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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
246
an established protocol for smoking cessation based on cognitive behavioral therapy
smoking cue exposure in virtual reality
Progressive muscle relaxation for unspecific stress reduction
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
University Regensburg
Regensburg, Germany
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.
Time frame: at the 6 month follow-up
Changes in smoking cue event-related potentials (ERP: LPP)
late positive potential (LPP) amplitude (Microvolts)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Differences from baseline to the 6 month follow-up
Changes in heartbeat-evoked potential during smoking cue exposure
Amplitude (microvolts) of heartbeat-evoked potential
Time frame: 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)
Time frame: 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: Time Frame: Differences from smoking cessation to the 6 month follow-up
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