Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-18 @ 2:58 AM
Study NCT ID:
NCT02276469
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2014-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer Support for Severe Mental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D001883', 'term': 'Borderline Personality Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-01', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-24', 'lastUpdatePostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Self-Efficacy at 6 month', 'timeFrame': '1. Baseline; 6 month follow up (post intervention); twelve month follow', 'description': 'General Self-Efficacy Scale; Self report Questionnaire; 10 Items'}], 'secondaryOutcomes': [{'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', 'description': 'Self report questionnaires: Modulares System zur Lebensqualität MSLQ-R'}, {'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', 'description': 'Self report questionnaires: EuroQol-Group: EQ5D'}, {'measure': 'Service satisfaction after six month of intervention', 'timeFrame': 'After six month intervention', 'description': 'Self report questionnaire: Client Satisfaction Questionnaire CSQ 8'}, {'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', 'description': 'FKV-LIS Freiburger Self report questionnaire: Fragebogen zur Krankheitsverarbeitung; examining coping strategies'}, {'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', 'description': 'Clinical observation: Global assessment of functioning DSM'}, {'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', 'description': 'Clinical observation: Clinical global impression'}, {'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', 'description': 'Self report questionnaire: Subjective sense of psychosis'}, {'measure': 'Hospitalization in days of in-patient care', 'timeFrame': 'one year before, until one year past intervention', 'description': 'The days of in patient care assessed from the clinical records'}, {'measure': 'Days to hospitalization', 'timeFrame': 'Baseline until 12 month follow up', 'description': 'Days to hospitalization after the beginning of treatment assessed from the clinical records'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe mental illness'], 'conditions': ['Psychosis', 'Major Depression', 'Bipolar Disorder', 'Borderline Personality Disorder']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', '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."}, {'pmid': '10109801', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '8767546', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}, {'pmid': '20552540', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine wether peer support is effective for the treatment of people with severe mental illness.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of schizophrenia, unipolar depression, bipolar disorder, personality disorder\n\nExclusion Criteria:\n\n* primary clinical diagnosis of addiction'}, 'identificationModule': {'nctId': 'NCT02276469', 'acronym': 'PEER', 'briefTitle': 'Peer Support for Severe Mental Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SC 0748/006'}, 'secondaryIdInfos': [{'id': 'Psychenet Teilprojekt 5', 'type': 'OTHER', 'domain': 'University medicalcenter hamburg-eppendorf'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'peer support', 'description': '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', 'interventionNames': ['Behavioral: peer support']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'usual care was delivered to the patients'}], 'interventions': [{'name': 'peer support', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['peer support']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas Bock, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Hamburg-Eppendorf (UKE)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Prof. Dr. Thomas Bock', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}