Early cognitive behavioural psychotherapy in subjects at high risk for bipolar affective disorders
Organizational Data
- DRKS-ID:
- DRKS00000444
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2010-06-16
- Last update in DRKS:
- 2010-06-16
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Bipolar (manic-depressive) affective disorders are serious psychiatric disorders with enormous impact for the patients and substantial consequences for relatives and the society. Frequently the disease is recognised late with delayed adequate treatment. Patients usually get ill in adolescence or early adulthood, frequently first symptoms are experienced already before that. Compared to the situation in somatic medicine there has been relatively little research into early identification and intervention in patients at risk for bipolar disorders. The aim of the multicentre randomised clinical trial EarlyCBT is to assess the effects of early CBT treatment in subjects at risk for the development of biplar disorders. The duration of the study is 3 years, each participant is followed at least for 18 months. Treatment is provided once a week for the first 14 weeks (sesssions á 90 minutes). Study participants will be randomised to the two arms of the study. One part of the participants attends group sessions of specific cognitive behavioural therapy. Among other things they learn specific techniques to manage stress and early signs of bipolar disorders. The other part of participants attend unstructured group neetings. The study primarly assesses wether early CBT is superior to the control in influencing psychosocial functioning and affective symptomatology. The study will be conducted in five german study centres. An international expert panel supports and accompanies the study.
Brief summary in scientific language
Bipolar affective disorders are serious psychiatric disorders with enormous impact for the patients and substantial consequences for relatives and the society. Frequently the disease is recognised late with delayed adequate treatment. Patients usually get ill in adolescence or early adulthood, frequently first symptoms are experienced already before that. Compared to the situation in somatic medicine there has been relatively little research into early identification and intervention in patients at risk for bipolar disorders. The aim of the multicentre randomised clinical trial EarlyCBT is to assess the effects of early CBT treatment in subjects at risk for the development of biplar disorders. The duration of the study is 3 years, each participant is followed at least for 18 months. Treatment is provided once a week for the first 14 weeks (sesssions á 90 minutes). Study participants will be randomised to the two arms of the study. One part of the participants attends group sessions of specific cognitive behavioural therapy. Among other things they learn specific techniques to manage stress and early signs of bipolar disorders. The other part of participants attend unstructured group neetings. Study participants, rater and stastistician are blinded. The study primarly assesses wether early CBT is superior to the control in influencing psychosocial functioning and affective symptomatology. The study will be conducted in five german study centres. An international expert panel supports and accompanies the study.
Health condition or problem studied
- ICD10:
- F31 - Bipolar affective disorder
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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)
- Arm 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
Endpoints
- Primary outcome:
- (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:
- (1) stress management (at week 7, 14, 24, 52, 78 using ABF, TICS, SRS, UBV, FERUS) (2) conversion to bipolar disorders
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- 2010-10-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 15 Years
- Maximum Age:
- 30 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Carl Gustav Carus TU DresdenProf. Dr. med. Dr. rer. nat. Michael BauerFetscherstraße 7401307 DresdenGermany
- Telephone:
- 0351-458-2760
- Fax:
- 0351-458-4324
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Secondary Sponsor
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Carl Gustav Carus TU DresdenProf. Dr. med. Andrea PfennigFetscherstraße 7401307 DresdenGermany
- Telephone:
- 0351-458-3946
- Fax:
- 0351-458-4324
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Scientific Queries
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Carl Gustav Carus TU DresdenProf. Dr. med. Andrea PfennigFetscherstraße 7401307 DresdenGermany
- Telephone:
- 0351-458-3946
- Fax:
- 0351-458-4324
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Universitätsklinikum Carl Gustav Carus TU DresdenProf. Dr. med. Andrea PfennigFetscherstraße 7401307 DresdenGermany
- Telephone:
- 0351-458-3946
- Fax:
- 0351-458-4324
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- DFGKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der TU DresdenFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49-351-4582992
- Fax:
- +49-351-4584369
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2010-02-04
- Ethics committee number:
- EK 60022010
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2010-03-31
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry