<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/NCT01695395</url>
  </required_header>
  <id_info>
    <org_study_id>BMBF-01GY1134</org_study_id>
    <nct_id>NCT01695395</nct_id>
  </id_info>
  <brief_title>Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder</brief_title>
  <acronym>MEMENTA</acronym>
  <official_title>Mental Health Care Provision for Adults With Mental Retardation and a Psychiatric Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quality of mental health services provision for adults with intellectual disability and&#xD;
      comorbid mental disorder is considered inadequate and therefore in need of further&#xD;
      improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study&#xD;
      therefore aims to compare mild and moderate intellectual disabled adults with a comorbid&#xD;
      mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid&#xD;
      mental disorder with respect to clinical parameters. The MEMENTA-study is an observational,&#xD;
      epidemiological, cross-sectional study. A representative sample of the target population is&#xD;
      realised by the assessment of approximately n=600 intellectual disabled adults working at&#xD;
      specialized facilities (sheltered workshops). A cluster sampling with probability&#xD;
      proportional to institution and size (n of overall employed persons) will be followed by a&#xD;
      simple random sampling of persons of these clustered facilities. A number of parameters such&#xD;
      as severity of mental health impairment, needs for care, quality of life (QoL), caregiver&#xD;
      burden, health services utilization, and costs for care will be assessed by using a set of&#xD;
      well-established standardised instruments. Quality of mental health care will be assessed and&#xD;
      examined by open questions to intellectual disabled adults with a comorbid mental disorder as&#xD;
      well as informal caregivers and staff of caring institutions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mental Health status</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">371</enrollment>
  <condition>Mental Disorder</condition>
  <condition>Intellectual Disability</condition>
  <arm_group>
    <arm_group_label>Intellectual disabled adults without a mental disorder</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Intellectual disabled adults with a mental disorder</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population are adults with mild or moderate intellectual disability.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild or moderate intellectual disability&#xD;
&#xD;
          -  adults aged between 18-65 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Schützwohl, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>TU Dresden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Psychiatric Health Service Research Group, Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01219</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Institute of Mental Health</name>
      <address>
        <city>Mannheim</city>
        <zip>68159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mental Health Services RU, Department of Psychiatry II, Ulm University</name>
      <address>
        <city>Ulm</city>
        <zip>89073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>February 10, 2015</last_update_submitted>
  <last_update_submitted_qc>February 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technische Universität Dresden</investigator_affiliation>
    <investigator_full_name>Dr. Matthias Schützwohl</investigator_full_name>
    <investigator_title>PD</investigator_title>
  </responsible_party>
  <keyword>intellectual disability</keyword>
  <keyword>mental disorder</keyword>
  <keyword>dual diagnosis</keyword>
  <keyword>provision</keyword>
  <keyword>needs assessment</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</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/NCT01695395
org study id: BMBF-01GY1134
nct id: NCT01695395
lead sponsor: 
collaborator: 
has dmc: Yes
Quality of mental health services provision for adults with intellectual disability and
      comorbid mental disorder is considered inadequate and therefore in need of further
      improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study
      therefore aims to compare mild and moderate intellectual disabled adults with a comorbid
      mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid
      mental disorder with respect to clinical parameters. The MEMENTA-study is an observational,
      epidemiological, cross-sectional study. A representative sample of the target population is
      realised by the assessment of approximately n=600 intellectual disabled adults working at
      specialized facilities (sheltered workshops). A cluster sampling with probability
      proportional to institution and size (n of overall employed persons) will be followed by a
      simple random sampling of persons of these clustered facilities. A number of parameters such
      as severity of mental health impairment, needs for care, quality of life (QoL), caregiver
      burden, health services utilization, and costs for care will be assessed by using a set of
      well-established standardised instruments. Quality of mental health care will be assessed and
      examined by open questions to intellectual disabled adults with a comorbid mental disorder as
      well as informal caregivers and staff of caring institutions.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Mental Health status
time frame: baseline
arm group label: Intellectual disabled adults without a mental disorder
arm group label: Intellectual disabled adults with a mental disorder
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Matthias Schützwohl, PD Dr.
role: Principal Investigator
affiliation: TU Dresden
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technische Universität Dresden
investigator full name: Dr. Matthias Schützwohl
investigator title: PD
mesh term: Intellectual Disability
mesh term: Mental Disorders
mesh term: Psychotic Disorders