NCT02276469

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 5, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

October 9, 2014

Last Update Submit

January 1, 2015

Conditions

PsychosisMajor DepressionBipolar DisorderBorderline Personality Disorder

Keywords

severe mental illness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • 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

  • Service satisfaction after six month of intervention

    After six month intervention

  • 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

  • Change from Baseline in Psychosocial functioning at 6 and 12 month

    1. Baseline; 2. Six month follow up (post intervention) 3. Twelve month follow

  • +4 more secondary outcomes

Study Arms (2)

peer support

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

Behavioral: peer support

usual care

NO INTERVENTION

usual care was delivered to the patients

Interventions

peer supportBEHAVIORAL

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

peer support

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • primary clinical diagnosis of addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    BACKGROUND

  • 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.

    PMID: 10109801BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 8767546BACKGROUND

  • Sass, H., Wittchen, H.U., Zaudig, M. (2001). Diagnostisches und Statistisches Manual psychischer Störungen DSM-IV. Göttingen, Bern, Toronto, Seattle: Hogrefe Verlag für Psychologie

    BACKGROUND

  • 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.

    PMID: 20552540BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersDepressive Disorder, MajorBipolar DisorderBorderline Personality DisorderMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersDepressive DisorderMood DisordersBipolar and Related DisordersPersonality Disorders

Study Officials

  • Thomas Bock, Prof. Dr.

    University Medical Center Hamburg-Eppendorf (UKE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 28, 2014

Study Start

July 1, 2011

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 5, 2015

Record last verified: 2015-01