Smoking CessationViReTaNCT03707106
Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure
A study testing CBT smoking cessation, virtual reality based cue exposure and progressive muscle relaxation in people with Smoking Cessation, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
Cognitive-behavioral therapy (CBT) combined with medication is an established intervention for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded. Moreover, acceptance of drug treatment is partly very low. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- CBT smoking cessation, virtual reality based cue exposure and progressive muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2017to 2 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- daily smokers for at least 2 years, smoking minimum 10 cigarettes a day
Who cannot join
- pregnancy
- current participation in another smoking cessation program within 6 months before assignment
- current diagnosis of a psychiatric disease including a depression or substance use disorder (excluding nicotine dependency)
- lifetime diagnosis of a psychiatric disease : psychosis, bipolar affective disorder, posttraumatic stress disorder, conversion disorder.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Regensburg
Regensburg
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: An Efficacy Study Using an Established Cognitive Behavioral Therapy Manual for Smoking Cessation Comparing the Benefit of Virtual Reality Cue Exposure to a Specific Stress Reduction Protocol for Relapse Prevention
Cognitive-behavioral therapy (CBT) combined with medication is an established intervention for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded. Moreover, acceptance of drug treatment is partly very low. Professional recommendation of drug treatment besides nicotine-replacement aids is restrained considering side effects and contraindications. Currently, cue exposure is highly discussed as intervention for craving reduction supporting CBT. There is evidence for benefits of cue exposure optimizing smoking cessation outcomes, as well as evidence for efficacy of exposure in virtual reality (VR) up to date.
However, this is the first randomized controlled study focusing on efficacy increases by VR cue exposure supporting an established CBT smoking cessation manual. The control group receives a specific stress reduction treatment (independent of smoking cues), namely, the Progressive Muscle Relaxation (PMR, according to Jacobson) additionally to the established smoking cessation CBT.
- Conditions
- Smoking Cessation
- Being tested
- CBT smoking cessation, virtual reality based cue exposure, progressive muscle relaxation
- Keywords
- virtual reality, cue exposure, progressive muscle relaxation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT smoking cessationBehavioural
an established protocol for smoking cessation based on cognitive behavioral therapy
virtual reality based cue exposureBehavioural
smoking cue exposure in virtual reality
progressive muscle relaxationBehavioural
Progressive muscle relaxation for unspecific stress reduction
| Study group | Role | What they receive |
|---|---|---|
| VR based cue exposure smoking cessation | Experimental | an established CBT intervention for smoking cessation supported by cue exposure in virtual reality Receives: Behavioral: CBT smoking cessation; Behavioral: virtual reality based cue exposure |
| PMR supported smoking cessation | Active comparator | an established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson) Receives: Behavioral: CBT smoking cessation; Behavioral: progressive muscle relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment
6-month continuous smoking abstinence according to the Russell Standard (West et al., 2005): no cigarette smoking assessed by self-report (number of smoked cigarettes) and a negative biochemical validation (CO measurement below 9) at the final follow-up. 6-month continuous smoking abstinence ordinal scale: 0=no abstinence, 1= either subjective or biochemical validation depicts no abstinence, 2= biochemical validated abstinence at the 6 months follow-up.
Measured: at the 6 month follow-up
Secondary outcomes (8)
Changes in smoking cue event-related potentials (ERP: LPP)
late positive potential (LPP) amplitude (Microvolts)
Measured: Differences from baseline to the 6 month follow-up
Changes in smoking cue event-related potentials (ERP:P3)
P3 amplitude (Microvolts) during avoidance of smoking cues
Measured: Differences from baseline to the 6 month follow-up
Changes in approach tendency to smoking pictures
Difference in reaction time (ms) bias berween neutral and smoking condition. Approach Bias is calculated as reaction time (ms) difference in avoidance and approach condition.
Measured: Differences from baseline to the 6 month follow-up
Changes in smoking cue reactivity related skin conductance level
Differences in conductance level (MicroSiemens) during smoking cue exposure and exposure to a neutral cue.
Measured: Differences from baseline to the 6 month follow-up
Changes in Theta and Alpha band power during smoking cue exposure
Differences in Alpha and Theta band power during smoking cue exposure and neutral cue exposure.
Measured: Differences from baseline to the 6 month follow-up
Changes in heartbeat-evoked potential during smoking cue exposure
Amplitude (microvolts) of heartbeat-evoked potential
Measured: Differences from baseline to the 6 month follow-up
Subjective ratings on the smoking self-efficacy scale
Subjective ratings on on the German version of the self-efficacy scale for smoking cessation (Jäkle et al., 1999) total score for the questionnaire: minium total score (sum): 9 (low self-efficacy, worse outcome), maximum total score= 45 (high self-efficacy, better outcome)
Measured: Differences from baseline to the 6 month follow-up
Number of daily smoked cigarettes after smoking cessation
Sum of self-reported smoked cigarettes after smoking cessation
Measured: Time Frame: Differences from smoking cessation to the 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study startJan 2017
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regensburg
- Responsible party
- Principal investigator, Anil Batra, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707106
- Sponsor's protocol ID
- 70111871
- Acronym
- ViReTa
- Status last verified
- Dec 2023
- First submitted
- 5 Apr 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kroczek AM, Schroder B, Rosenbaum D, Muhleck A, Diemer J, Muhlberger A, Ehlis AC, Batra A. Virtual reality cue exposure as an add-on to smoking cessation group therapy: a randomized controlled trial. Addict Sci Clin Pract. 2025 Apr 11;20(1):34. doi: 10.1186/s13722-025-00561-2.
