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

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: CBT smoking cessation; Behavioral: virtual reality based cue exposure; Behavioral: progressive muscle relaxation

• Registration Number: NCT03707106
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-16
• Primary Completion: 2021-07-02
• Study Completion: 2021-07-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMR supported smoking cessation	CBT smoking cessation	an established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson)
VR based cue exposure smoking cessation	virtual reality based cue exposure	an established CBT intervention for smoking cessation supported by cue exposure in virtual reality
PMR supported smoking cessation	progressive muscle relaxation	an established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson)
VR based cue exposure smoking cessation	CBT smoking cessation	an established CBT intervention for smoking cessation supported by cue exposure in virtual reality

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 smoking cue event-related potentials (ERP: LPP)	Differences from baseline to the 6 month follow-up	late positive potential (LPP) amplitude (Microvolts)
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 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.
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.

Trial Locations

Locations (2)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Baden-Württemberg, Germany

University Regensburg; 🇩🇪 Regensburg, Germany