HoPe: Home Treatment and Peer Support for Acute Mental Health Crisis

NCT ID: NCT04336527

Last Updated: 2023-05-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2023-09-30

Brief Summary

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Home treatment (HT) is an effective treatment modality for patients with severe mental illness (SMI) in acute crisis that can often be considered equivalent to inpatient treatment in terms of treatment outcome. In Peer Support (PS) patients are supported by people with personal experiences in psychiatric crises. The current study investigates a combination of both approaches - a HT plus PS intervention - versus sole HT at different study sites throughout Germany. It is hypothesized that a peer-supported home-delivered treatment (HT plus PS) is more effective than a professional-led home-delivered treatment (HT alone) with respect to the time until hospital readmission, self-efficacy, psychosocial health, recovery orientation, internalized stigma and service satisfaction. Furthermore, it is hypothesized, that a peer-supported home delivered treatment (HT plus PS) is as effective as a professional-led home-delivered treatment (HT alone) with respect to disease severity and general functioning (secondary outcomes).

Detailed Description

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Conditions

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Severe Mental Health Condition With Indication of Hospital Admission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentric, randomised-controlled trial (block randomisation stratified by study site)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigators per study site as well as outcome assessor have no insight on group allocation

Study Groups

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Home Treatment with Peer Support

Patients receive a peer supported home treatment, i.e. treatment by a home treatment/crisis resolution team with a peer support worker.

Group Type EXPERIMENTAL

Home Treatment with Peer Support

Intervention Type BEHAVIORAL

After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support.

Home Treatment without Peer Support

Patients receive conventional home treatment by a home treatment/crisis resolution team without contacts to a peer support worker.

Group Type ACTIVE_COMPARATOR

Home Treatment without Peer Support

Intervention Type BEHAVIORAL

After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual).

Interventions

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Home Treatment with Peer Support

After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support.

Intervention Type BEHAVIORAL

Home Treatment without Peer Support

After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* severe mental illness with indication of hospital admission (F2, F3, F6, F41, F42)

Exclusion Criteria

* primary diagnosis of F0 or F1 (Mental disorders due to known physiological conditions; Mental and behavioral disorders due to psychoactive substance use)
* acute suicidality
* verbal or cognitive impairment severe enough to be unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Candelaria Mahlke, Dr. phil

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum am Urban

Berlin, , Germany

Site Status

Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum Neukölln

Berlin, , Germany

Site Status

Zentrum für Psychosoziale Medizin, Gesundheit Nord, Klinikverbund Bremen

Bremen, , Germany

Site Status

Bezirkskrankenhaus Donauwörth, Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik an der Donau-Ries Klinik

Donauwörth, , Germany

Site Status

Klinik für Psychiatrie und Psychotherapie II, Günzburg, Universitätsklinikum Ulm

Günzburg, , Germany

Site Status

Abteilung für Psychiatrie und Psychotherapie, Asklepios Westklinikum Hamburg

Hamburg, , Germany

Site Status

Psychiatrische Klinik Lüneburg

Lüneburg, , Germany

Site Status

Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Medizinische Hochschule Brandenburg, Immanuel Klinik Rüdersdorf

Rüdersdorf, , Germany

Site Status

Countries

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Germany

References

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Jones SH, Thornicroft G, Coffey M, Dunn G. A brief mental health outcome scale-reliability and validity of the Global Assessment of Functioning (GAF). Br J Psychiatry. 1995 May;166(5):654-9. doi: 10.1192/bjp.166.5.654.

Reference Type BACKGROUND
PMID: 7620753 (View on PubMed)

Forkmann T, Scherer A, Boecker M, Pawelzik M, Jostes R, Gauggel S. The Clinical Global Impression Scale and the influence of patient or staff perspective on outcome. BMC Psychiatry. 2011 May 14;11:83. doi: 10.1186/1471-244X-11-83.

Reference Type BACKGROUND
PMID: 21569566 (View on PubMed)

Schwarzer, R. & Jerusalem, M. (Hrsg.) (1999). Skalen zur Erfassung von Lehrer- und Schülermerkmalen. Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin: Freie Universität Berlin.

Reference Type BACKGROUND

Corrigan PW, Michaels PJ, Vega E, Gause M, Watson AC, Rusch N. Self-stigma of mental illness scale--short form: reliability and validity. Psychiatry Res. 2012 Aug 30;199(1):65-9. doi: 10.1016/j.psychres.2012.04.009. Epub 2012 May 10.

Reference Type BACKGROUND
PMID: 22578819 (View on PubMed)

Sibitz I, Friedrich ME, Unger A, Bachmann A, Benesch T, Amering M. [Internalized Stigma of Schizophrenia: Validation of the German Version of the Internalized Stigma of Mental Illness-Scale (ISMI)]. Psychiatr Prax. 2013 Mar;40(2):83-91. doi: 10.1055/s-0032-1332878. Epub 2013 Jan 25. German.

Reference Type BACKGROUND
PMID: 23354628 (View on PubMed)

Rabung S, Harfst T, Kawski S, Koch U, Wittchen HU, Schulz H. [Psychometric analysis of a short form of the "Hamburg Modules for the Assessment of Psychosocial Health" (HEALTH-49)]. Z Psychosom Med Psychother. 2009;55(2):162-79. doi: 10.13109/zptm.2009.55.2.162. German.

Reference Type BACKGROUND
PMID: 19402020 (View on PubMed)

Williams J, Leamy M, Bird V, Le Boutillier C, Norton S, Pesola F, Slade M. Development and evaluation of the INSPIRE measure of staff support for personal recovery. Soc Psychiatry Psychiatr Epidemiol. 2015 May;50(5):777-86. doi: 10.1007/s00127-014-0983-0. Epub 2014 Nov 20.

Reference Type BACKGROUND
PMID: 25409867 (View on PubMed)

Schmidt J, Lamprecht F, Wittmann WW. [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55. German.

Reference Type BACKGROUND
PMID: 2762479 (View on PubMed)

Gühne, U., Weinmann S., Riedel-Heller S.G., Becker T. (2019). DGPPN S3-Leitlinie Psychosoziale Therapien bei schweren psychischen Erkrankungen. Berlin, Heidelberg: Springer.

Reference Type BACKGROUND

Reinke B, Mahlke C, Botros C, Klaring A, Lambert M, Karow A, Gallinat J, Zapf A, Ozga AK, Holler A, Bustami N, Reimer J, Ludtke J, Schaper O, Lison M, Bechdolf A, Baumgardt J, Spiegel J, Hardt O, Rout S, Memarzadeh S, von Peter S, Schwarz J, Langer C, Glotz S, Frasch K, Rusch N, Kunstler U, Bock T, Becker T. Study protocol of a randomized controlled trial evaluating home treatment with peer support for acute mental health crises (HoPe). BMC Psychiatry. 2022 Sep 19;22(1):619. doi: 10.1186/s12888-022-04247-w.

Reference Type DERIVED
PMID: 36123649 (View on PubMed)

Other Identifiers

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LPEK-0096

Identifier Type: -

Identifier Source: org_study_id

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