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Peer Support for Severe Mental Disorders (PEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276469
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : January 5, 2015
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Prof. Dr. Thomas Bock, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
The purpose of this study is to determine wether peer support is effective for the treatment of people with severe mental illness.

Condition or disease Intervention/treatment Phase
Psychosis Major Depression Bipolar Disorder Borderline Personality Disorder Behavioral: peer support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: peer support
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
Behavioral: peer support
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

No Intervention: usual care
usual care was delivered to the patients



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Self report questionnaires: Modulares System zur Lebensqualität MSLQ-R

  2. 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 ]
    Self report questionnaires: EuroQol-Group: EQ5D

  3. Service satisfaction after six month of intervention [ Time Frame: After six month intervention ]
    Self report questionnaire: Client Satisfaction Questionnaire CSQ 8

  4. 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 ]
    FKV-LIS Freiburger Self report questionnaire: Fragebogen zur Krankheitsverarbeitung; examining coping strategies

  5. 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 ]
    Clinical observation: Global assessment of functioning DSM

  6. 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 ]
    Clinical observation: Clinical global impression

  7. 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 ]
    Self report questionnaire: Subjective sense of psychosis

  8. Hospitalization in days of in-patient care [ Time Frame: one year before, until one year past intervention ]
    The days of in patient care assessed from the clinical records

  9. Days to hospitalization [ Time Frame: Baseline until 12 month follow up ]
    Days to hospitalization after the beginning of treatment assessed from the clinical records



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder

Exclusion Criteria:

  • primary clinical diagnosis of addiction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276469


Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Thomas Bock, Prof. Dr. University Medical Center Hamburg-Eppendorf (UKE)
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.
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
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, F.A. (1989). Freiburger Fragebogen zur Krankheitsverarbeitung (FKV). Manual. Weinheim: Beltz Test GmbH.
Sass, H., Wittchen, H.U., Zaudig, M. (2001). Diagnostisches und Statistisches Manual psychischer Störungen DSM-IV. Göttingen, Bern, Toronto, Seattle: Hogrefe Verlag für Psychologie

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Responsible Party: Prof. Dr. Thomas Bock, Prof.Dr., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02276469    
Other Study ID Numbers: SC 0748/006
Psychenet Teilprojekt 5 ( Other Identifier: University medicalcenter hamburg-eppendorf )
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015
Keywords provided by Prof. Dr. Thomas Bock, Universitätsklinikum Hamburg-Eppendorf:
severe mental illness
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders