Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-13 @ 2:28 PM
Study NCT ID:
NCT01695395
Status:
COMPLETED
Last Update Posted:
2015-02-11
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008607', 'term': 'Intellectual Disability'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2012-09-26', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental Health status', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intellectual disability', 'mental disorder', 'dual diagnosis', 'provision', 'needs assessment', 'quality of life'], 'conditions': ['Mental Disorder', 'Intellectual Disability']}, 'referencesModule': {'references': [{'pmid': '24844270', 'type': 'DERIVED', 'citation': "Koch A, Vogel A, Holzmann M, Pfennig A, Salize HJ, Puschner B, Schutzwohl M. MEMENTA-'Mental healthcare provision for adults with intellectual disability and a mental disorder'. A cross-sectional epidemiological multisite study assessing prevalence of psychiatric symptomatology, needs for care and quality of healthcare provision for adults with intellectual disability in Germany: a study protocol. BMJ Open. 2014 May 20;4(5):e004878. doi: 10.1136/bmjopen-2014-004878."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population are adults with mild or moderate intellectual disability.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild or moderate intellectual disability\n* adults aged between 18-65 years'}, 'identificationModule': {'nctId': 'NCT01695395', 'acronym': 'MEMENTA', 'briefTitle': 'Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Mental Health Care Provision for Adults With Mental Retardation and a Psychiatric Diagnosis', 'orgStudyIdInfo': {'id': 'BMBF-01GY1134'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intellectual disabled adults without a mental disorder'}, {'label': 'Intellectual disabled adults with a mental disorder'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01219', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Psychiatric Health Service Research Group, Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '68159', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Central Institute of Mental Health', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '89073', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Mental Health Services RU, Department of Psychiatry II, Ulm University', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Matthias Schützwohl, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TU Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD', 'investigatorFullName': 'Dr. Matthias Schützwohl', 'investigatorAffiliation': 'Technische Universität Dresden'}}}}