<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02205060</url>
  </required_header>
  <id_info>
    <org_study_id>2013-A01253-42</org_study_id>
    <nct_id>NCT02205060</nct_id>
  </id_info>
  <brief_title>Virtual Reality Cue Exposurefor the Relapse Prevention of Tobacco Consumption</brief_title>
  <official_title>Interventionnal and Randomized Study Measuring Virtual Reality Cue Exposure for the Relapse Prevention of Tobacco Consumption Versus Cognitive and Behavioral Approaches Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The therapeutic efficacy of virtual reality has been validated for the treatment of various&#xD;
      mental disorders ,smoking behavior is the first preventable cause of death in developed&#xD;
      countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has&#xD;
      been observed, which emphasize the urgent need to implement new strategies. Virtual reality&#xD;
      cue exposure for the relapse of tobacco consumption&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking behavior is the first preventable cause of death in developed countries&#xD;
      (World.Health.Organisation, 2009).It is reinforced by the nicotine found in cigarettes. This&#xD;
      compound is responsible for a notable dependence effect. As a result of mass consumption,&#xD;
      this subsequent addiction of tobacco is a psychiatric disorder that represents a significant&#xD;
      public health issue. In France, the latest health survey INEPS (2010) retrieved an increase&#xD;
      of daily smokers with a prevalence of 28.7% among adults over 15 years (Beck et al., 2010).&#xD;
      However, after a successful withdrawal, a high relapse rate (between 40 and 70%) (Hatsukami&#xD;
      et al., 2008) has been observed, which emphasize the urgent need to implement new strategies.&#xD;
      These relapses are due to the presence of conditions associated with tobacco consumption&#xD;
      (drinking in bars or restaurant, coffee break at the workplace, etc.). (Garcia-Rodriguez et&#xD;
      al., 2012). These same situations are difficult to reconstruct in the framework of a hospital&#xD;
      or an office.&#xD;
&#xD;
      Virtual reality has been introduced in the field of psychiatry as a method entitled virtual&#xD;
      reality exposure therapy (VRET). Virtual reality allows patients to interact with a virtual&#xD;
      environment (Riva and Wiederhold, 2002). This media can therefore help to generate synthetic&#xD;
      environments which represent risk situations for the patient in the context of relapse&#xD;
      prevention.&#xD;
&#xD;
      The therapeutic efficacy of virtual reality has been validated for the treatment of various&#xD;
      mental disorders (phobias, agoraphobia and post-traumatic stress, etc.) (Powers and&#xD;
      Emmelkamp, 2008). These studies have shown that VRET was at least as effective as traditional&#xD;
      CBT while providing immersive and controllable virtual environments. During the recent years,&#xD;
      its scope has expanded to tobacco addiction (Garcia-Rodriguez et al., 2012), although this&#xD;
      area of research remains in experimental field and requires carrying out ad-hoc clinical&#xD;
      trials. Indeed, compared to the standard treatment, VRET offers various advantages for cue&#xD;
      exposure, such as controlled environments and complex, dynamic interactive three-dimensional&#xD;
      situations (virtual Bars, office and artificial smokers computerized restaurants, etc.). It&#xD;
      features the possibility of gradually exposing the patient to situations considered to be of&#xD;
      a &quot;high risk of relapse&quot; in the confidentiality of an office and repeating these procedures&#xD;
      as often as necessary. Lastly it allows the therapist to guide the patient in real time&#xD;
      helping them to modify emotions and addiction related cognitions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2014</start_date>
  <completion_date type="Actual">May 23, 2023</completion_date>
  <primary_completion_date type="Actual">September 26, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>evaluate the abstinence of tobacco consumption</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome measure is represented by the efficiency which will be defined in success / failure. The success is estimated at 6 months, from the abstinence of the patient. The abstinence is defined by the total absence of tobacco consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>assess the impact of this treatment strategy on depression</measure>
    <time_frame>12 months</time_frame>
    <description>depression wil be assess by Beck Depression Inventory - BDI scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>assess the impact of this treatment strategy on quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>quality of life will be assess by SF 12 questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Tabagism</condition>
  <arm_group>
    <arm_group_label>virtual reality exposure therapy (VRET)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>cognitive and behavioral approaches therapy without VRET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>virtual reality exposure treatment</intervention_name>
