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Completed

NCT Number: NCT02276469

Peer Support for Severe Mental Disorders

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

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Key information

Conditions

Psychosis Bipolar Disorder Bipolar and Related Disorders Borderline Personality Disorder Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders Personality Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • primary clinical diagnosis of addiction

Treatment and study plan

Peer Support

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study 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

Acronym: PEER

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2014
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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