Overview

This trial is active, not recruiting.

Conditions psychosis, major depression, bipolar disorder, borderline personality disorder
Treatment peer support
Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborator German Federal Ministry of Education and Research
Start date July 2011
End date October 2014
Trial size 200 participants
Trial identifier NCT02276469, Psychenet Teilprojekt 5, SC 0748/006

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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
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 was delivered to the patients

Primary Outcomes

Measure
Change from Baseline in Self-Efficacy at 6 month
time frame: 1. Baseline; 6 month follow up (post intervention); twelve month follow

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 17 years old.

Inclusion Criteria: - clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder Exclusion Criteria: - primary clinical diagnosis of addiction

Additional Information

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
Principal investigator Thomas Bock, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.