Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital (ESCIM)

February 28, 2023 updated by: Hospital Clinic of Barcelona

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antoni Gual, PhD, MD
  • Phone Number: 3167 +34932275400
  • Email: TGUAL@clinic.cat

Study Contact Backup

  • Name: Antoni Gual, PhD, MD

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Intervention Group
Participants in the intervention group will receive an intensive motivational intervention with individual and group treatment for smoking cessation. The treatment, provided by trained professionals, will include psychological, psycho-educational support and pharmacological treatment advice.
Behavioral: Smoking cessation program

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.
Placebo Comparator: Placebo Comparator: Brief Counselling
Participants in the placebo group will receive a brief intervention for smoking cessation.
Behavioral: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tobacco use changes from baseline to post-intervention
Time Frame: An average of 2 months
Number of cigarettes smoked in past 24 hours.
An average of 2 months
Motivation to quit smoking changes from baseline to post-intervention
Time Frame: An average of 2 months
Individuals will be assessed with the Richmond test.
An average of 2 months
Cotinine levels in urine changes from baseline to post-intervention
Time Frame: An average of 2 months
Urine cotinine levels
An average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine dependence changes from baseline to post-intervention
Time Frame: An average of 2 months
Change of self reported tobacco dependence using Fagerström Test for Nicotine Dependence.
An average of 2 months
Self-efficacy to quit smoking changes from baseline to post-intervention
Time Frame: An average of 2 months
Change 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.
An average of 2 months
Smoking knowledge changes from baseline to post-intervention
Time Frame: An average of 2 months
Changes in smoking knowledge obtained through a knowledge questionnaire developed by the researchers.
An average of 2 months
Trait and state anxiety changes from baseline to post-intervention
Time Frame: An average of 2 months
Changes in anxiety obtained through the State-Trait Anxiety Inventory. Minimum value: 20. Maximum value: 80. Higher scores indicate greater anxiety.
An average of 2 months
Depressive symptoms changes from baseline to post-intervention
Time Frame: An average of 2 months
Changes 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.
An average of 2 months
Self-reported clinically relevant psychological symptoms changes from baseline to post-intervention
Time Frame: An average of 2 months
Changes 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.
An average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Antoni Gual, PhD, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2021

Primary Completion (Anticipated)

July 27, 2023

Study Completion (Anticipated)

July 30, 2024

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2019/0580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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