Psychotropic Medication and Psychotherapeutic Treatment of Adults With Intellectual Disabilities

NCT ID: NCT03558815

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-05-31

Brief Summary

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Mental health service provision of adults with intellectual disabilities (ID) is often criticized. There is a lack of empirically studies targeting the psychotropic and psychotherapeutic treatment in this population. The PROMPT-ID study therefore aims to assess the prevalence of psychotropic medication and psychotherapeutic treatment in adults with mild to profound ID and the quality of psychotropic medication. It further aims to identify predictors of psychotropic medication, of barriers into psychotherapeutic treatment and of good clinical psychotropic medication prescription practice. It is a cross-sectional, epidemiological study carried out in Saxony, Germany. Approval of the responsible ethics committee was obtained. The inclusion criteria are mild to profound forms of ID and an age of 18 years or older. A representative sample is realized by a two-stage sampling procedure. Sheltered working and accommodation service providers are stratified by type of service provider and workshop size/type of accommodation. The stratified cluster sampling is realized by a random selection of service providing institutions followed by a random selection of adults with ID. An estimated total number of n = 200 study participants via sheltered workshops and n = 400 via residential accommodations need to be contacted to obtain data of approximately n = 131 study participants recruited through sheltered workshops and n = 232 participants through sheltered living institutions. Based on a psychotropic medication prevalence of 30%, in- depth interviews about psychotropic prescription practice of an estimated number of n = 109 adults with ID are carried out. Data collection is realized in interviews with key carers in the living environment and, if applicable, with the prescribing physician. If the adults with ID are currently medicated with psychotropics, basic information e.g. about kind, agent, dosage and treatment duration are obtained and a newly developed interview targeting the quality of the psychotropic medication treatment is conducted with the carers. In addition to the prevalence and quality of psychotropic and psychotherapeutic health care utilisation, other parameters like psychiatric symptomatology, problem behavior, sociodemografic and institutional factors and parameters of the provision area are assessed using well- established instruments. Findings will fill the lack of representative data that is urgently needed in this often criticized health service area.

Detailed Description

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Conditions

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Intellectual Disability

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adults with mild, moderate, severe or profound ID

Adults with mild, moderate, severe or profound ID in contact with either a sheltered workshop and/ or sheltered living Institution in Saxony.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Mild to profound levels of ID
* Age of 18 years or older

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Matthias Schützwohl

Head of Mental Health Services Research Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Schützwohl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychoptherapy

Locations

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Department of psychiatry and Psychotherapy

Dresden, , Germany

Site Status

Countries

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Germany

References

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Koch A, Dobrindt J, Schutzwohl M. Psychotropic medication and psychotherapeutic treatment of adults with intellectual disabilities (PROMPT-ID): a cross-sectional, epidemiological study in Saxony, Germany. BMJ Open. 2018 Dec 19;8(12):e025947. doi: 10.1136/bmjopen-2018-025947.

Reference Type DERIVED
PMID: 30573492 (View on PubMed)

Other Identifiers

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040_5121

Identifier Type: -

Identifier Source: org_study_id

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