PsychosisPEERNCT02276469
Peer Support for Severe Mental Disorders
A study testing peer support in people with Psychosis and Major Depression, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
The purpose of this study is to determine wether peer support is effective for the treatment of people with severe mental illness. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Psychosis, Major Depression, Bipolar Disorder
- What is being tested?
- peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2014
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder
Who cannot join
- primary clinical diagnosis of addiction
About this study
Official title: Randomized Controlled Trial of Peer to Peer Support for People With Severe Mental Disorders: Schizophrenia, Affective Disorders and Personality Disorders in Comparison to Standard Care
The purpose of this study is to determine wether peer support is effective for the treatment of people with severe mental illness.
Read the detailed description
A randomized controlled multi center trial is conducted, where patients receive usual care in the control group and usual care with additional peer support for 6 month in the intervention group. Psychosocial outcome criteria are collected pre intervention, after 6 month intervention and at one year follow up. Days till hospitalization and days spent in hospital are collected for one year before recruitment and one year after recruitment.
- Being tested
- peer support
- Keywords
- severe mental illness
- Medical subject headings
- Psychotic Disorders, Depressive Disorder, Major, Bipolar Disorder, Borderline Personality Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer supportBehavioural
peer support is delivered by persons with a severe mental illness after the experience of recovery and after absolving a one year education to support others on their way to recovery
| Study group | Role | What they receive |
|---|---|---|
| peer support | Experimental | peer support is delivered on individual basis for half a year, the frequency depends on the patients requirement, but at least 3 sessions has to occur Receives: Behavioral: peer support |
| usual care | No intervention | usual care was delivered to the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-Efficacy at 6 month
General Self-Efficacy Scale; Self report Questionnaire; 10 Items
Measured: 1. Baseline; 6 month follow up (post intervention); twelve month follow
Secondary outcomes (9)
Change from Baseline in Quality of life at 6 and 12 month
Self report questionnaires: Modulares System zur Lebensqualität MSLQ-R
Measured: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Quality of life at 6 and 12 month
Self report questionnaires: EuroQol-Group: EQ5D
Measured: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Service satisfaction after six month of intervention
Self report questionnaire: Client Satisfaction Questionnaire CSQ 8
Measured: After six month intervention
Change from Baseline in Illness management, Coping at 6 and 12 month
FKV-LIS Freiburger Self report questionnaire: Fragebogen zur Krankheitsverarbeitung; examining coping strategies
Measured: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Psychosocial functioning at 6 and 12 month
Clinical observation: Global assessment of functioning DSM
Measured: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Severity of illness at 6 and 12 month
Clinical observation: Clinical global impression
Measured: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Illness management, Coping at 6 and 12 month
Self report questionnaire: Subjective sense of psychosis
Measured: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Hospitalization in days of in-patient care
The days of in patient care assessed from the clinical records
Measured: one year before, until one year past intervention
Days to hospitalization
Days to hospitalization after the beginning of treatment assessed from the clinical records
Measured: Baseline until 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. Thomas Bock, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Bock, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276469
- Sponsor's protocol ID
- SC 0748/006
- Other IDs
- Psychenet Teilprojekt 5
- Acronym
- PEER
- Status last verified
- Jan 2015
- First submitted
- 9 Oct 2014
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35- 37). Windsor, England: NFER-NELSON.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801Pukrop, R. (2003). Modulares System zur Lebensqualität. In J. Schumacher, A. Klaiberg & E. Brähler (Hrsg.), Diagnostische Verfahren zu Lebensqualität und Wohlbefinden (S. 227-232). Göttingen Bern Toronto S
National Institute of Mental Health (1976). 028 CGI. Clinical Global Impressions. In: Guy, W. (Ed.), ECDEU Assessment for psychopharmacology. Rev. Ed. Rockville, Maryland. 217-222.
Muthny FA. [References for evaluation scales in quality assurance in rehabilitation--6. Assessment of coping processes with the Freiburg Questionnaire of Illness Coping]. Rehabilitation (Stuttg). 1996 May;35(2):IX-XVI. German.
PubMed 8767546Sass, H., Wittchen, H.U., Zaudig, M. (2001). Diagnostisches und Statistisches Manual psychischer Störungen DSM-IV. Göttingen, Bern, Toronto, Seattle: Hogrefe Verlag für Psychologie
Bock T, Brysinski T, Klapheck K, Bening U, Lenz A, Naber D. [On subjective meaning of psychoses. Construction, validation and first application of a new questionnaire--the SuSi-Project (Hamburg)]. Psychiatr Prax. 2010 Sep;37(6):285-91. doi: 10.1055/s-0030-1248424. Epub 2010 Jun 15. German.
