Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707106
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
University of Regensburg
Information provided by (Responsible Party):
Anil Batra, University Hospital Tuebingen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: CBT smoking cessation Behavioral: virtual reality based cue exposure Behavioral: progressive muscle relaxation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: VR based cue exposure smoking cessation
an established CBT intervention for smoking cessation supported by cue exposure in virtual reality
 Behavioral: CBT smoking cessation
an established protocol for smoking cessation based on cognitive behavioral therapy

Behavioral: virtual reality based cue exposure
smoking cue exposure in virtual reality
Active Comparator: PMR supported smoking cessation
an established CBT intervention for smoking cessation supported supported by specific stress reduction (Progressive Muscle Relaxation, Jacobson)
 Behavioral: CBT smoking cessation
an established protocol for smoking cessation based on cognitive behavioral therapy

Behavioral: progressive muscle relaxation
Progressive muscle relaxation for unspecific stress reduction


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707106


Contacts
Layout table for location contacts
Contact: Agnes Kroczek +497071 2987103 agnes.kroczek@med.uni-tuebingen.de

Locations
Layout table for location information
Germany
University Hospital Tuebingen Enrolling by invitation
Tuebingen, Baden-Württemberg, Germany, 72076
University Regensburg Recruiting
Regensburg, Germany
Contact: Benedikt Amberger         
Sponsors and Collaborators
University Hospital Tuebingen
University of Regensburg
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Anil Batra, Deputy Head of Psychiatry, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03707106    
Other Study ID Numbers: 70111871
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anil Batra, University Hospital Tuebingen:
virtual reality
cue exposure
progressive muscle relaxation