Clinical trial NCT02276469: Peer Support for Severe Mental Disorders
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Major Depression
Bipolar Disorder
Borderline Personality Disorder
Keywords: severe mental illness
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2014-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* primary clinical diagnosis of addiction

Primary outcomes:
measure: Change from Baseline in Self-Efficacy at 6 month
timeFrame: 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
timeFrame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
measure: Change from Baseline in Quality of life at 6 and 12 month
timeFrame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
measure: Service satisfaction after six month of intervention
timeFrame: After six month intervention
measure: Change from Baseline in Illness management, Coping at 6 and 12 month
timeFrame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
measure: Change from Baseline in Psychosocial functioning at 6 and 12 month
timeFrame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
measure: Change from Baseline in Severity of illness at 6 and 12 month
timeFrame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
measure: Change from Baseline in Illness management, Coping at 6 and 12 month
timeFrame: 1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow
measure: Hospitalization in days of in-patient care
timeFrame: one year before, until one year past intervention
measure: Days to hospitalization
timeFrame: Baseline until 12 month follow up
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf (UKE)
name: Thomas Bock, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: Muthny FA. [References for evaluation scales in quality assurance in rehabilitation--6. Assessment of coping processes with the Freiburg Questionnaire of Illness Coping]. Rehabilitation (Stuttg). 1996 May;35(2):IX-XVI. German.
citation: Sass, H., Wittchen, H.U., Zaudig, M. (2001). Diagnostisches und Statistisches Manual psychischer Störungen DSM-IV. Göttingen, Bern, Toronto, Seattle: Hogrefe Verlag für Psychologie
citation: Bock T, Brysinski T, Klapheck K, Bening U, Lenz A, Naber D. [On subjective meaning of psychoses. Construction, validation and first application of a new questionnaire--the SuSi-Project (Hamburg)]. Psychiatr Prax. 2010 Sep;37(6):285-91. doi: 10.1055/s-0030-1248424. Epub 2010 Jun 15. German.