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OpenTrials
Completed

NCT Number: NCT03583203

Tobacco Intensive Motivational and Estimate Risk

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

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Key information

Conditions

Severe Mental Disorder Behavior Bipolar Disorder Bipolar and Related Disorders COPD Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Smoking Cessation

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fernando Sarramea Crespo

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

personalized information about lung damage

Device

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

Primary outcomes

  1. Smoking cessation

    Time frame: 12 months

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

  2. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba

Other Gov

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Efficacy in Patients With Severe Mental Disorders of an Intensive Motivational Interventional Programme Offering Individualized Information on Respiratory Damage for Smoking Cessation

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 11, 2018
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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