Early specific cognitive-behavioural psychotherapy in subjects at high risk for bipolar disorders: study protocol for a randomised controlled trial

Please always quote using this URN: urn:nbn:de:bvb:20-opus-116279
  • Background: Bipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adultsBackground: Bipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adults seek help, and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school, training, at work and in their social relationships. We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy (CBT) in this subpopulation. Methods/Design: EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT, including stress management and problem solving strategies, with elements of mindfulness-based therapy (MBT) versus unstructured group meetings for 14 weeks each and follow-up until week 78. Participants are recruited at seven university hospitals throughout Germany, which provide in-and outpatient care (including early recognition centres) for psychiatric patients. Subjects at high risk must be 15 to 30 years old and meet the combination of specified affective symptomatology, reduction of psychosocial functioning, and family history for (schizo) affective disorders. Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14 weeks between groups. Secondary endpoints include the above mentioned endpoints at 7, 24, 52 and 78 weeks and the change within groups compared to baseline; perception of, reaction to and coping with stress; and conversion to full BD. Discussion: To our knowledge, this is the first study to evaluate early specific CBT in subjects at high risk for BD. Structured diagnostic interviews are used to map the risk status and development of disease. With our study, the level of evidence for the treatment of those young patients will be significantly raised.show moreshow less

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Author: Andrea Pfennig, Karolina Leopold, Andreas Bechdolf, Christoph U. Correll, Martin Holtmann, Martin Lambert, Carolin Marx, Thomas D. Meyer, Steffi Pfeiffer, Andreas Reif, Maren Rottmann-Wolf, Natalie M. Schmitt, Thomas Stamm, Georg Juckel, Michael Bauer
URN:urn:nbn:de:bvb:20-opus-116279
Document Type:Journal article
Faculties:Medizinische Fakultät / Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie
Language:English
Parent Title (English):TRIALS
ISSN:1468-6694
ISSN:1745-6215
Year of Completion:2014
Volume:15
Issue:161
Source:Trials 2014 15:161. doi:10.1186/1745-6215-15-161
DOI:https://doi.org/10.1186/1745-6215-15-161
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/24886581
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Tag:bipolar disorders; cognitive-behavioural psychotherapy; early intervention; early recognition; intervention study; of-the-literature; rating scale; spectrum disorder; ultra-high risk
Release Date:2015/07/30
Licence (German):License LogoCC BY: Creative-Commons-Lizenz: Namensnennung