Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure
ViReTa
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
1 other identifier
interventional
246
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2021
CompletedDecember 5, 2023
December 1, 2023
4.5 years
April 5, 2018
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Changes in smoking cue event-related potentials (ERP: LPP)
Differences from baseline to the 6 month follow-up
Changes in smoking cue event-related potentials (ERP:P3)
Differences from baseline to the 6 month follow-up
Changes in approach tendency to smoking pictures
Differences from baseline to the 6 month follow-up
Changes in smoking cue reactivity related skin conductance level
Differences from baseline to the 6 month follow-up
Changes in Theta and Alpha band power during smoking cue exposure
Differences from baseline to the 6 month follow-up
- +3 more secondary outcomes
Study Arms (2)
VR based cue exposure smoking cessation
EXPERIMENTALan established CBT intervention for smoking cessation supported by cue exposure in virtual reality
PMR supported smoking cessation
ACTIVE COMPARATORan established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson)
Interventions
an established protocol for smoking cessation based on cognitive behavioral therapy
smoking cue exposure in virtual reality
Progressive muscle relaxation for unspecific stress reduction
Eligibility Criteria
You may qualify if:
- daily smokers for at least 2 years, smoking minimum 10 cigarettes a day
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingenlead
- University of Regensburgcollaborator
Study Sites (2)
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
University Regensburg
Regensburg, Germany
Related Publications (1)
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.
PMID: 40211338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Head of Psychiatry
Study Record Dates
First Submitted
April 5, 2018
First Posted
October 16, 2018
Study Start
January 1, 2017
Primary Completion
July 2, 2021
Study Completion
July 2, 2021
Last Updated
December 5, 2023
Record last verified: 2023-12