Peer Support for Severe Mental Disorders (PEER)

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Major Depression; Borderline Personality Disorder; Psychosis
• Intervention / Treatment: Behavioral: peer support

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• primary clinical diagnosis of addiction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Service satisfaction after six month of intervention	Self report questionnaire: Client Satisfaction Questionnaire CSQ 8	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	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	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	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	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	one year before, until one year past intervention
Days to hospitalization	Days to hospitalization after the beginning of treatment assessed from the clinical records	Baseline until 12 month follow up

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Thomas Bock, Prof. Dr., University Medical Center Hamburg-Eppendorf (UKE)

Publications and helpful links

General Publications

• 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.
• 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
• Bock et al. (2010) SuSi - Fragebogen zum Subjektiven Sinn von Psychosen

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Estimate): January 5, 2015
• Last Update Submitted That Met QC Criteria: January 1, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: severe mental illness
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Personality Disorders; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Borderline Personality Disorder
• Other Study ID Numbers: SC 0748/006; Psychenet Teilprojekt 5 (Other Identifier: University medicalcenter hamburg-eppendorf)