<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/NCT03813264</url>
  </required_header>
  <id_info>
    <org_study_id>SHA-0013-18</org_study_id>
    <nct_id>NCT03813264</nct_id>
  </id_info>
  <brief_title>Optimizing Outcomes of Dynamic Psychotherapy by the MATRIX: A Preliminary Study</brief_title>
  <official_title>Optimizing Outcomes of Dynamic Psychotherapy by the MATRIX: A Preliminary Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shalvata Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shalvata Mental Health Center</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>
      Mental disorders require therapeutic effort that contains drug components and&#xD;
      psychotherapeutic intervention. The latter requires many resources in light of the skill&#xD;
      required. Moreover, such intervention is long, and it takes a long time to assess its&#xD;
      effectiveness. The proposed study seeks to implement a management system (ie, a system that&#xD;
      monitors and intervenes in ineffective and even harmful treatments) for the purpose of&#xD;
      optimizing psychotherapies. The system monitors the improvement in patients' condition in&#xD;
      treatment using a mobile phone-based system, and when the treatment is ineffective, it&#xD;
      recommends correction strategies. The study will help reduce the ineffective or harmful&#xD;
      treatment in dynamic psychotherapy, increasing the quality of care the patient receives. And&#xD;
      will lead to the optimal utilization of resources in the mental health system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the proposed study is to examine, on a preliminary basis, the feasibility of a&#xD;
      monitoring and intervention system that will enable the identification and even improvement&#xD;
      of ineffective (and even harmful) hours of therapy in dynamic psychotherapy.&#xD;
&#xD;
      The study will take place in the clinic complex located at the Shalvata Mental Health Center&#xD;
      campus (Shalva clinic, departmental follow-up clinics, day department), and will include 10&#xD;
      therapists (psychiatrists, psychologists, social workers) and 10 patients.The duration of the&#xD;
      study will be two months. Once the patient and the therapist have signed an informed consent&#xD;
      form, they will be integrated into a cellular-based routine outcome monitoring (ROM) that is&#xD;
      developed specifically for the present study. This system, which is completely separate from&#xD;
      the clinical systems of the Center, is operated after each session by the therapist. Its&#xD;
      activation sends an SMS to the patient and to the therapist, in which a referral to a&#xD;
      designated and secure site in which questionnaires are administered in order to measure the&#xD;
      patient's condition and the assessment of the therapist and the patient regarding the quality&#xD;
      of the therapeutic session. In addition, during the entire study period, the hours of&#xD;
      treatment will be recorded in a dedicated manual recording device. This is done routinely in&#xD;
      many research institutes in Israel and around the world, with the aim of approving the&#xD;
      analysis of inefficient or harmful treatment hours. Treatment hours based on ROM data that&#xD;
      have a negative effect (ie, evaluated negatively by the patient) will be transcribed by the&#xD;
      therapist, and will undergo full MATRIX analysis. In each treatment pair, an analysis of up&#xD;
      to two hours will be possible throughout the four months of the study. This analysis includes&#xD;
      the conversion of the text to MATRIX codes, 3-letter codes that mark the section speaker&#xD;
      (patient or therapist), the subject of the section (patient, therapist, or both) and its&#xD;
      character (whether it deals with the ability to experience [ , Or the relationship between&#xD;
      experiences [interrelation]). The coding will be performed by the principal investigator or&#xD;
      by the secondary investigator. After the encoding analysis, a MATRIX-based feedback will be&#xD;
      given by the Principal Investigator to the therapist, in which the recommendations of the&#xD;
      analysis will be submitted.&#xD;
&#xD;
      The proposed study combines routine conventional follow-up practices (ROM) in psychotherapy&#xD;
      with innovative analysis tools (MATRIX), and seeks to be a first and significant step in&#xD;
      addressing the urgent need to implement managed care in psychotherapy. This has far-reaching&#xD;
      implications for the management of mental health care in community, clinic, day care and&#xD;
      hospitalization units.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The proposed study consists of two complementary processes: the first is the routine collection of clinical data using ROM; The second process is MATRIX-based intervention that is expected to improve the course of treatment.&#xD;
The study will take place in the clinic complex located at the Shalvata Mental Health Center campus (Shalva clinic, departmental follow-up clinics, day department), and will include 10 therapists (psychiatrists, psychologists, social workers) and 10 patients.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implementation of patient/therapist mobile phone based routine monitoring tools in public psychiatric services.</measure>
    <time_frame>12 months</time_frame>
    <description>high adherence rate of routine mobile based measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>efficiency of a platform that combine monitor and intervene clinical practice</measure>
    <time_frame>12 months</time_frame>
    <description>outcome of psychotherapeutic treatments based on the collection of routine outcomes [ROM] and analysis of MATRIX as measured by the OQ-45 (the most common outcome questionnaire in psychotherapy).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Psychotherapy</condition>
  <condition>Mental Health</condition>
  <condition>Monitoring</condition>
  <arm_group>
    <arm_group_label>preliminary arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pairs of patients and their therapists</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine outcome measures (ROM)</intervention_name>
    <description>The proposed study consists of two complementary processes: the first is the routine collection of clinical data using ROM; The second process is MATRIX-based intervention that is expected to improve the course of treatment.</description>
    <arm_group_label>preliminary arm</arm_group_label>
    <other_name>MATRIX (a tool for analysis of therapeutic hours)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects (patients / therapists) over the age of 18.&#xD;
&#xD;
          -  had agreed to participate in the study.&#xD;
&#xD;
          -  eligible for psychotherapeutic treatment.&#xD;
&#xD;
          -  treated with the attending clinician for at least two months.&#xD;
&#xD;
