Mental DisorderMEMENTANCT01695395
Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder
An observational study of Mental Disorder and Intellectual Disability, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorder, Intellectual Disability
- How many people
- 371 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population are adults with mild or moderate intellectual disability.
Who may be able to join
- mild or moderate intellectual disability
- adults aged between 18-65 years
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Psychiatric Health Service Research Group, Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital
Dresden, Saxony, 01219
Central Institute of Mental Health
Mannheim, 68159
Mental Health Services RU, Department of Psychiatry II, Ulm University
Ulm, 89073
About this study
Official title: Mental Health Care Provision for Adults With Mental Retardation and a Psychiatric Diagnosis
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.
- Conditions
- Mental Disorder, Intellectual Disability
- Keywords
- intellectual disability, mental disorder, dual diagnosis, provision, needs assessment, quality of life
- Medical subject headings
- Mental Disorders, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intellectual disabled adults without a mental disorder | Not described | |
| Intellectual disabled adults with a mental disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health status
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Dr. Matthias Schützwohl, Technische Universität Dresden
- Investigators
- Matthias Schützwohl, PD Dr., Principal investigator, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695395
- Sponsor's protocol ID
- BMBF-01GY1134
- Acronym
- MEMENTA
- Status last verified
- Feb 2015
- First submitted
- 26 Sep 2012
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24844270
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Care Provision for Adults With Mental Retardation and a Psychiatric Diagnosis
- ClinicalTrials.gov ID
- NCT01695395
- Acronym / sponsor ID
- MEMENTA / BMBF-01GY1134
- Conditions
- Mental Disorder, Intellectual Disability
- Keywords
- intellectual disability, mental disorder, dual diagnosis, provision, needs assessment, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intellectual disabled adults without a mental disorder | – | – |
| Intellectual disabled adults with a mental disorder | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are adults with mild or moderate intellectual disability.
Key inclusion criteria (2 listed)
- mild or moderate intellectual disability
- adults aged between 18-65 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mental Health status
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
- Derived from this study: PubMed 24844270Koch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Schützwohl, PD Dr. principal investigator
TU Dresden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder and Intellectual Disability, run by Technische Universität Dresden at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health status (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.