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CompletedNCT03583203Updated Jan 9, 2020

Tobacco Intensive Motivational and Estimate Risk

An interventional study of personalized information about lung damage in Severe Mental Disorder, Smoking Cessation and COPD, sponsored by Hospital Universitario Reina Sofia de Cordoba. Completed at 1 site in Spain. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by Hospital Universitario Reina Sofia de Cordoba · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Severe Mental Disorder
  • Smoking Cessation
  • COPD

Keywords

  • schizophrenia
  • bipolar disorder
  • tobacco
  • COPD
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In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 230 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

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

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    Experimental Group

    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.

    Device: personalized information about lung damage

  • No intervention
    Control Group

    The control intervention lasts 30 minutes and will be structured around the 5 A's technique (Ask, Advice, Assess, Assist and Arrange).

Interventions

  • Devicepersonalized information about lung damage

    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

06

What researchers measure

Primary outcomes

  1. Smoking cessation

    Self-reported abstinence over the previous 7 days, confirmed by cooximetry with expired CO \<10 ppm

    Time frame: 12 months

  2. COPD diagnosis

    Presence of COPD and staging and percentage of forced expiratory volume at one second (FEV1) compared with expected level

    Time frame: 12 month

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Study locations

1 site
  • Fernando Sarramea Crespo
    Cordoba, 14004, Spain
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03583203
Lead sponsor
Hospital Universitario Reina Sofia de Cordoba
Collaborators
Instituto de Salud Carlos III
Responsible party
Fernando Sarramea Crespo (Principal Investigator, Hospital Universitario Reina Sofia de Cordoba) — Principal investigator
First posted
Jul 11, 2018
Start date
Jul 12, 2018
Primary completion
Dec 1, 2018
Completion
Dec 31, 2019
Last update
Jan 9, 2020

Study contacts

Fernando Sarramea Crespo, Phd
principal investigator · Hospital Universitario Reina Sofia Cordoba

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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