Primary objectives (after 1 year): - to improve smoking cessation- to reduce number of smoked cigarettes Secondary objectives (after 1 year): - to reduce psychiatric symptoms such as depression, psychotic symptoms and anxiety- to improve physical…
ID
Source
Brief title
Condition
- Other condition
- Schizophrenia and other psychotic disorders
Synonym
Health condition
Addiction
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Smoking among adults with serious mental illness (SMI) is highly prevalent and
strongly associated with poor health. About 50-80% people with SMI smoke, which
is at least three times the rate in the general population.Smoking is the
leading cause of preventable morbidity and mortality,with reduced life
expectancy. Smoking cessation is the single most powerful intervention for
reducing these health inequalities. A limited number of studies shows that
pharmacological treatment combined with behavioural support interventions
significantly improves outcomes for smokers with SMI. However, more studies are
needed focusing on both the implementation and the effectiveness of smoking
cessation intervention, with the active engagement of both mental health
professionals and individuals with SMI.
In the Netherlands, treatment for these patients is mainly offered by Flexible
Assertive Community Treatment (FACT) teams. These FACT-teams form an unique
possibility to deliver and support smoking cessation interventions.
Study objective
Primary objectives (after 1 year):
- to improve smoking cessation
- to reduce number of smoked cigarettes
Secondary objectives (after 1 year):
- to reduce psychiatric symptoms such as depression, psychotic symptoms and
anxiety
- to improve physical health (physical fitness and cardiovascular risks)
- to improve quality of life and health related self-efficacy
Study design
The study will consist of a cluster randomized controlled clinical trial with a
1 year follow-up period. Effectiveness of the intervention will be evaluated in
comparison with usual care. Eligible participants will be randomly allocated to
the smoking cessation intervention or usual care. This multicentre study will
recruit the 216 participants form approximately 21 FACT-teams across the
Netherlands. Including inclusion of participants, analysis and reporting phase,
the total duration of the study will be 48 months.
Intervention
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
as desired; 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
as desired; 1x per month peer support; medication dosage as prescribed by a
psychiatrist
The intervention group is compared with a control group that receives care as
usual in a FACT-team ('treatment as usual') and will have access to all
standard smoking cessation aids.
Study burden and risks
Benefits:
By participating, patients have the opportunity to overcome their addiction and
improve their mental and physical health by quitting smoking. In addition,
patients can gain deeper insights into their smoking behaviour and underlying
emotional difficulties, which may have a positive effect on their psychological
treatment.
Burden:
Participation in the intervention proposed in this research means that patients
will voluntarily commit to follow a complex programme. This might be perceived
as a burden, especially in the more intensive starting phase during which some
patients might struggle more with withdrawal symptoms after smoking cessation.
During this study, the subjects will be assessed at four timepoints (Baseline,
3-, 6- and 12-month follow-up) and a selection of participants will participate
in qualitative interviews. At 3-month follow-up assessment only the primary
study parameters will be registered (smoking status, carbon monoxide level,
nicotine dependence questionnaire). Furthermore, the process of quitting to
smoke can be experienced as mentally and physically challenging due to physical
and psychological withdrawal.
Risks:
A number of risks are known when using nicotine replacements and medication for
nicotine addiction. According to the package insert, possible side effects (in
10-30 in 100 people) of medication include headache, dry mouth, insomnia and
nausea.
The nicotine replacements that will be offered in this intervention are patches
and chewing gum. Known risks of nicotine patches and chewing gum are mild skin
irritation, dizziness, headache and nausea. We don't expect any risks
associated with therapeutic group sessions and peer support.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76469.029.21 |