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| Name | Class |
|---|---|
| University of Ulm | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Treatment with Peer Support | Experimental | Patients 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 Support | Active Comparator | Patients receive conventional home treatment by a home treatment/crisis resolution team without contacts to a peer support worker. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Treatment with Peer Support | Behavioral | After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first readmission to inpatient hospital treatment | 1 year after last patient in |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Candelaria Mahlke, Dr. phil | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum am Urban | Berlin | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7620753 | Background | Jones SH, Thornicroft G, Coffey M, Dunn G. A brief mental health outcome scale-reliability and validity of the Global Assessment of Functioning (GAF). Br J Psychiatry. 1995 May;166(5):654-9. doi: 10.1192/bjp.166.5.654. | |
| 21569566 | Background | Forkmann T, Scherer A, Boecker M, Pawelzik M, Jostes R, Gauggel S. The Clinical Global Impression Scale and the influence of patient or staff perspective on outcome. BMC Psychiatry. 2011 May 14;11:83. doi: 10.1186/1471-244X-11-83. |
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Multicentric, randomised-controlled trial (block randomisation stratified by study site)
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Investigators per study site as well as outcome assessor have no insight on group allocation
| Home Treatment without Peer Support | Behavioral | After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual). |
|
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 |
| 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 | Germany |
| Background | Schwarzer, R. & Jerusalem, M. (Hrsg.) (1999). Skalen zur Erfassung von Lehrer- und Schülermerkmalen. Dokumentation der psychometrischen Verfahren im Rahmen der Wissenschaftlichen Begleitung des Modellversuchs Selbstwirksame Schulen. Berlin: Freie Universität Berlin. |
| 22578819 | Background | Corrigan PW, Michaels PJ, Vega E, Gause M, Watson AC, Rusch N. Self-stigma of mental illness scale--short form: reliability and validity. Psychiatry Res. 2012 Aug 30;199(1):65-9. doi: 10.1016/j.psychres.2012.04.009. Epub 2012 May 10. |
| 23354628 | Background | Sibitz I, Friedrich ME, Unger A, Bachmann A, Benesch T, Amering M. [Internalized Stigma of Schizophrenia: Validation of the German Version of the Internalized Stigma of Mental Illness-Scale (ISMI)]. Psychiatr Prax. 2013 Mar;40(2):83-91. doi: 10.1055/s-0032-1332878. Epub 2013 Jan 25. German. |
| 19402020 | Background | Rabung S, Harfst T, Kawski S, Koch U, Wittchen HU, Schulz H. [Psychometric analysis of a short form of the "Hamburg Modules for the Assessment of Psychosocial Health" (HEALTH-49)]. Z Psychosom Med Psychother. 2009;55(2):162-79. doi: 10.13109/zptm.2009.55.2.162. German. |
| 25409867 | Background | Williams J, Leamy M, Bird V, Le Boutillier C, Norton S, Pesola F, Slade M. Development and evaluation of the INSPIRE measure of staff support for personal recovery. Soc Psychiatry Psychiatr Epidemiol. 2015 May;50(5):777-86. doi: 10.1007/s00127-014-0983-0. Epub 2014 Nov 20. |
| 2762479 | Background | Schmidt J, Lamprecht F, Wittmann WW. [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55. German. |
| 27485931 | Background | Guhne U, Becker T, Riedel-Heller S. [Psychosocial Therapies in Severe Mental Illness: Outlook on the Update of the DGPPN-S3-Guideline]. Psychother Psychosom Med Psychol. 2016 Aug;66(8):337-40. doi: 10.1055/s-0042-111733. Epub 2016 Aug 2. German. |
| 36123649 | Derived | Reinke B, Mahlke C, Botros C, Klaring A, Lambert M, Karow A, Gallinat J, Zapf A, Ozga AK, Holler A, Bustami N, Reimer J, Ludtke J, Schaper O, Lison M, Bechdolf A, Baumgardt J, Spiegel J, Hardt O, Rout S, Memarzadeh S, von Peter S, Schwarz J, Langer C, Glotz S, Frasch K, Rusch N, Kunstler U, Bock T, Becker T. Study protocol of a randomized controlled trial evaluating home treatment with peer support for acute mental health crises (HoPe). BMC Psychiatry. 2022 Sep 19;22(1):619. doi: 10.1186/s12888-022-04247-w. |