The effectiveness of a standardized tobacco cessation program on addiction patients undergoing long-term rehabilitation
| ISRCTN | ISRCTN15684371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15684371 |
- Submission date
- 06/03/2024
- Registration date
- 07/03/2024
- Last edited
- 14/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This research explores the effectiveness of a specific program designed to help people stop smoking within a group of patients receiving long-term treatment for addiction. The goal is to see if this program can reduce their reliance on tobacco and improve both psychological and physical health aspects.
Who can participate?
Tobacco dependent adults over 18 years old who are receiving inpatient treatment for addiction and want to quit smoking can join the study. There are no other strict requirements for participation.
What does the study involve?
Participants are divided into two groups: one group takes part in a six-week tobacco cessation program, while the other receives usual care without this specific program. We will compare changes in tobacco use and dependence, craving, self-efficacy, psychopathological symptoms, and heart rate variability before and after the program.
What are the possible benefits and risks of participating?
Participants might reduce their tobacco use and improve self-confidence and physical health indicators. There are minimal risks involved, mainly related to the emotional and physical challenges of quitting smoking.
Where is the study run from?
The study is conducted at the Schloss Johnsdorf addiction clinic, operated by the Grüner Kreis society (Austria)
When is the Study Starting and How Long is it Expected to Run For?
November 2022 to March 2023
Who is Funding the Study?
The Grüner Kreis Society (Austria)
Who is the Main Contact?
Prof. DDr. Human-Friedrich Unterrainer
human.unterrainer@univie.ac.at
Contact information
Public, Principal Investigator
Sigmund Freud PrivatUniversität Wien, Campus Prater, Freudplatz 1
Vienna
A-1020
Austria
| Phone | +43 69918195990 |
|---|---|
| human.unterrainer@sfu.ac.at |
Scientific
Medical University Vienna
Department of Psychoanalysis and Psychotherapy
Währinger Gürtel 18-20
Vienna
1090
Austria
 ORCID ID |
0009-0003-2932-9029 |
|---|---|
| Phone | +43 1 40400-30730 |
| juergen.fuchshuber@meduniwien.ac.at |
Study information
| Study design | Non-randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effectiveness of a standardized tobacco cessation program on psychophysiological parameters in addiction patients undergoing long-term rehabilitation: a quasi-experimental pilot study |
| Study acronym | SToP-PLaRe |
| Study objectives | Primary Outcomes Hypotheses: Hypothesis 1 (Tobacco Dependence): There will be a difference in tobacco dependence between participants in the intervention group (IG), who undergo the standardized tobacco cessation program, and the control group receiving Treatment As Usual (TAUG). Hypothesis 2 (Cigarettes Per Day (CPD)): There will be a difference in the number of smoked cigarettes per day (CPD) between participants in the IG and participants in the TAUG. Hypothesis 3 ( Craving): There will be a difference in craving between participants in the IG and participants in the TAUG. Secondary Outcomes Hypotheses: Hypothesis 4 (Heart Rate Variability (HRV)): There will be a difference in HRV measurements between participants in the IG and the TAUG. Hypothesis 5 (Comorbid Psychiatric Symptoms): There will be a difference in the severity of comorbid psychiatric symptoms between participants in the IG and the TAUG. Hypothesis 6 (self-efficacy): There will be a difference in the self-efficacy between participants in the IG and the TAUG. |
| Ethics approval(s) |
Approved 23/12/2022, Ethikkommission der Universität Graz (Universitätsplatz 3, Graz, 8010, Austria; +43 (0) 316 / 380-1052; ethikkommission@uni-graz.at), ref: GZ. 39/30/63 ex 2022/23 |
| Health condition(s) or problem(s) studied | Tobacco addiction in patients diagnosed with Mental and behavioral disorders due to multiple drug use and use of other psychoactive substances, dependence syndrome (F19.2) |
| Intervention | This non-randomized interventional study examines the potential benefit of a standardized tobacco cessation program in a group of patients undergoing long-term addiction treatment. An intervention group (IG; participants in the program) and a control group receiving Treatment As Usual Group (TAUG; non-participants in the program) in an inpatient addiction clinic (single center). The study design was a quasi-experimental controlled trial, without random assignment. None of the participants took part in previous smoking cessation programs. No additional smoking cessation medication was implemented in the study. Treatment as usual: Addiction treatment in a therapeutic community specialized for the treatment of F19.2. Intervention group: The “smoke free in 6 weeks” program is a standardized behavioral therapy intervention that takes place once a week for 1.5 hours over six weeks and is provided by the Austrian health insurance provider Österreichische Gesundheitskasse (ÖGK). Held in the therapeutic community, it employed behavioral therapy coupled with personalized recommendations for nicotine replacement. The Austrian Health Insurance standard for therapy guided the program's content, which was tailored for inpatient clients. Various behavioral therapy techniques, including building motivation, behavioral observation, stimulus and self-control, as well as operant methods were applied in the group sessions. The primary aim was to help clients achieve smoking cessation, favoring this approach over gradual reduction methods. To support ongoing abstinence and motivation, participants were directed to additional resources such as the Smoke-Free App, Smoke-Free Phone, and regional outpatient cessation services. This program was led by a clinical psychologist. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Tobacco dependence is measured by the The Fagerström Test for Cigarette Dependence (FTND) at baseline and 1,5 weeks after the intervention. 2. Smoked cigarettes per day is measured by the The Fagerström Test for Cigarette Dependence (FTND) at baseline and 1,5 weeks after the intervention. 3. Craving is measured by the Mannheim Craving Scale (MaCS) at baseline and 1,5 weeks after the intervention. |
| Secondary outcome measures | 1. Heart Rate Variability is measured using Electrocardiography at baseline and 1,5 weeks after the intervention. 2. Psychiatric Symptoms are measured using the Brief Symptom Inventory (BSI-18) at baseline and 1,5 weeks after the intervention. 3. Self-efficacy is measured using the Self-Efficacy Scale (SWE) at baseline and 1,5 weeks after the intervention. |
| Overall study start date | 01/01/2022 |
| Completion date | 20/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Based on A-priori sample size calculations were performed with G-Power: A minimum sample size of 46 subjects |
| Total final enrolment | 56 |
| Key inclusion criteria | 1. voluntary participation 2. a current tobacco dependence (F17.2) 3. a current poly-drug use disorder (F19.2) 4. the desire to quit smoking 5. an age > 18 years. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/11/2022 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Austria
Study participating centre
Johnsdorf Brunn
8350
Austria
Sponsor information
University/education
Institut für Religionswissenschaft
Kath.-Theol. Fakultät
Universität Wien
Schenkenstraße 8-10/5. Stock
Vienna
1010
Austria
| Phone | +43-1-4277-31601 |
|---|---|
| religionswissenschaft@univie.ac.at | |
| Website | https://rw-ktf.univie.ac.at/ |
"ROR" |
https://ror.org/03prydq77 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in BMC medicine |
| IPD sharing plan | The datsets generated during and/or analysed during the current study will be available upon request to Prof. DDr. Human-Friedrich Unterrainer (human.unterrainer@univie.ac.at) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 22/04/2024 | No | No | ||
| Results article | 01/05/2024 | 14/05/2024 | Yes | No |
Additional files
Editorial Notes
14/05/2024: Publication reference added.
22/04/2024: Basic results uploaded as an additional file and the total final enrolment was changed from 52 to 56.
07/03/2024: Trial's existence confirmed by Ethikkommission der Universität Graz.
