Addiction Severe Mental Illness Smoking Cessation
Conditions
Interventions
The provided intervention consists of three components: 
1. Pharmacotherapy (Nicotine replacements: patches and gum
other registered 
medication for smoking cessation: Varenicline and Bupropion)
2. Cognitive Behavioural Therapy (CBT)
in groups 
3. Peer Support Groups. 
The intensity and frequency of individual behavioural support (CBT), and the 
dosage of the pharmacotherapy are determined individually according to the 
patients' needs. Over the course of the intervention, the intensity will 
decrease, i.e. the frequency of CBT sessions will decrease and the dose of 
medication will be reduced. The following scheme is proposed: 
1. Treatment period (12 weeks): 1x per week group CBT, individual consultation 
as desired
1x per week peer support
medication dosage as prescribed by a 
psychiatrist
2. Treatment period (16 weeks): 1x per month group CBT, individual consultation 
1x every two weeks peer support
medication dosage as prescribed by 
a psychiatrist
3. Treatment period (20 weeks): 1x per month group CBT, individual consultation 
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is smoking cessation after 12 months. This outcome will be validated by measuring the exhaled carbon monoxide (CO) level with a CO monitor. The measurement of CO level provides an immediate, non-invasive method of assessing smoking status. We defined smoking cessation as a CO reading less than 10 ppm. Additional smoking cessation parameters are the number of cigarettes smoked (reported by the patient) and scores on the Fagerström Test for Nicotine Dependence (FTND). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are physical health (physical fitness (6 minute walk test) and cardiovascular risk (i.e. blood pressure, lipid profile and glucose metabolism); mental health, including psychiatric symptoms (depression, anxiety and psychotic symptoms) and use of psychopharmaca, quality of life and self-efficacy. Finally, we will calculate BMI to assess weight change after the start of the smoking cessation intervention. | — |
Countries
Netherlands
Outcome results
None listed