    <arm_group_label>virtual reality exposure therapy (VRET)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cognitive and behavioral approaches therapy</intervention_name>
    <arm_group_label>cognitive and behavioral approaches therapy without VRET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smoking withdrawal for at least 1 week&#xD;
&#xD;
          -  Age more than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Psychiatic desease&#xD;
&#xD;
          -  Dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Malbos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02205060
org study id: 2013-A01253-42
nct id: NCT02205060
lead sponsor: 
has dmc: No
The therapeutic efficacy of virtual reality has been validated for the treatment of various
      mental disorders ,smoking behavior is the first preventable cause of death in developed
      countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has
      been observed, which emphasize the urgent need to implement new strategies. Virtual reality
      cue exposure for the relapse of tobacco consumption
Smoking behavior is the first preventable cause of death in developed countries
      (World.Health.Organisation, 2009).It is reinforced by the nicotine found in cigarettes. This
      compound is responsible for a notable dependence effect. As a result of mass consumption,
      this subsequent addiction of tobacco is a psychiatric disorder that represents a significant
      public health issue. In France, the latest health survey INEPS (2010) retrieved an increase
      of daily smokers with a prevalence of 28.7% among adults over 15 years (Beck et al., 2010).
      However, after a successful withdrawal, a high relapse rate (between 40 and 70%) (Hatsukami
      et al., 2008) has been observed, which emphasize the urgent need to implement new strategies.
      These relapses are due to the presence of conditions associated with tobacco consumption
      (drinking in bars or restaurant, coffee break at the workplace, etc.). (Garcia-Rodriguez et
      al., 2012). These same situations are difficult to reconstruct in the framework of a hospital
      or an office.

      Virtual reality has been introduced in the field of psychiatry as a method entitled virtual
      reality exposure therapy (VRET). Virtual reality allows patients to interact with a virtual
      environment (Riva and Wiederhold, 2002). This media can therefore help to generate synthetic
      environments which represent risk situations for the patient in the context of relapse
      prevention.

      The therapeutic efficacy of virtual reality has been validated for the treatment of various
      mental disorders (phobias, agoraphobia and post-traumatic stress, etc.) (Powers and
      Emmelkamp, 2008). These studies have shown that VRET was at least as effective as traditional
      CBT while providing immersive and controllable virtual environments. During the recent years,
      its scope has expanded to tobacco addiction (Garcia-Rodriguez et al., 2012), although this
      area of research remains in experimental field and requires carrying out ad-hoc clinical
      trials. Indeed, compared to the standard treatment, VRET offers various advantages for cue
      exposure, such as controlled environments and complex, dynamic interactive three-dimensional
      situations (virtual Bars, office and artificial smokers computerized restaurants, etc.). It
      features the possibility of gradually exposing the patient to situations considered to be of
      a "high risk of relapse" in the confidentiality of an office and repeating these procedures
      as often as necessary. Lastly it allows the therapist to guide the patient in real time
      helping them to modify emotions and addiction related cognitions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: evaluate the abstinence of tobacco consumption
time frame: 12 months
description: The primary outcome measure is represented by the efficiency which will be defined in success / failure. The success is estimated at 6 months, from the abstinence of the patient. The abstinence is defined by the total absence of tobacco consumption
measure: assess the impact of this treatment strategy on depression
time frame: 12 months
description: depression wil be assess by Beck Depression Inventory - BDI scale
measure: assess the impact of this treatment strategy on quality of life
time frame: 12 months
description: quality of life will be assess by SF 12 questionnaire
arm group label: virtual reality exposure therapy (VRET)
arm group type: Experimental
arm group label: cognitive and behavioral approaches therapy without VRET
arm group type: Experimental
intervention type: Other
intervention name: virtual reality exposure treatment
arm group label: virtual reality exposure therapy (VRET)
intervention type: Other
intervention name: cognitive and behavioral approaches therapy
arm group label: cognitive and behavioral approaches therapy without VRET
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eric Malbos, MD
role: Principal Investigator
affiliation: Assistance Publique Hopitaux De Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Recurrence