Severe Mental Health Condition With Indication of Hospital Admission Clinical Trial
— HoPeOfficial title:
HoPe: Home Delivered Peer Led Treatment vs Home Delivered Treatment - a Randomized Controlled Multicentre Trial
| Verified date | May 2023 |
| Source | Universitätsklinikum Hamburg-Eppendorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Active, not recruiting |
| Enrollment | 201 |
| Est. completion date | September 2023 |
| Est. primary completion date | August 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum am Urban | Berlin | |
| Germany | Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum Neukölln | Berlin | |
| Germany | Zentrum für Psychosoziale Medizin, Gesundheit Nord, Klinikverbund Bremen | Bremen | |
| Germany | Bezirkskrankenhaus Donauwörth, Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik an der Donau-Ries Klinik | Donauwörth | |
| Germany | Klinik für Psychiatrie und Psychotherapie II, Günzburg, Universitätsklinikum Ulm | Günzburg | |
| Germany | Abteilung für Psychiatrie und Psychotherapie, Asklepios Westklinikum Hamburg | Hamburg | |
| Germany | Psychiatrische Klinik Lüneburg | Lüneburg | |
| Germany | Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Medizinische Hochschule Brandenburg, Immanuel Klinik Rüdersdorf | Rüdersdorf |
| Lead Sponsor | Collaborator |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | University of Ulm |
Germany,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first readmission to inpatient hospital treatment | 1 year after last patient in | ||
| Secondary | change from baseline in self-efficacy expectation scores as assessed by SWE at two months | SWE = Skala zur Allgemeinen Selbstwirksamkeitserwartung by Schwarzer & Jerusalem (1999); minimum value = 10; maximum value = 40; higher scores mean a better outcome | two months after allocation | |
| Secondary | change from baseline in self-efficacy expectation scores as assessed by SWE at six months | SWE = Skala zur Allgemeinen Selbstwirksamkeitserwartung by Schwarzer & Jerusalem (1999); minimum value = 10; maximum value = 40; higher scores mean a better outcome | six months after allocation | |
| Secondary | change from baseline in self-efficacy expectation scores as assessed by SWE at twelve months | SWE = Skala zur Allgemeinen Selbstwirksamkeitserwartung by Schwarzer & Jerusalem (1999); minimum value = 10; maximum value = 40; higher scores mean a better outcome | twelve months after allocation | |
| Secondary | change from baseline in psychosocial health scores as assessed by Health-49 at two months | 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) | two months after allocation | |
| Secondary | change from baseline in psychosocial health scores as assessed by Health-49 at six months | 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) | six months after allocation | |
| Secondary | change from baseline in psychosocial health scores as assessed by Health-49 at twelve months | 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) | twelve months after allocation | |
| Secondary | means in recovery support scores as assessed by Brief INSPIRE at two months | 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 | two months after allocation | |
| Secondary | means in recovery support scores as assessed by Brief INSPIRE at six months | 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 | six months after allocation | |
| Secondary | means in recovery support scores as assessed by Brief INSPIRE at twelve months | 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 | twelve months after allocation | |
| Secondary | change from baseline in stigma resistance scores as assessed by ISMI at two months | 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 | two months after allocation | |
| Secondary | change from baseline in stigma resistance scores as assessed by ISMI at six months | 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 | six months after allocation | |
| Secondary | change from baseline in stigma resistance scores as assessed by ISMI at twelve months | 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 | twelve months after allocation | |
| Secondary | means in service satisfaction scores as assessed by ZUF-8 at two months | ZUF-8 = Fragebogen zur Messung der Patientenzufriedenheit by Schmidt et al. (1989); minimum value = 8; maximum value = 32; higher scores mean a better outcome | two months after allocation | |
| Secondary | means in service satisfaction scores as assessed by ZUF-8 at six months | ZUF-8 = Fragebogen zur Messung der Patientenzufriedenheit by Schmidt et al. (1989); minimum value = 8; maximum value = 32; higher scores mean a better outcome | six months after allocation | |
| Secondary | means in service satisfaction scores as assessed by ZUF-8 at twelve months | ZUF-8 = Fragebogen zur Messung der Patientenzufriedenheit by Schmidt et al. (1989); minimum value = 8; maximum value = 32; higher scores mean a better outcome | twelve months after allocation | |
| Secondary | change from baseline in disease severity scores ay assessed by CGI at two months | CGI = clinical global impressions, see Forkmann et al., 2011; minimun value = 1; maximum value = 7; higher scores mean a worse outcome | two months after allocation | |
| Secondary | change from baseline in disease severity scores ay assessed by CGI at six months | CGI = clinical global impressions, see Forkmann et al., 2011; minimun value = 1; maximum value = 7; higher scores mean a worse outcome | six months after allocation | |
| Secondary | change from baseline in disease severity scores ay assessed by CGI at twelve months | CGI = clinical global impressions, see Forkmann et al., 2011; minimun value = 1; maximum value = 7; higher scores mean a worse outcome | twelve months after allocation | |
| Secondary | change from baseline in general functioning scores as assessed by GAF at two months | GAF = Global Assessment of Functioning by Jones et al. (1995), minimum value = 0; maximum value = 100; higher scores mean a better outcome | two months after allocation | |
| Secondary | change from baseline in general functioning scores as assessed by GAF at six months | GAF = Global Assessment of Functioning by Jones et al. (1995), minimum value = 0; maximum value = 100; higher scores mean a better outcome | six months after allocation | |
| Secondary | change from baseline in general functioning scores as assessed by GAF at twelve months | GAF = Global Assessment of Functioning by Jones et al. (1995), minimum value = 0; maximum value = 100; higher scores mean a better outcome | twelve months after allocation |