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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Mental Health Condition With Indication of Hospital Admission
• Intervention / Treatment: Behavioral: Home Treatment with Peer Support; Behavioral: Home Treatment without Peer Support

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum am Urban
  • Berlin, Germany
    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum Neukölln
  • Bremen, Germany
    • Zentrum für Psychosoziale Medizin, Gesundheit Nord, Klinikverbund Bremen
  • Donauwörth, Germany
    • Bezirkskrankenhaus Donauwörth, Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik an der Donau-Ries Klinik
  • Günzburg, Germany
    • Klinik für Psychiatrie und Psychotherapie II, Günzburg, Universitätsklinikum Ulm
  • Hamburg, Germany
    • Abteilung für Psychiatrie und Psychotherapie, Asklepios Westklinikum Hamburg
  • Lüneburg, Germany
    • Psychiatrische Klinik Lüneburg
  • Rüdersdorf, Germany
    • Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Medizinische Hochschule Brandenburg, Immanuel Klinik Rüdersdorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Treatment with Peer Support; 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; After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support.
Active Comparator: Home Treatment without Peer Support; 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; After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
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
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
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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: University of Ulm
• Investigators: Principal Investigator: Candelaria Mahlke, Dr. phil, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Gühne, U., Weinmann S., Riedel-Heller S.G., Becker T. (2019). DGPPN S3-Leitlinie Psychosoziale Therapien bei schweren psychischen Erkrankungen. Berlin, Heidelberg: Springer.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 28, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LPEK-0096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No