          -  treated/treating with dynamic psychotherapeutic treatment only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who (due to cognitive impairment, language gaps, etc.) are unable to complete&#xD;
             a questionnaire with little help.&#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_contact>
    <last_name>Shlomo Mendlovich, MD</last_name>
    <phone>+972506770178</phone>
    <email>mendlovich@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hanna Lanchinsky, Mrs</last_name>
    <phone>+97297478644</phone>
    <email>hanaln@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shalvata Mental Health center</name>
      <address>
        <city>Hod Hasharon,</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shalvata Mental Health Center</investigator_affiliation>
    <investigator_full_name>Shlomo Mendlovich</investigator_full_name>
    <investigator_title>director of the Shalvata Mental Health Center</investigator_title>
  </responsible_party>
  <keyword>MATRIX</keyword>
  <keyword>ROM (Routine Outcome Measures)</keyword>
  <keyword>mobile-assisted PROMS</keyword>
  <keyword>managed care</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03813264
org study id: SHA-0013-18
nct id: NCT03813264
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mental disorders require therapeutic effort that contains drug components and
      psychotherapeutic intervention. The latter requires many resources in light of the skill
      required. Moreover, such intervention is long, and it takes a long time to assess its
      effectiveness. The proposed study seeks to implement a management system (ie, a system that
      monitors and intervenes in ineffective and even harmful treatments) for the purpose of
      optimizing psychotherapies. The system monitors the improvement in patients' condition in
      treatment using a mobile phone-based system, and when the treatment is ineffective, it
      recommends correction strategies. The study will help reduce the ineffective or harmful
      treatment in dynamic psychotherapy, increasing the quality of care the patient receives. And
      will lead to the optimal utilization of resources in the mental health system.
The purpose of the proposed study is to examine, on a preliminary basis, the feasibility of a
      monitoring and intervention system that will enable the identification and even improvement
      of ineffective (and even harmful) hours of therapy in dynamic psychotherapy.

      The study will take place in the clinic complex located at the Shalvata Mental Health Center
      campus (Shalva clinic, departmental follow-up clinics, day department), and will include 10
      therapists (psychiatrists, psychologists, social workers) and 10 patients.The duration of the
      study will be two months. Once the patient and the therapist have signed an informed consent
      form, they will be integrated into a cellular-based routine outcome monitoring (ROM) that is
      developed specifically for the present study. This system, which is completely separate from
      the clinical systems of the Center, is operated after each session by the therapist. Its
      activation sends an SMS to the patient and to the therapist, in which a referral to a
      designated and secure site in which questionnaires are administered in order to measure the
      patient's condition and the assessment of the therapist and the patient regarding the quality
      of the therapeutic session. In addition, during the entire study period, the hours of
      treatment will be recorded in a dedicated manual recording device. This is done routinely in
      many research institutes in Israel and around the world, with the aim of approving the
      analysis of inefficient or harmful treatment hours. Treatment hours based on ROM data that
      have a negative effect (ie, evaluated negatively by the patient) will be transcribed by the
      therapist, and will undergo full MATRIX analysis. In each treatment pair, an analysis of up
      to two hours will be possible throughout the four months of the study. This analysis includes
      the conversion of the text to MATRIX codes, 3-letter codes that mark the section speaker
      (patient or therapist), the subject of the section (patient, therapist, or both) and its
      character (whether it deals with the ability to experience [ , Or the relationship between
      experiences [interrelation]). The coding will be performed by the principal investigator or
      by the secondary investigator. After the encoding analysis, a MATRIX-based feedback will be
      given by the Principal Investigator to the therapist, in which the recommendations of the
      analysis will be submitted.

      The proposed study combines routine conventional follow-up practices (ROM) in psychotherapy
      with innovative analysis tools (MATRIX), and seeks to be a first and significant step in
      addressing the urgent need to implement managed care in psychotherapy. This has far-reaching
      implications for the management of mental health care in community, clinic, day care and
      hospitalization units.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The proposed study consists of two complementary processes: the first is the routine collection of clinical data using ROM; The second process is MATRIX-based intervention that is expected to improve the course of treatment.
The study will take place in the clinic complex located at the Shalvata Mental Health Center campus (Shalva clinic, departmental follow-up clinics, day department), and will include 10 therapists (psychiatrists, psychologists, social workers) and 10 patients.
primary purpose: Health Services Research
masking: None (Open Label)
measure: implementation of patient/therapist mobile phone based routine monitoring tools in public psychiatric services.
time frame: 12 months
description: high adherence rate of routine mobile based measures
measure: efficiency of a platform that combine monitor and intervene clinical practice
time frame: 12 months
description: outcome of psychotherapeutic treatments based on the collection of routine outcomes [ROM] and analysis of MATRIX as measured by the OQ-45 (the most common outcome questionnaire in psychotherapy).
arm group label: preliminary arm
arm group type: Experimental
description: pairs of patients and their therapists
intervention type: Other
intervention name: Routine outcome measures (ROM)
description: The proposed study consists of two complementary processes: the first is the routine collection of clinical data using ROM; The second process is MATRIX-based intervention that is expected to improve the course of treatment.
arm group label: preliminary arm
other name: MATRIX (a tool for analysis of therapeutic hours)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shlomo Mendlovich, MD
phone: +972506770178
email: mendlovich@clalit.org.il
last name: Hanna Lanchinsky, Mrs
phone: +97297478644
email: hanaln@clalit.org.il
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Shalvata Mental Health Center
investigator full name: Shlomo Mendlovich
investigator title: director of the Shalvata Mental Health Center
sharing ipd: No