Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure

Smoking Cessation Clinical Trial

— ViReTa  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707106
• Other study ID #: 70111871
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2, 2021

Study information

• Verified date: December 2023
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• CBT smoking cessation
an established protocol for smoking cessation based on cognitive behavioral therapy
• virtual reality based cue exposure
smoking cue exposure in virtual reality
• progressive muscle relaxation
Progressive muscle relaxation for unspecific stress reduction

Locations

Country	Name	City	State
Germany	University Regensburg	Regensburg
Germany	University Hospital Tuebingen	Tuebingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?nal 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
Secondary	Changes in smoking cue event-related potentials (ERP: LPP)	late positive potential (LPP) amplitude (Microvolts)	Differences from baseline to the 6 month follow-up
Secondary	Changes in smoking cue event-related potentials (ERP:P3)	P3 amplitude (Microvolts) during avoidance of smoking cues	Differences from baseline to the 6 month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in heartbeat-evoked potential during smoking cue exposure	Amplitude (microvolts) of heartbeat-evoked potential	Differences from baseline to the 6 month follow-up
Secondary	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
Secondary	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