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

Primary Purpose

Tobacco Use Disorder, Smoking Cessation, Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Smoking cessation program
Placebo Comparator: Brief Counselling
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Motivational Interviewing, Group Counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínic de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Intervention Group

Placebo Comparator: Brief Counselling

Arm Description

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.

Participants in the placebo group will receive a brief intervention for smoking cessation.

Outcomes

Primary Outcome Measures

Tobacco use changes from baseline to post-intervention
Number of cigarettes smoked in past 24 hours.
Motivation to quit smoking changes from baseline to post-intervention
Individuals will be assessed with the Richmond test.
Cotinine levels in urine changes from baseline to post-intervention
Urine cotinine levels

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2021
Last Updated
February 28, 2023
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05045326
Brief Title
Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
Acronym
ESCIM
Official Title
Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2021 (Actual)
Primary Completion Date
July 27, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Smoking Cessation, Mental Disorder
Keywords
Motivational Interviewing, Group Counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator: Brief Counselling
Arm Type
Placebo Comparator
Arm Description
Participants in the placebo group will receive a brief intervention for smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Comparator: Brief Counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tobacco use changes from baseline to post-intervention
Description
Number of cigarettes smoked in past 24 hours.
Time Frame
An average of 2 months
Title
Motivation to quit smoking changes from baseline to post-intervention
Description
Individuals will be assessed with the Richmond test.
Time Frame
An average of 2 months
Title
Cotinine levels in urine changes from baseline to post-intervention
Description
Urine cotinine levels
Time Frame
An average of 2 months
Secondary Outcome Measure Information:
Title
Nicotine dependence changes from baseline to post-intervention
Description
Change of self reported tobacco dependence using Fagerström Test for Nicotine Dependence.
Time Frame
An average of 2 months
Title
Self-efficacy to quit smoking changes from baseline to post-intervention
Description
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.
Time Frame
An average of 2 months
Title
Smoking knowledge changes from baseline to post-intervention
Description
Changes in smoking knowledge obtained through a knowledge questionnaire developed by the researchers.
Time Frame
An average of 2 months
Title
Trait and state anxiety changes from baseline to post-intervention
Description
Changes in anxiety obtained through the State-Trait Anxiety Inventory. Minimum value: 20. Maximum value: 80. Higher scores indicate greater anxiety.
Time Frame
An average of 2 months
Title
Depressive symptoms changes from baseline to post-intervention
Description
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.
Time Frame
An average of 2 months
Title
Self-reported clinically relevant psychological symptoms changes from baseline to post-intervention
Description
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.
Time Frame
An average of 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoni Gual, PhD, MD
Phone
+34932275400
Ext
3167
Email
TGUAL@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Antoni Gual, PhD, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Gual, PhD, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.who.int/teams/health-promotion/tobacco-control/who-report-on-the-global-tobacco-epidemic-2019
Description
The World Health Organization report on the global tobacco epidemic 2019: offer help to quit tobacco use" tracks the status of the tobacco epidemic and interventions to combat it.
URL
https://www.xchsf.cat/docs/460-Guia%20Tabac%20int%20cast.pdf
Description
Clinical Intervention guide on tobacco use in patients with mental disorders. Government of Catalonia. 2012.

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

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