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

Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Recruiting
CT.gov ID
NCT05045326
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smoking cessation program
  • Behavioral: Placebo Comparator: Brief Counselling
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
Actual Study Start Date :
May 30, 2021
Actual Primary Completion Date :
Jul 27, 2021
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Tobacco use changes from baseline to post-intervention [An average of 2 months]

    Number of cigarettes smoked in past 24 hours.

  2. Motivation to quit smoking changes from baseline to post-intervention [An average of 2 months]

    Individuals will be assessed with the Richmond test.

  3. Cotinine levels in urine changes from baseline to post-intervention [An average of 2 months]

    Urine cotinine levels

Secondary Outcome Measures

  1. Nicotine dependence changes from baseline to post-intervention [An average of 2 months]

    Change of self reported tobacco dependence using Fagerström Test for Nicotine Dependence.

  2. Self-efficacy to quit smoking changes from baseline to post-intervention [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.

  3. Smoking knowledge changes from baseline to post-intervention [An average of 2 months]

    Changes in smoking knowledge obtained through a knowledge questionnaire developed by the researchers.

  4. Trait and state anxiety changes from baseline to post-intervention [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.

  5. Depressive symptoms changes from baseline to post-intervention [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.

  6. Self-reported clinically relevant psychological symptoms changes from baseline to post-intervention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clínic de Barcelona Barcelona Spain 08036

Sponsors and Collaborators

  • Hospital Clinic of Barcelona

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT05045326
Other Study ID Numbers:
  • HCB/2019/0580
First Posted:
Sep 16, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Clinic of Barcelona
Motivational Interviewing
Group Counseling
Additional relevant MeSH terms:
Disease
Tobacco Use Disorder
Mental Disorders

Study Results

No Results Posted as of Sep 16, 2021