Intensive smoking cessation treatment among patients with a primary mental disorder

ISRCTN ISRCTN12859609
DOI https://doi.org/10.1186/ISRCTN12859609
Secondary identifying numbers 1
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Ms Esra Otto
Public, Scientific, Principal Investigator

Obergraben 23
Siegen
57072
Germany

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

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other therapist office
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleIntensive smoking cessation treatment among patients with a primary mental disorder: a randomized controlled trial
Study objectivesThe 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) studiedIntensive smoking cessation treatment for outpatient psychotherapeutic patients with nicotine dependence
InterventionThe 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 typeBehavioural
Primary outcome measure1. 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).
Secondary outcome measures1. 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)
Overall study start date01/12/2023
Completion date01/01/2027

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants63
Key inclusion criteria1. >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 criteria1. Acute suicidality
2. Acute psychotic epsiode
Date of first enrolment01/02/2024
Date of final enrolment01/01/2026

Locations

Countries of recruitment

  • Germany

Study participating centre

Psychotherapeutische Hochschulambulanz der Universität Siegen (Psychotherapeutic outpatient clinic of the University of Siegen)
Siegen
57072
Germany

Sponsor information

University of Siegen
University/education

Adolf-Reichwein Str. 2a
Siegen
57076
Germany

Phone +49 (0)2717400
Email presse@uni-siegen.de
Website uni-siegen.de
ROR logo "ROR" https://ror.org/02azyry73

Funders

Funder type

University/education

Universität Siegen
Government organisation / Universities (academic only)
Alternative name(s)
University of Siegen
Location
Germany

Results and Publications

Intention to publish date01/02/2027
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan1. Planned publication of the study protocol in Trials
2. Planned publication in a high-impact peer-reviewed journal
IPD sharing planThe 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

Editorial Notes

02/07/2025: Publication reference added.
15/04/2024: Study's existence confirmed by the Ethics Committee of the University of Siegen.