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Main
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Note: This record shows only 22 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. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00000444 |
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Date of registration:
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16/06/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Early cognitive behavioural psychotherapy in subjects at high risk for bipolar affective disorders
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Scientific title:
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Early cognitive behavioural psychotherapy in subjects at high risk for bipolar affective disorders |
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Date of first enrolment:
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01/10/2010 |
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Target sample size:
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100 |
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Recruitment status: |
Pending |
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URL:
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http://drks.de/search/en/trial/DRKS00000444 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: prevention
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Andrea
Pfennig |
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Address:
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Fetscherstraße 74
01307
Dresden
Germany |
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Telephone:
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0351-458-3946 |
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Email:
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andrea.pfennig@uniklinikum-dresden.de |
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Affiliation:
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Klinik und Poliklinik für Psychiatrie und Psychotherapie
Universitätsklinikum Carl Gustav Carus
TU Dresden |
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Name:
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Andrea
Pfennig |
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Address:
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Fetscherstraße 74
01307
Dresden
Germany |
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Telephone:
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0351-458-3946 |
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Email:
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andrea.pfennig@uniklinikum-dresden.de |
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Affiliation:
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Klinik und Poliklinik für Psychiatrie und Psychotherapie
Universitätsklinikum Carl Gustav Carus
TU Dresden |
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Key inclusion & exclusion criteria
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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:
All
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Health Condition(s) or Problem(s) studied
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F31
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Bipolar affective disorder
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Intervention(s)
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Group 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)
Group 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
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Primary Outcome(s)
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(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)
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Secondary Outcome(s)
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(1) stress management (at week 7, 14, 24, 52, 78 using ABF, TICS, SRS, UBV, FERUS)
(2) conversion to bipolar disorders
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Source(s) of Monetary Support
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DFG
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Ethics review
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Status: Approved
Approval date: 31/03/2010
Contact:
ethikkommission@mailbox.tu-dresden.de
Ethikkommission an der TU Dresden
+49-351-4582992
ethikkommission@mailbox.tu-dresden.de
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