Psychiatric Disorders From Chapters 3 and 4 of ICD10INT_REF_MHNCT04832035
Integration of Refugees Into Public Mental Health Care
A study testing "coordinated and peer supported mental health care" and "standard psychotherapeutic care in the public healthcare system" in people with Psychiatric Disorders From Chapters 3 and 4 of ICD10, run by University of Konstanz at 1 site in Germany.
Trial summary
There are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the German public health care system. This study aims to evaluate additional organisational components that are hypothesised to improve service utilisation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psychiatric Disorders From Chapters 3 and 4 of ICD10
- What is being tested?
- "coordinated and peer supported mental health care" and "standard psychotherapeutic care in the public healthcare system"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 30 Jun 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Psychiatric diagnosis from Chapters 3 and 4 of ICD10
- Participant applied for asylum in Germany
- Entry to Germany after 2012
- Participants is motivated to utilise psychotherapeutic services
- Patient speaks one of the languages in which services are offered (i.e. German, English, French, Arabic, Kurdish, Dari, Farsi, Urdu, Pashto, Tirginya, Somali)
Who cannot join
- Mental disorder that requires inpatient treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Konstanz, Psychotherapy Outpatient Clinic
Konstanz, 78464
Michael Odenwald, PhD, +49 7531 884621, michael.odenwald@uni-konstanz.de
Anne Schawohl, MA, +49 7531 883589, anne.schawohl@uni-konstanz.de
About this study
Official title: Integration of Refugees With Mental Disorders Into the Public Psychotherapeutic Health Care Services - a Model Project With Trained Peers
There are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the German public health care system. This study aims to evaluate additional organisational components that are hypothesised to improve service utilisation.
In a randomised controlled trial, refugees with mental health problems are identified by peers, subsequently assessed by professional staff and referred to public psychotherapeutic health services who offer standard care. Participants are assigned to care as usual or to "coordinated and peer supported mental health care"; the latter includes several additional organisational assistance components, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and a interpreter pool. Measures include service utilisation and symptom change after 6 months. Furthermore the study evaluates whether trained peers can correctly identify participants with mental health problems.
- Being tested
- "coordinated and peer supported mental health care", "standard psychotherapeutic care in the public healthcare system"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"coordinated and peer supported mental health care"Other
Health services, coordination of services, method to support utilization
"standard psychotherapeutic care in the public healthcare system"Behavioural
Psychotherapeutic services that are financed by the public health insurance system.
| Study group | Role | What they receive |
|---|---|---|
| Standard psychotherapeutic care + coordinated and peer supported mental health care" | Experimental | Participants receive standard psychotherapeutic care in the public healthcare system. For participants and therapists in this group standard care and additional organisational support is available which is labeled "coordinated and peer supported mental health care". This includes several additional organisational assistance components that are currently not part of the services of the public mental health care system, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and an interpreter pool.This is Treatment as Usual plus coordination and peer support. Receives: Other: "coordinated and peer supported mental health care"; Behavioral: "standard psychotherapeutic care in the public healthcare system" |
| Standard psychotherapeutic care" | Other | Participants receive standard psychotherapeutic care in the public healthcare system. For participants in this group no additional organisational support is available. This is Treatment as Usual. Receives: Behavioral: "standard psychotherapeutic care in the public healthcare system" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service utilisation
Percentage of participants who utilise psychotherapeutic services
Measured: 6 months after study inclusion
Psychiatric symptom change
Self-report of psychiatric symptoms by means of questionnaires
Measured: assessments 6 and 12 months after study inclusion
Secondary outcomes (1)
Percentage correctly identified refugees with mental health problems
Comparison of peer screening and expert diagnostic assessment
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric Disorders From Chapters 3 and 4 of ICD10Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Vivo international e.V.
- Responsible party
- Principal investigator, Michael Odenwald, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832035
- Sponsor's protocol ID
- Refugee Integration 2021
- Acronym
- INT_REF_MH
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Refugees With Mental Disorders Into the Public Psychotherapeutic Health Care Services - a Model Project With Trained Peers
- ClinicalTrials.gov ID
- NCT04832035
- Acronym / sponsor ID
- INT_REF_MH / Refugee Integration 2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Vivo international e.V.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 5 Apr 2021 (actual)
- 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.
There are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the German public health care system. This study aims to evaluate additional organisational components that are hypothesised to improve service utilisation.
In a randomised controlled trial, refugees with mental health problems are identified by peers, subsequently assessed by professional staff and referred to public psychotherapeutic health services who offer standard care. Participants are assigned to care as usual or to "coordinated and peer supported mental health care"; the latter includes several additional organisational assistance components, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and a interpreter pool. Measures include service utilisation and symptom change after 6 months. Furthermore the study evaluates whether trained peers can correctly identify participants with mental health problems.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard psychotherapeutic care + coordinated and peer supported mental health care" | Experimental | Other: "coordinated and peer supported mental health care", Behavioral: "standard psychotherapeutic care in the public healthcare system"Participants receive standard psychotherapeutic care in the public healthcare system. For participants and therapists in this group standard care and additional organisational support is available which is labeled "coordinated and peer supported mental health care". This includes several additional organisational assistance components that are currently not part of the services of the public mental health care system, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and an interpreter pool.This is Treatment as Usual plus coordination and peer support. |
| Standard psychotherapeutic care" | Other | Behavioral: "standard psychotherapeutic care in the public healthcare system"Participants receive standard psychotherapeutic care in the public healthcare system. For participants in this group no additional organisational support is available. This is Treatment as Usual. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Psychiatric diagnosis from Chapters 3 and 4 of ICD10
- Participant applied for asylum in Germany
- Entry to Germany after 2012
- Participants is motivated to utilise psychotherapeutic services
- Patient speaks one of the languages in which services are offered (i.e. German, English, French, Arabic, Kurdish, Dari, Farsi, Urdu, Pashto, Tirginya, Somali)
Key exclusion criteria (1 listed)
- Mental disorder that requires inpatient treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "coordinated and peer supported mental health care"Health services, coordination of services, method to support utilization | Other | Standard psychotherapeutic care + coordinated and peer supported mental health care" |
| "standard psychotherapeutic care in the public healthcare system"Psychotherapeutic services that are financed by the public health insurance system. | Behavioural | Standard psychotherapeutic care + coordinated and peer supported mental health care", Standard psychotherapeutic care" |
Primary outcome
Service utilisation
Time frame: 6 months after study inclusion
Percentage of participants who utilise psychotherapeutic services
Psychiatric symptom change
Time frame: assessments 6 and 12 months after study inclusion
Self-report of psychiatric symptoms by means of questionnaires
1 secondary outcome
Percentage correctly identified refugees with mental health problems
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: Undecided
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.
University of Konstanz, Psychotherapy Outpatient Clinic
Konstanz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "coordinated and peer supported mental health care" and "standard psychotherapeutic care in the public healthcare system" in people with Psychiatric Disorders From Chapters 3 and 4 of ICD10, run by University of Konstanz at 1 site 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service utilisation (time frame: 6 months after study inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2021.