Intensive smoking cessation treatment among patients with a primary mental disorder

Intensive smoking cessation treatment among patients with a primary mental disorder: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12859609

Enrollment

Registered

2024-05-01

Start date

2024-02-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Intensive smoking cessation treatment for outpatient psychotherapeutic patients with nicotine dependence Mental and Behavioural Disorders

Interventions

The study is a single-center randomized controlled trial. Relative changes in dependence symptoms and symptoms of a mental disorder (post vs baseline, follow-up vs post, follow-up vs baseline) will be

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. >18 years of age 2. Exhibition of either harmful use of tobacco (F17.1 according to ICD-10) or tobacco dependence (F17.2 according to ICD-10) 3. Psychiatric primary diagnosis (F-Diagnosis according to ICD-10)

Exclusion criteria

Exclusion criteria: 1. Acute suicidality 2. Acute psychotic epsiode

Design outcomes

Primary

Measure	Time frame
1. Nicotine dependence is measured using: 1.1. The Fagerström Test for Nicotine Dependence at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.2. The measured carbon monoxide (CO) level in exhaled breath at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.3. Cotinin by self-applied urine tests at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.4. The WHO ASSIST questionnaire at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.5. The ICD-10 criteria for dependence at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 2. Symptom severity of the primary diagnosis is measured by specific questionnaires that target both disorder-specific symptoms (such as the Becks Depression Inventory-Revised) and diagnostic questionnaries across disorders such as the Brief Symptom Check List and the WHO Qualitiy of Life questionnaires. All questionnaires will be assessed at baseline (t0), post (to + 3 weeks),and both follow-up assessments (t0 + 6 weeks; t0 + 6 months).	—

Measure

Time frame

1. Nicotine dependence is measured using: 1.1. The Fagerström Test for Nicotine Dependence at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.2. The measured carbon monoxide (CO) level in exhaled breath at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.3. Cotinin by self-applied urine tests at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.4. The WHO ASSIST questionnaire at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 1.5. The ICD-10 criteria for dependence at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 2. Symptom severity of the primary diagnosis is measured by specific questionnaires that target both disorder-specific symptoms (such as the Becks Depression Inventory-Revised) and diagnostic questionnaries across disorders such as the Brief Symptom Check List and the WHO Qualitiy of Life questionnaires. All questionnaires will be assessed at baseline (t0), post (to + 3 weeks),and both follow-up assessments (t0 + 6 weeks; t0 + 6 months).

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Secondary

Measure	Time frame
1. Self-efficacy is measured using the Generalized Self-Efficacy Scale and the Self-Efficacy Scale for Smoking at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 2. Patients' motivation is measured by the Motivation to Quit Scale and the German version of the URICA (FEVER), the Scale for Stages of Change at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 3. Attitudes towards digital health applications measured using the Attitudes towards Psychological Online Interventions (APOI) questionnaire at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months)	—

Measure

Time frame

1. Self-efficacy is measured using the Generalized Self-Efficacy Scale and the Self-Efficacy Scale for Smoking at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 2. Patients' motivation is measured by the Motivation to Quit Scale and the German version of the URICA (FEVER), the Scale for Stages of Change at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months) 3. Attitudes towards digital health applications measured using the Attitudes towards Psychological Online Interventions (APOI) questionnaire at baseline (t0), post (t0 + 3 weeks) and both follow-up assessments (post + 6 weeks/ post + 6 months)

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Countries

Germany

Contacts

Public ContactEsra Otto

esra.otto@uni-siegen.de+49 (0)271 7404106

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026