Peer Support for Severe Mental Disorders

Bipolar Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276469
• Other study ID #: SC 0748/006
• Secondary ID: Psychenet Teilpr
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: January 1, 2015
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• primary clinical diagnosis of addiction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Borderline Personality Disorder
• Depressive Disorder, Major
• Disease
• Major Depression
• Mental Disorders
• Personality Disorders
• Psychosis
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Federal Ministry of Education and Research

References & Publications (7)

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. — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Muthny, F.A. (1989). Freiburger Fragebogen zur Krankheitsverarbeitung (FKV). Manual. Weinheim: Beltz Test GmbH.

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.

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

Sass, H., Wittchen, H.U., Zaudig, M. (2001). Diagnostisches und Statistisches Manual psychischer Störungen DSM-IV. Göttingen, Bern, Toronto, Seattle: Hogrefe Verlag für Psychologie

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Self-Efficacy at 6 month	General Self-Efficacy Scale; Self report Questionnaire; 10 Items	1. Baseline; 6 month follow up (post intervention); twelve month follow	No
Secondary	Change from Baseline in Quality of life at 6 and 12 month	Self report questionnaires: Modulares System zur Lebensqualität MSLQ-R	1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow	No
Secondary	Change from Baseline in Quality of life at 6 and 12 month	Self report questionnaires: EuroQol-Group: EQ5D	1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow	No
Secondary	Service satisfaction after six month of intervention	Self report questionnaire: Client Satisfaction Questionnaire CSQ 8	After six month intervention	No
Secondary	Change from Baseline in Illness management, Coping at 6 and 12 month	FKV-LIS Freiburger Self report questionnaire: Fragebogen zur Krankheitsverarbeitung; examining coping strategies	1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow	No
Secondary	Change from Baseline in Psychosocial functioning at 6 and 12 month	Clinical observation: Global assessment of functioning DSM	1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow	No
Secondary	Change from Baseline in Severity of illness at 6 and 12 month	Clinical observation: Clinical global impression	1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow	No
Secondary	Change from Baseline in Illness management, Coping at 6 and 12 month	Self report questionnaire: Subjective sense of psychosis	1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow	No
Secondary	Hospitalization in days of in-patient care	The days of in patient care assessed from the clinical records	one year before, until one year past intervention	No
Secondary	Days to hospitalization	Days to hospitalization after the beginning of treatment assessed from the clinical records	Baseline until 12 month follow up	No