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

Not Applicable
Active, not recruiting
Conditions
Severe Mental Health Condition With Indication of Hospital Admission
Interventions
Behavioral: Home Treatment with Peer Support
Behavioral: Home Treatment without Peer Support
Registration Number
NCT04336527
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
201
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Home Treatment with Peer SupportHome Treatment with Peer SupportPatients receive a peer supported home treatment, i.e. treatment by a home treatment/crisis resolution team with a peer support worker.
Home Treatment without Peer SupportHome Treatment without Peer SupportPatients receive conventional home treatment by a home treatment/crisis resolution team without contacts to a peer support worker.
Primary Outcome Measures
NameTimeMethod
Time to first readmission to inpatient hospital treatment1 year after last patient in
Secondary Outcome Measures
NameTimeMethod
means in recovery support scores as assessed by Brief INSPIRE at six monthssix months after allocation

Brief INSPIRE is a short version of INSPIRE by Williams et al. (2015); minimum value = 0; maximum value = 100; higher scores mean a better outcome

means in recovery support scores as assessed by Brief INSPIRE at twelve monthstwelve months after allocation

Brief INSPIRE is a short version of INSPIRE by Williams et al. (2015); minimum value = 0; maximum value = 100; higher scores mean a better outcome

change from baseline in stigma resistance scores as assessed by ISMI at two monthstwo months after allocation

ISMI = Internalized Stigma of Mental Illness Inventory by Sibitz et al. (2013); subscale stigma resistance; minimum value: 5; maximum value = 20; higher scores mean a better outcome

change from baseline in psychosocial health scores as assessed by Health-49 at two monthstwo months after allocation

Health-49 = Hamburger Module zur Erfassung allgemeiner Aspekte psychosozialer Gesundheit für die therapeutische Praxis by Rabung et al. (2009); subscales: somatoform complaints (SOM; min-max values=0-28; higher scores mean aworse outcome); depressiveness (DEP; min-max=0-24, higher values mean a worse outcome); phobic anxiety (PHO; min-max=0-20; higher values mean a worse outcome); psychological and somatoform complaints (PSB; min-max=0-72; higher values mean a worse outcome); psychological wellbeing (WOHL; min-max=0-20; higher values mean a better outcome); interactional problems (INT; min-max=0-28; higher values mean a worse outcome); self-efficacy (SELB; min-max=0-20; higher values mean a better outcome); activity and participation (A\&P; min-max=0-24; higher values mean a better outcome); social support (SOZU; min-max = 0-16; higher values mean a better outcome); social stress (SOZB, min-max=0-16; higher values mean a worse outcome)

change from baseline in psychosocial health scores as assessed by Health-49 at twelve monthstwelve months after allocation

Health-49 = Hamburger Module zur Erfassung allgemeiner Aspekte psychosozialer Gesundheit für die therapeutische Praxis by Rabung et al. (2009); subscales: somatoform complaints (SOM; min-max values=0-28; higher scores mean aworse outcome); depressiveness (DEP; min-max=0-24, higher values mean a worse outcome); phobic anxiety (PHO; min-max=0-20; higher values mean a worse outcome); psychological and somatoform complaints (PSB; min-max=0-72; higher values mean a worse outcome); psychological wellbeing (WOHL; min-max=0-20; higher values mean a better outcome); interactional problems (INT; min-max=0-28; higher values mean a worse outcome); self-efficacy (SELB; min-max=0-20; higher values mean a better outcome); activity and participation (A\&P; min-max=0-24; higher values mean a better outcome); social support (SOZU; min-max = 0-16; higher values mean a better outcome); social stress (SOZB, min-max=0-16; higher values mean a worse outcome)

change from baseline in stigma resistance scores as assessed by ISMI at twelve monthstwelve months after allocation

ISMI = Internalized Stigma of Mental Illness Inventory by Sibitz et al. (2013); subscale stigma resistance; minimum value: 5; maximum value = 20; higher scores mean a better outcome

change from baseline in self-efficacy expectation scores as assessed by SWE at two monthstwo months after allocation

SWE = Skala zur Allgemeinen Selbstwirksamkeitserwartung by Schwarzer \& Jerusalem (1999); minimum value = 10; maximum value = 40; higher scores mean a better outcome

change from baseline in self-efficacy expectation scores as assessed by SWE at twelve monthstwelve months after allocation

SWE = Skala zur Allgemeinen Selbstwirksamkeitserwartung by Schwarzer \& Jerusalem (1999); minimum value = 10; maximum value = 40; higher scores mean a better outcome

means in service satisfaction scores as assessed by ZUF-8 at twelve monthstwelve months after allocation

ZUF-8 = Fragebogen zur Messung der Patientenzufriedenheit by Schmidt et al. (1989); minimum value = 8; maximum value = 32; higher scores mean a better outcome

change from baseline in disease severity scores ay assessed by CGI at two monthstwo months after allocation

CGI = clinical global impressions, see Forkmann et al., 2011; minimun value = 1; maximum value = 7; higher scores mean a worse outcome

change from baseline in general functioning scores as assessed by GAF at two monthstwo months after allocation

GAF = Global Assessment of Functioning by Jones et al. (1995), minimum value = 0; maximum value = 100; higher scores mean a better outcome

change from baseline in self-efficacy expectation scores as assessed by SWE at six monthssix months after allocation

SWE = Skala zur Allgemeinen Selbstwirksamkeitserwartung by Schwarzer \& Jerusalem (1999); minimum value = 10; maximum value = 40; higher scores mean a better outcome

change from baseline in psychosocial health scores as assessed by Health-49 at six monthssix months after allocation

Health-49 = Hamburger Module zur Erfassung allgemeiner Aspekte psychosozialer Gesundheit für die therapeutische Praxis by Rabung et al. (2009); subscales: somatoform complaints (SOM; min-max values=0-28; higher scores mean aworse outcome); depressiveness (DEP; min-max=0-24, higher values mean a worse outcome); phobic anxiety (PHO; min-max=0-20; higher values mean a worse outcome); psychological and somatoform complaints (PSB; min-max=0-72; higher values mean a worse outcome); psychological wellbeing (WOHL; min-max=0-20; higher values mean a better outcome); interactional problems (INT; min-max=0-28; higher values mean a worse outcome); self-efficacy (SELB; min-max=0-20; higher values mean a better outcome); activity and participation (A\&P; min-max=0-24; higher values mean a better outcome); social support (SOZU; min-max = 0-16; higher values mean a better outcome); social stress (SOZB, min-max=0-16; higher values mean a worse outcome)

means in recovery support scores as assessed by Brief INSPIRE at two monthstwo months after allocation

Brief INSPIRE is a short version of INSPIRE by Williams et al. (2015); minimum value = 0; maximum value = 100; higher scores mean a better outcome

means in service satisfaction scores as assessed by ZUF-8 at six monthssix months after allocation

ZUF-8 = Fragebogen zur Messung der Patientenzufriedenheit by Schmidt et al. (1989); minimum value = 8; maximum value = 32; higher scores mean a better outcome

change from baseline in disease severity scores ay assessed by CGI at six monthssix months after allocation

CGI = clinical global impressions, see Forkmann et al., 2011; minimun value = 1; maximum value = 7; higher scores mean a worse outcome

change from baseline in disease severity scores ay assessed by CGI at twelve monthstwelve months after allocation

CGI = clinical global impressions, see Forkmann et al., 2011; minimun value = 1; maximum value = 7; higher scores mean a worse outcome

change from baseline in general functioning scores as assessed by GAF at six monthssix months after allocation

GAF = Global Assessment of Functioning by Jones et al. (1995), minimum value = 0; maximum value = 100; higher scores mean a better outcome

change from baseline in stigma resistance scores as assessed by ISMI at six monthssix months after allocation

ISMI = Internalized Stigma of Mental Illness Inventory by Sibitz et al. (2013); subscale stigma resistance; minimum value: 5; maximum value = 20; higher scores mean a better outcome

means in service satisfaction scores as assessed by ZUF-8 at two monthstwo months after allocation

ZUF-8 = Fragebogen zur Messung der Patientenzufriedenheit by Schmidt et al. (1989); minimum value = 8; maximum value = 32; higher scores mean a better outcome

change from baseline in general functioning scores as assessed by GAF at twelve monthstwelve months after allocation

GAF = Global Assessment of Functioning by Jones et al. (1995), minimum value = 0; maximum value = 100; higher scores mean a better outcome

Trial Locations

Locations (8)

Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum Neukölln

🇩🇪

Berlin, Germany

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

🇩🇪

Berlin, Germany

Abteilung für Psychiatrie und Psychotherapie, Asklepios Westklinikum Hamburg

🇩🇪

Hamburg, Germany

Klinik für Psychiatrie und Psychotherapie II, Günzburg, Universitätsklinikum Ulm

🇩🇪

Günzburg, Germany

Zentrum für Psychosoziale Medizin, Gesundheit Nord, Klinikverbund Bremen

🇩🇪

Bremen, Germany

Psychiatrische Klinik Lüneburg

🇩🇪

Lüneburg, Germany

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

🇩🇪

Donauwörth, Germany

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

🇩🇪

Rüdersdorf, Germany

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