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Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital

Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05045326
Acronym
ESCIM
Enrollment
150
Registered
2021-09-16
Start date
2021-05-30
Completion date
2024-07-30
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorder, Smoking Cessation, Tobacco Use Disorder

Keywords

Motivational Interviewing, Group Counseling

Brief summary

Background: Nicotine contained in tobacco is highly addictive and tobacco use is a major risk factor for cardiovascular and respiratory diseases. Every year, more than 8 million people die from tobacco use. Smoking-related mortality is significantly higher in people with serious mental illness. Is estimated that half of all deaths among individuals with mental illnesses are attributable to tobacco use. People with serious mental illness have greater daily tobacco consumption, nicotine dependence, and smoking relapse. While significant progress has been made in reducing tobacco use within the general population, rates of tobacco use remain high among individuals with mental illness. Smoking cessation often requires numerous attempts by these people. Thus, smokers with mental health illnesses may find it more difficult to quit, although highly motivated to quit. Smoking cessation during hospitalization (total or partial) is cost-effective, as it reduces hospital readmissions, and mortality, and improves smokers' quality of life. Available quitting aids are both safe and effective in supporting cessation in tobacco users with mental illness and stopping smoking is associated with an improvement in mental health. The investigators aimed to evaluate the feasibility and efficacy of adding an intensive smoking intervention to the usual treatment for patients with psychiatric disorders attending a day hospital of a tertiary hospital.

Detailed description

The investigators will perform a quasi-experimental, longitudinal, and prospective study in the mental health day hospital of the Hospital Clinic of Barcelona. Adults attending the day hospital and willing to participate, under informed consent, will be invited to participate. Consecutive eligible individuals will be recruited and will be assigned to two groups, the control group, and the experimental group. Initially, patients will be recruited for the control group, once the control group is completed the experimental group will begin. An assessment will be conducted at baseline (admission) and in the discharge. Sociodemographic and clinical data will be obtained.

Interventions

Participants will receive intensive treatment for smoking cessation during day hospital admission. The intervention is carried out individually and in an open-ended group. The treatment, provided by trained and multidisciplinary professionals (nursing, psychiatry, psychologist, occupational therapist, social work), includes psychological, psycho-educational support, and pharmacological treatment advice. The group intervention takes place once a week and is divided into six structured sessions that are repeated. Sessions include nicotine addiction and withdrawal, health consequences, benefits of quitting, motivation for change, triggers, coping responses, social support, decision making, pharmacological treatment advice and healthy lifestyle habits.

BEHAVIORALPlacebo Comparator: Brief Counselling

Participants will receive brief counseling on smoking cessation during their hospital stay. This brief intervention is based on motivational techniques to increase motivation to reduce tobacco use or to initiate treatment.

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Mental health day hospital inpatient. * Smoker of at least 1 cigarette per day, electronic cigarette, or heated tobacco product daily for at least 1 month. * Individuals who accept to participate in the study and give informed consent.

Exclusion criteria

* Cognitive impairment, dementia, or brain damage. * Medically unstable. * Explicitly demanding tobacco treatment. * Trying to quit smoking using another intervention. * Insufficient comprehension skills in Spanish or Catalan.

Design outcomes

Primary

MeasureTime frameDescription
Tobacco use changes from baseline to post-interventionAn average of 2 monthsNumber of cigarettes smoked in past 24 hours.
Motivation to quit smoking changes from baseline to post-interventionAn average of 2 monthsIndividuals will be assessed with the Richmond test.
Cotinine levels in urine changes from baseline to post-interventionAn average of 2 monthsUrine cotinine levels

Secondary

MeasureTime frameDescription
Trait and state anxiety changes from baseline to post-interventionAn average of 2 monthsChanges in anxiety obtained through the State-Trait Anxiety Inventory. Minimum value: 20. Maximum value: 80. Higher scores indicate greater anxiety.
Nicotine dependence changes from baseline to post-interventionAn average of 2 monthsChange of self reported tobacco dependence using Fagerström Test for Nicotine Dependence.
Self-reported clinically relevant psychological symptoms changes from baseline to post-interventionAn average of 2 monthsChanges in self-reported clinically relevant psychological symptoms through the Brief Symptom Inventory. Minimum value: 0. Maximum value: 72. Higher scores indicate higher levels of psychological distress.
Depressive symptoms changes from baseline to post-interventionAn average of 2 monthsChanges in depressive symptoms obtained through the Montgomery and Asberg Depression. Minimum value: 0 Maximum value: 60. A score of less than 10 points indicate the absence of depressive disorder.
Self-efficacy to quit smoking changes from baseline to post-interventionAn average of 2 monthsChange of self reported self-efficacy (using a Likert scale from 0 to 10). Minimum value: 0. Maximum value: 10. Higher scores indicate more self-efficacy to quit smoking.
Smoking knowledge changes from baseline to post-interventionAn average of 2 monthsChanges in smoking knowledge obtained through a knowledge questionnaire developed by the researchers.

Countries

Spain

Contacts

Primary ContactAntoni Gual, PhD, MD
TGUAL@clinic.cat+34932275400
Backup ContactAntoni Gual, PhD, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026