Clinical trial NCT04336527: HoPe: Home Treatment and Peer Support for Acute Mental Health Crisis
Official title: HoPe: Home Delivered Peer Led Treatment vs Home Delivered Treatment - a Randomized Controlled Multicentre Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Mental Health Condition With Indication of Hospital Admission
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University of Ulm
First posted: 2020-04-07
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric, randomised-controlled trial (block randomisation stratified by study site)
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Time to first readmission to inpatient hospital treatment
timeFrame: 1 year after last patient in
Secondary outcomes:
measure: change from baseline in self-efficacy expectation scores as assessed by SWE at two months
timeFrame: two months after allocation
measure: change from baseline in self-efficacy expectation scores as assessed by SWE at six months
timeFrame: six months after allocation
measure: change from baseline in self-efficacy expectation scores as assessed by SWE at twelve months
timeFrame: twelve months after allocation
measure: change from baseline in psychosocial health scores as assessed by Health-49 at two months
timeFrame: two months after allocation
measure: change from baseline in psychosocial health scores as assessed by Health-49 at six months
timeFrame: six months after allocation
measure: change from baseline in psychosocial health scores as assessed by Health-49 at twelve months
timeFrame: twelve months after allocation
measure: means in recovery support scores as assessed by Brief INSPIRE at two months
timeFrame: two months after allocation
measure: means in recovery support scores as assessed by Brief INSPIRE at six months
timeFrame: six months after allocation
measure: means in recovery support scores as assessed by Brief INSPIRE at twelve months
timeFrame: twelve months after allocation
measure: change from baseline in stigma resistance scores as assessed by ISMI at two months
timeFrame: two months after allocation
measure: change from baseline in stigma resistance scores as assessed by ISMI at six months
timeFrame: six months after allocation
measure: change from baseline in stigma resistance scores as assessed by ISMI at twelve months
timeFrame: twelve months after allocation
measure: means in service satisfaction scores as assessed by ZUF-8 at two months
timeFrame: two months after allocation
measure: means in service satisfaction scores as assessed by ZUF-8 at six months
timeFrame: six months after allocation
measure: means in service satisfaction scores as assessed by ZUF-8 at twelve months
timeFrame: twelve months after allocation
measure: change from baseline in disease severity scores ay assessed by CGI at two months
timeFrame: two months after allocation
measure: change from baseline in disease severity scores ay assessed by CGI at six months
timeFrame: six months after allocation
measure: change from baseline in disease severity scores ay assessed by CGI at twelve months
timeFrame: twelve months after allocation
measure: change from baseline in general functioning scores as assessed by GAF at two months
timeFrame: two months after allocation
measure: change from baseline in general functioning scores as assessed by GAF at six months
timeFrame: six months after allocation
measure: change from baseline in general functioning scores as assessed by GAF at twelve months
timeFrame: twelve months after allocation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum Neukölln
city: Bremen
country: Germany
facility: Zentrum für Psychosoziale Medizin, Gesundheit Nord, Klinikverbund Bremen
city: Donauwörth
country: Germany
facility: Bezirkskrankenhaus Donauwörth, Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik an der Donau-Ries Klinik
city: Günzburg
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie II, Günzburg, Universitätsklinikum Ulm
city: Hamburg
country: Germany
facility: Abteilung für Psychiatrie und Psychotherapie, Asklepios Westklinikum Hamburg
city: Lüneburg
country: Germany
facility: Psychiatrische Klinik Lüneburg
city: Rüdersdorf
country: Germany
facility: Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Medizinische Hochschule Brandenburg, Immanuel Klinik Rüdersdorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Candelaria Mahlke, Dr. phil
role: PRINCIPAL_INVESTIGATOR
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