Severe Mental Health Condition With Indication of Hospital Admission
Conditions
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).
Interventions
BEHAVIORALHome Treatment with Peer Support
After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support.
BEHAVIORALHome Treatment without Peer Support
After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual).
Sponsors
University of Ulm
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators per study site as well as outcome assessor have no insight on group allocation
Intervention model description
Multicentric, randomised-controlled trial (block randomisation stratified by study site)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first readmission to inpatient hospital treatment | 1 year after last patient in |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in stigma resistance scores as assessed by ISMI at two months | two 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 months | two 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 six months | six 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 months | twelve 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 two months | two 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 six months | six 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 six months | six 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 twelve months | twelve 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 months | two 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 six months | six 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 months | twelve 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 two months | two 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 |
| means in service satisfaction scores as assessed by ZUF-8 at six months | six 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 |
| means in service satisfaction scores as assessed by ZUF-8 at twelve months | twelve 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 months | two 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 six months | six 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 months | twelve 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 months | two 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 general functioning scores as assessed by GAF at six months | six 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 general functioning scores as assessed by GAF at twelve months | twelve 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 twelve months | twelve 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 |
Countries
Germany
Outcome results
None listed