schizophrenia according to Diagnostic and Statistical Manual of Mental Disorder IV (DSM-IV-TR)
- Active smokers who currently consume at least 10 cigarettes a day, with a cumulative consumption of 10 packets/year or more.
Key exclusion criteria (6 listed)
- Previous respiratory diagnosis of: asthma, cystic fibrosis, tuberculosis, simple chronic bronchitis, restrictive pulmonary disease or bronchiectasis
- Acute respiratory symptoms
- Heart disease or advanced oncological processes
- Existence of a pathology which makes it advisable not to perform spirometry (recent pneumothorax, recent thoracic or abdominal surgery, aortic aneurysm, unstable angulation, retinal detachment, facial hemiparesis or oral/dental problems)
- Patients who, due to their intellectual disability or mental pathology, do not understand or cannot be forced to perform spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized information about lung damageChronic obstructive pulmonary disease (COPD) will be evaluated using spirometry. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months | Device | Experimental Group |
Primary outcome
Smoking cessation
Time frame: 12 months
Self-reported abstinence over the previous 7 days, confirmed by cooximetry with expired CO <10 ppm
COPD diagnosis
Time frame: 12 month
Presence of COPD and staging and percentage of forced expiratory volume at one second (FEV1) compared with expected level
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 9 Jan 2020.
- Derived from this study: PubMed 30642365Jaen-Moreno MJ, Feu N, Redondo-Ecija J, Montiel FJ, Gomez C, Del Pozo GI, Alcala JA, Gutierrez-Rojas L, Balanza-Martinez V, Chauca GM, Carrion L, Osuna MI, Sanchez MD, Caro I, Ayora M, Valdivia F, Lopez MS, Poyato JM, Sarramea F. Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial. Trials. 2019 Jan 14;20(1):47. doi: 10.1186/s13063-018-3139-9.
- Individual participant dataSharing planned: Undecided
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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.
Fernando Sarramea Crespo, Phd principal investigator
Hospital Universitario Reina Sofia Cordoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized information about lung damage in people with Severe Mental Disorder and Smoking Cessation, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
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 3 inclusion and 6 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Smoking cessation (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT03583203, which also lists 1 linked publication.
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 9 Jan 2020.