No registrations found.
ID
Source
Brief title
Health condition
Severe mental illness (Schizophrenia, schizotypical/schizoaffective disorder, mood/bipolar disorder, psychotic disorders); Addiction
Sponsors and support
Intervention
Outcome measures
Primary outcome
• CO-levels
Secondary outcome
• Fagerström Test for Nicotine Dependence (FTND)
• Health of the Nation Outcome Scales (HoNOS)
• Hospital Anxiety and Depression Scale (HADS)
• 12 item Short Form-12 (SF-12) mental and physical component scores
• WHO Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST)
• Patient Activation Measure (PAM-13)
Background summary
This study aims to evaluate the effectiveness and implementation of a smoking cessation intervention tailored for people with severe mental illness, such as schizphrenia or psychotic disorders. The intervention consists of three core components: 1. Pharmacological treatment; 2. Behavioural counselling (based on cognitive-behavioural therapy and motivational interviewing) and 3. Peer support. It was designed based on the outcomes of a Delphi study with five experts from the field.
Study objective
It is hypothesised that the bespoke smoking intervention is more effective than usual care to reduce nicotine dependence and smoking for people with severe mental illness in FACT-teams in the Netherlands.
Study design
Baseline, 3-months, 6-months, 12-months
Intervention
An integrative intervention consisting of behavioural counselling (cognitive-behavioural therapy and motivational interviewing) pharmacological treatment and peer support groups.
Inclusion criteria
• Documented diagnosis of SMI
• Age ≥18
• Being treated in a FACT-team in the Netherlands
• Current smoker (≥ 5 cigarettes) without a quit attempt in the prior month
• Expresses an interest in stopping smoking
• Willing and able to sign informed consent
Exclusion criteria
• Contra-indications for participation due to acute psychiatric crisis or somatic diseases (e.g. surgery, cancer)
• Documented primary diagnosis of substance abuse disorder according to the DSM-5 (with exception of cannabis use disorder)
• Subjects with a cognitive impairment sufficient to interfere with their ability to provide informed consent, complete study questionnaires, or participate in the intervention
• Women who are pregnant or breastfeeding at the time of inclusion
• Subjects not able to communicate in the Dutch language
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9783 |
| Other | METc VUmc : 2021.0158 |