Smoking cessation among people with severe mental illness: a study on effectiveness and implementatio

Recruiting

Conditions: Addiction
Severe Mental Illness
Smoking Cessation
10039628

Registration Number: NL-OMON54435

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 318

Inclusion Criteria

- Above 18 years old
- Smoker (>= 5 cigarettes) and wish to quit smoking
- Documented diagnosis of schizophrenia, other psychotic disorder and/or
disorders defined as severe mental illness according to Delespaul
consensusgroup at Maastricht University
- Dutch language skills

Exclusion Criteria

- Contra-indications (determined by a psychiatrist/physician) for participation
due to acute psychiatric crisis or somatic disease
- Pregnancy or breastfeeding in women at the time of inclusion
- Primary alcohol or other substance use disorder, with exception of cannabis
use disorder
- Lacking capacity to consent, to complete questionnaires, or participate in
peer support group session
- Non-Dutch speaking

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is smoking cessation after 12 months. This outcome<br /><br>will be validated by measuring the exhaled carbon monoxide (CO) level with a CO<br /><br>monitor. The measurement of CO level provides an immediate, non-invasive method<br /><br>of assessing smoking status. We defined smoking cessation as a CO reading less<br /><br>than 10 ppm. Additional smoking cessation parameters are the number of<br /><br>cigarettes smoked (reported by the patient) and scores on the Fagerström Test<br /><br>for Nicotine Dependence (FTND). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are physical health (physical fitness (6 minute walk<br /><br>test) and cardiovascular risk (i.e. blood pressure, lipid profile and glucose<br /><br>metabolism); mental health, including psychiatric symptoms (depression, anxiety<br /><br>and psychotic symptoms) and use of psychopharmaca, quality of life and<br /><br>self-efficacy. Finally, we will calculate BMI to assess weight change after the<br /><br>start of the smoking cessation intervention.</p><br>