Clinical trial NCT03707106: Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: virtual reality
cue exposure
progressive muscle relaxation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University of Regensburg
First posted: 2018-10-16
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment
timeFrame: at the 6 month follow-up
Secondary outcomes:
measure: Changes in smoking cue event-related potentials (ERP: LPP)
timeFrame: Differences from baseline to the 6 month follow-up
measure: Changes in smoking cue event-related potentials (ERP:P3)
timeFrame: Differences from baseline to the 6 month follow-up
measure: Changes in approach tendency to smoking pictures
timeFrame: Differences from baseline to the 6 month follow-up
measure: Changes in smoking cue reactivity related skin conductance level
timeFrame: Differences from baseline to the 6 month follow-up
measure: Changes in Theta and Alpha band power during smoking cue exposure
timeFrame: Differences from baseline to the 6 month follow-up
measure: Changes in heartbeat-evoked potential during smoking cue exposure
timeFrame: Differences from baseline to the 6 month follow-up
measure: Subjective ratings on the smoking self-efficacy scale
timeFrame: Differences from baseline to the 6 month follow-up
measure: Number of daily smoked cigarettes after smoking cessation
timeFrame: Time Frame: Differences from smoking cessation to the 6 month follow-up
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Württemberg
city: Regensburg
country: Germany
facility: University Regensburg
Study officials:
References: