Intensive smoking cessation treatment among patients with a primary mental disorder
| ISRCTN | ISRCTN12859609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12859609 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1 |
| Sponsor | University of Siegen |
| Funder | Universität Siegen |
- Submission date
- 15/04/2024
- Registration date
- 01/05/2024
- Last edited
- 02/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Tobacco consumption is a leading global risk factor for premature death, with about six million premature deaths annually. Smokers with psychiatric diagnoses have higher levels of tobacco dependence, about twice as high as the general population.
Research indicates that stopping smoking has long-term positive effects on mental health, comparable to antidepressant treatments. Integration of tobacco cessation into psychotherapeutic interventions may be necessary for long-term success. The current care for smoking in patients with primary psychiatric diagnoses is considered inadequate. Uncertainty remains regarding therapy-optimizing factors, such as session frequency.
This study aims to examine an intensive smoking cessation treatment, consisting of six behaviorally oriented sessions combined with a digital health application, compared to a control condition, in outpatient psychotherapeutic patients with harmful use or dependence. This study will investigate whether a smoking cessation treatment is more effective than treatment as usual (TAU) at improving mental health status, such as perceived quality of life, changes in symptom severity of a primary diagnosis and nicotine dependence.
Who can participate?
Adult tobacco smokers who exhibit either harmful use of tobacco or dependence, fulfil the criteria for a psychiatric primary diagnosis and are currently in psychotherapeutic treatment
What does the study involve?
Participants will be randomly assigned to either the experimental group (diagnostic session + three regular therapy sessions + a six-session smoking cessation program + self-guided app treatment) or the treatment as usual (TAU) control condition (diagnostic session + three regular therapy sessions).
What are the possible benefits and risks of participating?
One possible benefit is that the smoking cessation program might reduce dependence and improve mental health next to physical health benefits related to smoking cessation. Implementing smoking interventions in standard psychotherapy might improve overall treatment effects on long-term symptom reduction.
Where is the study run from?
University of Siegen (Germany)
When is the study starting and how long is it expected to run for?
December 2023 to January 2027
Who is funding the study?
University of Siegen (Germany)
Who is the main contact?
Esra Otto, esra.otto@uni-siegen.de
Contact information
Public, Scientific, Principal investigator
Obergraben 23
Siegen
57072
Germany
| Phone | +49 (0)271 7404106 |
|---|---|
| esra.otto@uni-siegen.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Intensive smoking cessation treatment among patients with a primary mental disorder: a randomized controlled trial |
| Study objectives | The researchers expect a treatment effect on nicotine dependence and symptom severity of a primary mental disorder and general mental health status. Precisely, it is expected that smokers in the experimental condition will experience a significantly higher reduction of dependence and symptom severity than patients in the control condition during the post-treatment and follow-up measures when compared to the baseline measures. The researchers also expect a significantly higher reduction in the primary diagnosis’ severity, such as depression or anxiety severity, in the experimental condition versus the control condition when comparing baseline assessment to follow-up assessment. |
| Ethics approval(s) |
Approved 28/01/2024, Ethics Committee of the University of Siegen (Adolf-Reichwein-Str. 2a, Siegen, 57076, Germany; +49 (0)271 740-4819; ethikrat@uni-siegen.de), ref: ER_10_2024 |
| Health condition(s) or problem(s) studied | Intensive smoking cessation treatment for outpatient psychotherapeutic patients with nicotine dependence |
| Intervention | 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 compared between a group receiving an intensive behavioral smoking cessation treatment and a control group will be compared in a superiority design. The study employs a 2 (condition: smoking treatment vs control treatment) x 4 (time: baseline assessment, post assessment, 6-weeks-follow-up), 6-months-follow-up design. Eligible participants will be randomly assigned to either the experimental group (diagnostic session + three psychotherapeutic sessions + six-session smoking cessation program + self-guided app treatment) or the TAU control condition (diagnostic session + three psychotherapeutic sessions). Participants will undergo random allocation to either the experimental or control group at a 1:1 ratio. Given the study's design, participant blinding or therapist blinding post-allocation is not feasible. To mitigate bias during data assessment and analysis, research assistants involved in enrollment and data analysis will remain blinded to participants' group allocations. The duration of the intervention is 3 weeks. 6 weeks and 6 months after completion, follow-up measures occur. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Nicotine dependence is measured using: |
| Key secondary outcome measure(s) |
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) |
| Completion date | 01/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 63 |
| Key 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) |
| Key exclusion criteria | 1. Acute suicidality 2. Acute psychotic epsiode |
| Date of first enrolment | 01/02/2024 |
| Date of final enrolment | 01/01/2026 |
Locations
Countries of recruitment
- Germany
Study participating centre
57072
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The dataset will be available upon request from the corresponding author (Esra Otto, Esra.otto@uni-siegen.de). The data will be available after the overall trial end. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/07/2025 | 02/07/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/07/2025: Publication reference added.
15/04/2024: Study's existence confirmed by the Ethics Committee of the University of Siegen.
