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

Study Overview
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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).

Official Title
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HoPe: Home Delivered Peer Led Treatment vs Home Delivered Treatment - a Randomized Controlled Multicentre Trial

Conditions
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Severe Mental Health Condition With Indication of Hospital Admission

Intervention / Treatment
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* Behavioral: Home Treatment with Peer Support
* Behavioral: Home Treatment without Peer Support


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentric, randomised-controlled trial (block randomisation stratified by study site)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Treatment with Peer Support<br>Patients receive a peer supported home treatment, i.e. treatment by a home treatment/crisis resolution team with a peer support worker. | Behavioral: Home Treatment with Peer Support<br>* After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support.<br>|
| Active Comparator: Home Treatment without Peer Support<br>Patients receive conventional home treatment by a home treatment/crisis resolution team without contacts to a peer support worker. | Behavioral: Home Treatment without Peer Support<br>* After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first readmission to inpatient hospital treatment |  | 1 year after last patient in | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |