Peer Support for Severe Mental Disorders

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

Detailed Description
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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.

Official Title
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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

Conditions
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Psychosis, Major Depression, Bipolar Disorder, Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: peer support


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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peer support<br>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<br>* 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<br>|
| No Intervention: usual care<br>usual care was delivered to the patients | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe mental illness