xml: <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/NCT05964296</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/21/0540</org_study_id>
      <nct_id>NCT05964296</nct_id>
    </id_info>
    <brief_title>The Impact of the Use of the MAURISSE Application in People Suffering From an Addiction.</brief_title>
    <acronym>ALMA</acronym>
    <official_title>Study of Impact on Therapeutic Alliance in People With Addiction Using the MAURISSE Application.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care&#xD;
        attrition and mistrust towards care. Considering this, establishing a strong, trustful&#xD;
        relationship between the patient and the healthcare team is important to promote patient&#xD;
        engagement within SUD management. However, it requires an important availability of the&#xD;
        healthcare team, allowing for frequent interactions at all times, including at night and&#xD;
        during days off. We postulated that a mobile application called MAURISSE, which aims to help&#xD;
        the caregivers maintaining a link with the patient in order to facilitate trust in the&#xD;
        relationship, could foster patient engagement as well as the therapeutic alliance.&#xD;
  &#xD;
        This research aims to compare the effect of the application MAURISSE on the therapeutic&#xD;
        alliance in a population of patients treated for a disorder related to substance use at the&#xD;
        Toulouse University Hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Substance Use Disorders (SUD) are frequently associated with other mental disorders,&#xD;
        especially Borderline Personality Disorder, thus defining co-occurring substance use and&#xD;
        mental disorders with borderline and anti-social personality disorders that is often&#xD;
        associated with cognitive schemas leading to care attrition and mistrust towards care. The&#xD;
        goal of the care intervention within Substance Use Disorders management is therefore to help&#xD;
        the patient reduce the use of dysfunctional coping strategies involving substance use.&#xD;
        Indeed, the establishment of a trustful relation between the patient and the care team leads&#xD;
        the patient into building a secure attachment towards care that could secondly be generalized&#xD;
        in other situations. We designed an application called MAURISSE, which aims to help the&#xD;
        caregivers maintaining a link with the patient in order to facilitate a more secure&#xD;
        attachment, thus enabling trust in the relationship as well as fostering patient engagement&#xD;
        in the care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The therapeutic alliance score assessed by the Working Alliance Inventory Short Revised scale (WAI-SR).</measure>
      <time_frame>2 months</time_frame>
      <description>The Working Alliance Inventory-Short Revised is a scale that consists of two questionnaires. A 12-question questionnaire for patients and a 10-question questionnaire for caregivers. The questions are scored using a Likert scale ranging from 1 to 5</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Substance Related Disorder</condition>
    <condition>Personality Disorders</condition>
    <arm_group>
      <arm_group_label>Application group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized to the digital application arm will benefit from treatment as usual and will have access to the MAURISSE application, allowing them to communicate with the healthcare team using a messaging system, to report and follow substance use, to access a To-do list, to access personal multimedia contents helping with the treatment, to report a feeling of boredom (these moments presenting a risk of relapse) and finally to access a list of propositions in order to fight this feeling</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard-of-care group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>These patients will benefit from the usual care within the center (appointments with doctors; regular follow-up meetings with nurses, psychologists, social workers, therapeutic groups depending on the evaluation).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The MAURISSE application use</intervention_name>
      <description>Exchanges with the care team via the messaging system,&#xD;
  Postponement of consumption,&#xD;
  Monitoring of consumption,&#xD;
  Access to information on the To Do List,&#xD;
  Access to personal content to help with management (Socio-professional situation, type of life, personal history..).&#xD;
  Postponement of a feeling of boredom,&#xD;
  Access to proposals to fight against this feeling.</description>
      <arm_group_label>Application group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual care</intervention_name>
      <description>The usual care within the center will consist of appointments with doctors; regular follow-up meetings with nurses, psychologists, social workers, therapeutic groups depending on the evaluation.</description>
      <arm_group_label>Standard-of-care group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient over 18 years old,&#xD;
  &#xD;
            -  Starting specialized treatment for addiction (addiction to substance and behavioral&#xD;
               addiction too as money games addiction).&#xD;
  &#xD;
            -  Suffering from any type of addiction, with an active addiction requiring weekly&#xD;
               monitoring of substance use.&#xD;
  &#xD;
            -  possessing a smartphone or having access to a smartphone and having access to an&#xD;
               internet connection.&#xD;
  &#xD;
            -  Able to read and understand French.&#xD;
  &#xD;
            -  Affiliated or beneficiary of a social security scheme.&#xD;
  &#xD;
            -  Free, informed and written consent signed by the participant and the investigator (at&#xD;
               the latest on the day of inclusion and before any examination required by the&#xD;
               research).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with cognitive or psychiatric disorders that may affect their ability to&#xD;
               consent.&#xD;
  &#xD;
