PEER: Peer Support for Severe Mental Disorders

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Completed
CT.gov ID
NCT02276469
Collaborator
German Federal Ministry of Education and Research (Other)
200
2
41

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: peer support
N/A

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 Design

Study Type:
Interventional
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 :
Jul 1, 2011
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Self-Efficacy at 6 month [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 [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 [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 [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 [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 [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 [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 [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 [one year before, until one year past intervention]

    The days of in patient care assessed from the clinical records

  9. Days to hospitalization [Baseline until 12 month follow up]

    Days to hospitalization after the beginning of treatment assessed from the clinical records

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder
Exclusion Criteria:
  • primary clinical diagnosis of addiction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitätsklinikum Hamburg-Eppendorf
  • German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Thomas Bock, Prof. Dr., University Medical Center Hamburg-Eppendorf (UKE)

Study Documents (Full-Text)

None provided.

More Information

Publications

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
First Posted:
Oct 28, 2014
Last Update Posted:
Jan 5, 2015
Last Verified:
Jan 1, 2015
Keywords provided by Prof. Dr. Thomas Bock, Prof.Dr., Universitätsklinikum Hamburg-Eppendorf
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2015