Severe Mental Health Condition With Indication of Hospital AdmissionHoPeNCT04336527
HoPe: Home Treatment and Peer Support for Acute Mental Health Crisis
A study testing Home Treatment with Peer Support and Home Treatment without Peer Support in people with Severe Mental Health Condition With Indication of Hospital Admission, run by Universitätsklinikum Hamburg-Eppendorf at 8 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Health Condition With Indication of Hospital Admission
- What is being tested?
- Home Treatment with Peer Support and Home Treatment without Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 8 sitesGermany
- Study dates
- 21 Jul 2020to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe mental illness with indication of hospital admission (F2, F3, F6, F41, F42)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum am Urban
Berlin
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Vivantes Klinikum Neukölln
Berlin
Zentrum für Psychosoziale Medizin, Gesundheit Nord, Klinikverbund Bremen
Bremen
Bezirkskrankenhaus Donauwörth, Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik an der Donau-Ries Klinik
Donauwörth
Klinik für Psychiatrie und Psychotherapie II, Günzburg, Universitätsklinikum Ulm
Günzburg
Abteilung für Psychiatrie und Psychotherapie, Asklepios Westklinikum Hamburg
Hamburg
Psychiatrische Klinik Lüneburg
Lüneburg
Abteilung für Psychiatrie, Psychotherapie und Psychosomatik, Medizinische Hochschule Brandenburg, Immanuel Klinik Rüdersdorf
Rüdersdorf
About this study
Official title: 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).
- Being tested
- Home Treatment with Peer Support, Home Treatment without Peer Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Treatment with Peer SupportBehavioural
After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support.
Home Treatment without Peer SupportBehavioural
After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Home Treatment with Peer Support |
| 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. Receives: Behavioral: Home Treatment without Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first readmission to inpatient hospital treatment
Measured: 1 year after last patient in
Secondary outcomes (21)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: twelve months after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start21 Jul 2020
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Severe Mental Health Condition With Indication of Hospital AdmissionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, randomised-controlled trial (block randomisation stratified by study site)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm
- Responsible party
- Sponsor
- Investigators
- Candelaria Mahlke, Dr. phil, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336527
- Sponsor's protocol ID
- LPEK-0096
- Acronym
- HoPe
- Status last verified
- May 2023
- First submitted
- 30 Mar 2020
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 7620753Forkmann 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.
PubMed 21569566Schwarzer, 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.
PubMed 22578819Sibitz 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.
PubMed 23354628Rabung 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.
PubMed 19402020Williams 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.
PubMed 25409867Schmidt 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.
PubMed 2762479Guhne 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.
PubMed 27485931Reinke 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.
PubMed 36123649
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HoPe: Home Delivered Peer Led Treatment vs Home Delivered Treatment - a Randomized Controlled Multicentre Trial
- ClinicalTrials.gov ID
- NCT04336527
- Acronym / sponsor ID
- HoPe / LPEK-0096
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University of Ulm
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric, randomised-controlled trial (block randomisation stratified by study site)
| Arm | Type | Receives |
|---|---|---|
| Home Treatment with Peer Support | Experimental | Behavioral: Home Treatment with Peer SupportPatients 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 | Behavioral: Home Treatment without Peer SupportPatients receive conventional home treatment by a home treatment/crisis resolution team without contacts to a peer support worker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe mental illness with indication of hospital admission (F2, F3, F6, F41, F42)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Treatment with Peer SupportAfter allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support. | Behavioural | Home Treatment with Peer Support |
| Home Treatment without Peer SupportAfter allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual). | Behavioural | Home Treatment without Peer Support |
Primary outcome
Time to first readmission to inpatient hospital treatment
Time frame: 1 year after last patient in
21 secondary outcomes
change from baseline in self-efficacy expectation scores as assessed by SWE at two months
Time frame: two months after allocation
change from baseline in self-efficacy expectation scores as assessed by SWE at six months
Time frame: six months after allocation
change from baseline in self-efficacy expectation scores as assessed by SWE at twelve months
Time frame: twelve months after allocation
change from baseline in psychosocial health scores as assessed by Health-49 at two months
Time frame: two months after allocation
change from baseline in psychosocial health scores as assessed by Health-49 at six months
Time frame: six months after allocation
change from baseline in psychosocial health scores as assessed by Health-49 at twelve months
Time frame: twelve months after allocation
means in recovery support scores as assessed by Brief INSPIRE at two months
Time frame: two months after allocation
means in recovery support scores as assessed by Brief INSPIRE at six months
Time frame: six months after allocation
means in recovery support scores as assessed by Brief INSPIRE at twelve months
Time frame: twelve months after allocation
change from baseline in stigma resistance scores as assessed by ISMI at two months
Time frame: two months after allocation
change from baseline in stigma resistance scores as assessed by ISMI at six months
Time frame: six months after allocation
change from baseline in stigma resistance scores as assessed by ISMI at twelve months
Time frame: twelve months after allocation
means in service satisfaction scores as assessed by ZUF-8 at two months
Time frame: two months after allocation
means in service satisfaction scores as assessed by ZUF-8 at six months
Time frame: six months after allocation
means in service satisfaction scores as assessed by ZUF-8 at twelve months
Time frame: twelve months after allocation
change from baseline in disease severity scores ay assessed by CGI at two months
Time frame: two months after allocation
change from baseline in disease severity scores ay assessed by CGI at six months
Time frame: six months after allocation
change from baseline in disease severity scores ay assessed by CGI at twelve months
Time frame: twelve months after allocation
change from baseline in general functioning scores as assessed by GAF at two months
Time frame: two months after allocation
change from baseline in general functioning scores as assessed by GAF at six months
Time frame: six months after allocation
change from baseline in general functioning scores as assessed by GAF at twelve months
Time frame: twelve months after allocation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 7620753Jones 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.
- Background: PubMed 21569566Forkmann 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.
- BackgroundSchwarzer, 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.
- Background: PubMed 22578819Corrigan 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.
- Background: PubMed 23354628Sibitz 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.
- Background: PubMed 19402020Rabung 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.
- Background: PubMed 25409867Williams 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.
- Background: PubMed 2762479Schmidt 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.
- Background: PubMed 27485931Guhne 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.
- Derived from this study: PubMed 36123649Reinke 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candelaria Mahlke, Dr. phil principal investigator
Universitätsklinikum Hamburg-Eppendorf
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Treatment with Peer Support and Home Treatment without Peer Support in people with Severe Mental Health Condition With Indication of Hospital Admission, run by Universitätsklinikum Hamburg-Eppendorf at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first readmission to inpatient hospital treatment (time frame: 1 year after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336527, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.