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Completed

NCT Number: NCT03707106

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen, Tübingen, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT smoking cessation

Behavioral

an established protocol for smoking cessation based on cognitive behavioral therapy

virtual reality based cue exposure

Behavioral

smoking cue exposure in virtual reality

Progressive Muscle Relaxation

Behavioral

Progressive muscle relaxation for unspecific stress reduction

Primary outcomes

  1. Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment

    Time frame: 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 outcomes

  1. Changes in smoking cue event-related potentials (ERP: LPP)

    Time frame: Differences from baseline to the 6 month follow-up

    late positive potential (LPP) amplitude (Microvolts)

  2. Changes in smoking cue event-related potentials (ERP:P3)

    Time frame: Differences from baseline to the 6 month follow-up

    P3 amplitude (Microvolts) during avoidance of smoking cues

  3. Changes in approach tendency to smoking pictures

    Time frame: 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.

  4. Changes in smoking cue reactivity related skin conductance level

    Time frame: Differences from baseline to the 6 month follow-up

    Differences in conductance level (MicroSiemens) during smoking cue exposure and exposure to a neutral cue.

  5. Changes in Theta and Alpha band power during smoking cue exposure

    Time frame: Differences from baseline to the 6 month follow-up

    Differences in Alpha and Theta band power during smoking cue exposure and neutral cue exposure.

  6. Changes in heartbeat-evoked potential during smoking cue exposure

    Time frame: Differences from baseline to the 6 month follow-up

    Amplitude (microvolts) of heartbeat-evoked potential

  7. Subjective ratings on the smoking self-efficacy scale

    Time frame: 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)

  8. Number of daily smoked cigarettes after smoking cessation

    Time frame: Time Frame: Differences from smoking cessation to the 6 month follow-up

    Sum of self-reported smoked cigarettes after smoking cessation

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • University of Regensburg

Registry information

Official study 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

Acronym: ViReTa

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 16, 2018
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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