Smoking Cessation
Conditions
Keywords
virtual reality, cue exposure, progressive muscle relaxation
Brief 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. 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.
Interventions
BEHAVIORALCBT smoking cessation
an established protocol for smoking cessation based on cognitive behavioral therapy
BEHAVIORALvirtual reality based cue exposure
smoking cue exposure in virtual reality
BEHAVIORALprogressive muscle relaxation
Progressive muscle relaxation for unspecific stress reduction
Sponsors
University of Regensburg
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* daily smokers for at least 2 years, smoking minimum 10 cigarettes a day
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in smoking cue event-related potentials (ERP:P3) | Differences from baseline to the 6 month follow-up | P3 amplitude (Microvolts) during avoidance of smoking cues |
| Changes in approach tendency to smoking pictures | Differences from baseline to the 6 month follow-up | 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. |
| Changes in smoking cue reactivity related skin conductance level | Differences from baseline to the 6 month follow-up | Differences in conductance level (MicroSiemens) during smoking cue exposure and exposure to a neutral cue. |
| Changes in smoking cue event-related potentials (ERP: LPP) | Differences from baseline to the 6 month follow-up | late positive potential (LPP) amplitude (Microvolts) |
| Changes in heartbeat-evoked potential during smoking cue exposure | Differences from baseline to the 6 month follow-up | Amplitude (microvolts) of heartbeat-evoked potential |
| Subjective ratings on the smoking self-efficacy scale | Differences from baseline to the 6 month follow-up | 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) |
| Number of daily smoked cigarettes after smoking cessation | Time Frame: Differences from smoking cessation to the 6 month follow-up | Sum of self-reported smoked cigarettes after smoking cessation |
| Changes in Theta and Alpha band power during smoking cue exposure | Differences from baseline to the 6 month follow-up | Differences in Alpha and Theta band power during smoking cue exposure and neutral cue exposure. |
Countries
Germany
Outcome results
None listed