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A Smoking Cessation Intervention for People with Severe Mental Illness

A smoking cessation intervention for people with severe mental illness: a randomised, controlled, clinical trial on effectiveness and implementation in FACT-teams

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29433
Enrollment
318
Registered
2021-10-11
Start date
2022-01-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe mental illness (Schizophrenia, schizotypical/schizoaffective disorder, mood/bipolar disorder, psychotic disorders)

Interventions

An integrative intervention consisting of behavioural counselling (cognitive-behavioural therapy and motivational interviewing) pharmacological treatment and peer support groups.

Sponsors

Vrije Universiteit Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
•CO-levels

Secondary

MeasureTime frame
• 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)

Contacts

Public ContactMüge Kücükaksu

Vrije Universiteit Amsterdam

m.kucukaksu@vu.nl0610819511

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)