Back to resultsPeer Support for Severe Mental Disorders (PEER)
Primary Purpose
Psychosis, Major Depression, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peer support
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring severe mental illness
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder
Exclusion Criteria:
- primary clinical diagnosis of addiction
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
peer support
usual care
Arm Description
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
usual care was delivered to the patients
Outcomes
Primary Outcome Measures
Change from Baseline in Self-Efficacy at 6 month
General Self-Efficacy Scale; Self report Questionnaire; 10 Items
Secondary Outcome Measures
Change from Baseline in Quality of life at 6 and 12 month
Self report questionnaires: Modulares System zur Lebensqualität MSLQ-R
Change from Baseline in Quality of life at 6 and 12 month
Self report questionnaires: EuroQol-Group: EQ5D
Service satisfaction after six month of intervention
Self report questionnaire: Client Satisfaction Questionnaire CSQ 8
Change from Baseline in Illness management, Coping at 6 and 12 month
FKV-LIS Freiburger Self report questionnaire: Fragebogen zur Krankheitsverarbeitung; examining coping strategies
Change from Baseline in Psychosocial functioning at 6 and 12 month
Clinical observation: Global assessment of functioning DSM
Change from Baseline in Severity of illness at 6 and 12 month
Clinical observation: Clinical global impression
Change from Baseline in Illness management, Coping at 6 and 12 month
Self report questionnaire: Subjective sense of psychosis
Hospitalization in days of in-patient care
The days of in patient care assessed from the clinical records
Days to hospitalization
Days to hospitalization after the beginning of treatment assessed from the clinical records
Full Information
NCT ID
NCT02276469
First Posted
October 9, 2014
Last Updated
January 1, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02276469
Brief Title
Peer Support for Severe Mental Disorders
Acronym
PEER
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Major Depression, Bipolar Disorder, Borderline Personality Disorder
Keywords
severe mental illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
peer support
Arm Type
Experimental
Arm Description
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
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care was delivered to the patients
Intervention Type
Behavioral
Intervention Name(s)
peer support
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline in Self-Efficacy at 6 month
Description
General Self-Efficacy Scale; Self report Questionnaire; 10 Items
Time Frame
1. Baseline; 6 month follow up (post intervention); twelve month follow
Secondary Outcome Measure Information:
Title
Change from Baseline in Quality of life at 6 and 12 month
Description
Self report questionnaires: Modulares System zur Lebensqualität MSLQ-R
Time Frame
1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Title
Change from Baseline in Quality of life at 6 and 12 month
Description
Self report questionnaires: EuroQol-Group: EQ5D
Time Frame
1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Title
Service satisfaction after six month of intervention
Description
Self report questionnaire: Client Satisfaction Questionnaire CSQ 8
Time Frame
After six month intervention
Title
Change from Baseline in Illness management, Coping at 6 and 12 month
Description
FKV-LIS Freiburger Self report questionnaire: Fragebogen zur Krankheitsverarbeitung; examining coping strategies
Time Frame
1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Title
Change from Baseline in Psychosocial functioning at 6 and 12 month
Description
Clinical observation: Global assessment of functioning DSM
Time Frame
1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Title
Change from Baseline in Severity of illness at 6 and 12 month
Description
Clinical observation: Clinical global impression
Time Frame
1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Title
Change from Baseline in Illness management, Coping at 6 and 12 month
Description
Self report questionnaire: Subjective sense of psychosis
Time Frame
1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
Title
Hospitalization in days of in-patient care
Description
The days of in patient care assessed from the clinical records
Time Frame
one year before, until one year past intervention
Title
Days to hospitalization
Description
Days to hospitalization after the beginning of treatment assessed from the clinical records
Time Frame
Baseline until 12 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder
Exclusion Criteria:
primary clinical diagnosis of addiction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bock, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf (UKE)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
10109801
Citation
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.
Results Reference
background
Citation
Pukrop, 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
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
8767546
Citation
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.
Results Reference
background
Citation
Sass, H., Wittchen, H.U., Zaudig, M. (2001). Diagnostisches und Statistisches Manual psychischer Störungen DSM-IV. Göttingen, Bern, Toronto, Seattle: Hogrefe Verlag für Psychologie
Results Reference
background
PubMed Identifier
20552540
Citation
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.
Results Reference
background
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Peer Support for Severe Mental Disorders
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