PubMed 40211338
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Study Using an Established Cognitive Behavioral Therapy Manual for Smoking Cessation Comparing the Benefit of Virtual Reality Cue Exposure to a Specific Stress Reduction Protocol for Relapse Prevention
- ClinicalTrials.gov ID
- NCT03707106
- Acronym / sponsor ID
- ViReTa / 70111871
- Conditions
- Smoking Cessation
- Keywords
- virtual reality, cue exposure, progressive muscle relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University of Regensburg
- Study start
- Jan 2017 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive-behavioral therapy (CBT) combined with medication is an established intervention for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded. Moreover, acceptance of drug treatment is partly very low. Professional recommendation of drug treatment besides nicotine-replacement aids is restrained considering side effects and contraindications. Currently, cue exposure is highly discussed as intervention for craving reduction supporting CBT. There is evidence for benefits of cue exposure optimizing smoking cessation outcomes, as well as evidence for efficacy of exposure in virtual reality (VR) up to date.
However, this is the first randomized controlled study focusing on efficacy increases by VR cue exposure supporting an established CBT smoking cessation manual. The control group receives a specific stress reduction treatment (independent of smoking cues), namely, the Progressive Muscle Relaxation (PMR, according to Jacobson) additionally to the established smoking cessation CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR based cue exposure smoking cessation | Experimental | Behavioral: CBT smoking cessation, Behavioral: virtual reality based cue exposurean established CBT intervention for smoking cessation supported by cue exposure in virtual reality |
| PMR supported smoking cessation | Active comparator | Behavioral: CBT smoking cessation, Behavioral: progressive muscle relaxationan established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- daily smokers for at least 2 years, smoking minimum 10 cigarettes a day
Key exclusion criteria (4 listed)
- pregnancy
- current participation in another smoking cessation program within 6 months before assignment
- current diagnosis of a psychiatric disease including a depression or substance use disorder (excluding nicotine dependency)
- lifetime diagnosis of a psychiatric disease : psychosis, bipolar affective disorder, posttraumatic stress disorder, conversion disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT smoking cessationan established protocol for smoking cessation based on cognitive behavioral therapy | Behavioural | PMR supported smoking cessation, VR based cue exposure smoking cessation |
| virtual reality based cue exposuresmoking cue exposure in virtual reality | Behavioural | VR based cue exposure smoking cessation |
| progressive muscle relaxationProgressive muscle relaxation for unspecific stress reduction | Behavioural | PMR supported smoking cessation |
Primary outcome
Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment
Time frame: at the 6 month follow-up
6-month continuous smoking abstinence according to the Russell Standard (West et al., 2005): no cigarette smoking assessed by self-report (number of smoked cigarettes) and a negative biochemical validation (CO measurement below 9) at the final follow-up. 6-month continuous smoking abstinence ordinal scale: 0=no abstinence, 1= either subjective or biochemical validation depicts no abstinence, 2= biochemical validated abstinence at the 6 months follow-up.
8 secondary outcomes
Changes in smoking cue event-related potentials (ERP: LPP)
Time frame: Differences from baseline to the 6 month follow-up
Changes in smoking cue event-related potentials (ERP:P3)
Time frame: Differences from baseline to the 6 month follow-up
Changes in approach tendency to smoking pictures
Time frame: Differences from baseline to the 6 month follow-up
Changes in smoking cue reactivity related skin conductance level
Time frame: Differences from baseline to the 6 month follow-up
Changes in Theta and Alpha band power during smoking cue exposure
Time frame: Differences from baseline to the 6 month follow-up
Changes in heartbeat-evoked potential during smoking cue exposure
Time frame: Differences from baseline to the 6 month follow-up
Subjective ratings on the smoking self-efficacy scale
Time frame: Differences from baseline to the 6 month follow-up
Number of daily smoked cigarettes after smoking cessation
Time frame: Time Frame: Differences from smoking cessation to the 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 40211338Kroczek AM, Schroder B, Rosenbaum D, Muhleck A, Diemer J, Muhlberger A, Ehlis AC, Batra A. Virtual reality cue exposure as an add-on to smoking cessation group therapy: a randomized controlled trial. Addict Sci Clin Pract. 2025 Apr 11;20(1):34. doi: 10.1186/s13722-025-00561-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT smoking cessation, virtual reality based cue exposure and progressive muscle relaxation in people with Smoking Cessation, run by University Hospital Tuebingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment (time frame: at the 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.