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| Name | Class |
|---|---|
| University of Regensburg | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR based cue exposure smoking cessation | Experimental | an established CBT intervention for smoking cessation supported by cue exposure in virtual reality |
|
| PMR supported smoking cessation | Active Comparator | an established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT smoking cessation | Behavioral | an established protocol for smoking cessation based on cognitive behavioral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at the 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in smoking cue event-related potentials (ERP: LPP) | late positive potential (LPP) amplitude (Microvolts) | Differences from baseline to the 6 month follow-up |
| Changes in smoking cue event-related potentials (ERP:P3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany | ||
| University Regensburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40211338 | Derived | 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. |
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| virtual reality based cue exposure | Behavioral | smoking cue exposure in virtual reality |
|
| progressive muscle relaxation | Behavioral | Progressive muscle relaxation for unspecific stress reduction |
|
P3 amplitude (Microvolts) during avoidance of smoking cues
| 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. | 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. | 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. | Differences from baseline to the 6 month follow-up |
| Changes in heartbeat-evoked potential during smoking cue exposure | Amplitude (microvolts) of heartbeat-evoked potential | 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) | 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 | Time Frame: Differences from smoking cessation to the 6 month follow-up |
| Regensburg |
| Germany |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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