            -  Participation in another protocol involving a modification of the treatment for&#xD;
               addiction.&#xD;
  &#xD;
            -  Known or suspected pregnancy.&#xD;
  &#xD;
            -  Person under legal protection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Juliette SALLES</last_name>
      <role>Principal Investigator</role>
      <affiliation>Toulouse University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Juliette SALLES</last_name>
      <phone>05 61 77 73 07</phone>
      <email>salles.j@chu-toulouse.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nicolas NAVARRO</last_name>
      <email>navarro.ni@chu-toulouse.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital of Toulouse</name>
        <address>
          <city>Toulouse</city>
          <zip>31059</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Juliette SALLES</last_name>
        <email>salles.j@chu-toulouse.fr</email>
      </contact>
      <contact_backup>
        <last_name>Valérie MALLARD</last_name>
        <email>mallard.v@chu-toulouse.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Juliette SALLES</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nicolas NAVARRO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>eHealth</keyword>
    <keyword>mHealth</keyword>
    <keyword>application</keyword>
    <keyword>substance use disorders</keyword>
    <keyword>personality disorders</keyword>
    <keyword>care observance</keyword>
    <keyword>therapeutic alliance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
      <mesh_term>Personality Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964296
  org study id: RC31/21/0540
  nct id: NCT05964296
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care
        attrition and mistrust towards care. Considering this, establishing a strong, trustful
        relationship between the patient and the healthcare team is important to promote patient
        engagement within SUD management. However, it requires an important availability of the
        healthcare team, allowing for frequent interactions at all times, including at night and
        during days off. We postulated that a mobile application called MAURISSE, which aims to help
        the caregivers maintaining a link with the patient in order to facilitate trust in the
        relationship, could foster patient engagement as well as the therapeutic alliance.
  
        This research aims to compare the effect of the application MAURISSE on the therapeutic
        alliance in a population of patients treated for a disorder related to substance use at the
        Toulouse University Hospital.
  Substance Use Disorders (SUD) are frequently associated with other mental disorders,
        especially Borderline Personality Disorder, thus defining co-occurring substance use and
        mental disorders with borderline and anti-social personality disorders that is often
        associated with cognitive schemas leading to care attrition and mistrust towards care. The
        goal of the care intervention within Substance Use Disorders management is therefore to help
        the patient reduce the use of dysfunctional coping strategies involving substance use.
        Indeed, the establishment of a trustful relation between the patient and the care team leads
        the patient into building a secure attachment towards care that could secondly be generalized
        in other situations. We designed an application called MAURISSE, which aims to help the
        caregivers maintaining a link with the patient in order to facilitate a more secure
        attachment, thus enabling trust in the relationship as well as fostering patient engagement
        in the care.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: The therapeutic alliance score assessed by the Working Alliance Inventory Short Revised scale (WAI-SR).
  time frame: 2 months
  description: The Working Alliance Inventory-Short Revised is a scale that consists of two questionnaires. A 12-question questionnaire for patients and a 10-question questionnaire for caregivers. The questions are scored using a Likert scale ranging from 1 to 5
  arm group label: Application group
  arm group type: Experimental
  description: Patients randomized to the digital application arm will benefit from treatment as usual and will have access to the MAURISSE application, allowing them to communicate with the healthcare team using a messaging system, to report and follow substance use, to access a To-do list, to access personal multimedia contents helping with the treatment, to report a feeling of boredom (these moments presenting a risk of relapse) and finally to access a list of propositions in order to fight this feeling
  arm group label: Standard-of-care group
  arm group type: Active Comparator
  description: These patients will benefit from the usual care within the center (appointments with doctors; regular follow-up meetings with nurses, psychologists, social workers, therapeutic groups depending on the evaluation).
  intervention type: Other
  intervention name: The MAURISSE application use
  description: Exchanges with the care team via the messaging system,
  Postponement of consumption,
  Monitoring of consumption,
  Access to information on the To Do List,
  Access to personal content to help with management (Socio-professional situation, type of life, personal history..).
  Postponement of a feeling of boredom,
  Access to proposals to fight against this feeling.
  arm group label: Application group
  intervention type: Other
  intervention name: Usual care
  description: The usual care within the center will consist of appointments with doctors; regular follow-up meetings with nurses, psychologists, social workers, therapeutic groups depending on the evaluation.
  arm group label: Standard-of-care group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Juliette SALLES
  role: Principal Investigator
  affiliation: Toulouse University Hospital
  last name: Juliette SALLES
  phone: 05 61 77 73 07
  email: salles.j@chu-toulouse.fr
  last name: Nicolas NAVARRO
  email: navarro.ni@chu-toulouse.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Substance-Related Disorders
  mesh term: Personality Disorders