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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 29 June 2014
Main ID:  DRKS00000444
Date of registration: 16/06/2010
Primary sponsor: Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Carl Gustav Carus TU Dresden
Public title: Early cognitive behavioural psychotherapy in subjects at high risk for bipolar affective disorders
Scientific title: Early cognitive behavioural psychotherapy in subjects at high risk for bipolar affective disorders
Date of first enrolment: 01/10/2010
Target sample size: 100
Recruitment status: Pending
URL:  http://www.drks.de/DRKS00000444
Study type:  interventional
Study design:  Allocation: Randomized controlled trial;. Masking: Double or multiple blind. Control: Active control. Assignment: Parallel. Study design purpose: Prevention;  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria: positive family history of affective or schizoaffective disorders
psychosocial impairment
affective symptomatology

Exclusion criteria: History of manic episode of at least 4 days, psychosis of at least 7 days, main symptomatology must not be present solely within the context of personality disorder or cyclothymia, organic brain disorder, acute suicidality, severe unstable medical condition, intakte of psychotropic medication apart from execptions

Age minimum: 15 Years
Age maximum: 30 Years
Gender: Both, male and female
Health Condition(s) or Problem(s) studied
F31 - Bipolar affective disorder
Intervention(s)
Intervention 1: cognitive behavioural therapy in group setting
14 sessions á 90 minutes, once a week,
adapted manual for risk population (content among ohters psychoeducation, stress management, mindfulness, cognitive habits) Intervention 2: unstructured group setting, again once a week 90 minutes for 14 weeks, study participants stimulate discussios/topics, group leader does involve himself only very limited, interaction will be assessed using recordings of the sessions
Primary Outcome(s)
(1) psychosocial funtioning (at end of intervention, week 14; SIS)
(2) affective symptomatology at end of intervention (at end of intervention, week 14; HAMD, YMRS, EPIMaP, BPSS-P)
Secondary Outcome(s)
(1) stress management (at week 7, 14, 24, 52, 78 using ABF, TICS, SRS, UBV, FERUS)
(2) conversion to bipolar disorders
Secondary ID(s)
EK 60022010
Source(s) of Monetary Support
DFG
Secondary Sponsor(s)
Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Carl Gustav Carus TU Dresden
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