PubMed 20552540
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Peer to Peer Support for People With Severe Mental Disorders: Schizophrenia, Affective Disorders and Personality Disorders in Comparison to Standard Care
- ClinicalTrials.gov ID
- NCT02276469
- Acronym / sponsor ID
- PEER / SC 0748/006
- Keywords
- severe mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Oct 2014 (estimated)
- 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.
The purpose of this study is to determine wether peer support is effective for the treatment of people with severe mental illness.
Detailed description
A randomized controlled multi center trial is conducted, where patients receive usual care in the control group and usual care with additional peer support for 6 month in the intervention group. Psychosocial outcome criteria are collected pre intervention, after 6 month intervention and at one year follow up. Days till hospitalization and days spent in hospital are collected for one year before recruitment and one year after recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peer support | Experimental | Behavioral: peer supportpeer support is delivered on individual basis for half a year, the frequency depends on the patients requirement, but at least 3 sessions has to occur |
| usual care | No intervention | –usual care was delivered to the patients |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder
Key exclusion criteria (1 listed)
- primary clinical diagnosis of addiction
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 |
|---|---|---|
| peer supportpeer support is delivered by persons with a severe mental illness after the experience of recovery and after absolving a one year education to support others on their way to recovery | Behavioural | peer support |
Primary outcome
Change from Baseline in Self-Efficacy at 6 month
Time frame: 1. Baseline; 6 month follow up (post intervention); twelve month follow
General Self-Efficacy Scale; Self report Questionnaire; 10 Items
9 secondary outcomes
Change from Baseline in Quality of life at 6 and 12 month
Time frame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Quality of life at 6 and 12 month
Time frame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Service satisfaction after six month of intervention
Time frame: After six month intervention
Change from Baseline in Illness management, Coping at 6 and 12 month
Time frame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Psychosocial functioning at 6 and 12 month
Time frame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Severity of illness at 6 and 12 month
Time frame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Change from Baseline in Illness management, Coping at 6 and 12 month
Time frame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Hospitalization in days of in-patient care
Time frame: one year before, until one year past intervention
Days to hospitalization
Time frame: Baseline until 12 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- BackgroundSchwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35- 37). Windsor, England: NFER-NELSON.
- Background: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
- BackgroundPukrop, R. (2003). Modulares System zur Lebensqualität. In J. Schumacher, A. Klaiberg & E. Brähler (Hrsg.), Diagnostische Verfahren zu Lebensqualität und Wohlbefinden (S. 227-232). Göttingen Bern Toronto S
- BackgroundNational Institute of Mental Health (1976). 028 CGI. Clinical Global Impressions. In: Guy, W. (Ed.), ECDEU Assessment for psychopharmacology. Rev. Ed. Rockville, Maryland. 217-222.
- Background: PubMed 8767546Muthny FA. [References for evaluation scales in quality assurance in rehabilitation--6. Assessment of coping processes with the Freiburg Questionnaire of Illness Coping]. Rehabilitation (Stuttg). 1996 May;35(2):IX-XVI. German.
- BackgroundSass, H., Wittchen, H.U., Zaudig, M. (2001). Diagnostisches und Statistisches Manual psychischer Störungen DSM-IV. Göttingen, Bern, Toronto, Seattle: Hogrefe Verlag für Psychologie
- Background: PubMed 20552540Bock T, Brysinski T, Klapheck K, Bening U, Lenz A, Naber D. [On subjective meaning of psychoses. Construction, validation and first application of a new questionnaire--the SuSi-Project (Hamburg)]. Psychiatr Prax. 2010 Sep;37(6):285-91. doi: 10.1055/s-0030-1248424. Epub 2010 Jun 15. German.
Related trials for Psychosis
Not yet recruitingPhase 1
Phase I Trial of HHK101 in Patients With Schizophrenia
Schizophrenia
Not yet recruiting
Integrated Psychoeducation Program for Internalized Stigma in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Recruiting
On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
Sleep, Physical Activity
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
RecruitingPhase 3
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Alzheimer Disease
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.
Thomas Bock, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Questions about this trial
What is this clinical trial studying?
A study testing peer support in people with Psychosis and Major Depression, run by Universitätsklinikum Hamburg-Eppendorf.
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 1 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: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Self-Efficacy at 6 month (time frame: 1. Baseline; 6 month follow up (post intervention); twelve month follow). 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 NCT02276469, which also lists 7 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 5 Jan 2015.