title: Early specific cognitive-behavioural psychotherapy in subjects at high risk for bipolar disorders: study protocol for a randomised controlled trial.
abstract: 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 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  WHO International Clinical Trials Platform (ICTRP), identifier: DRKS00000444, date of registration: 16 June 2010.
authors.affiliation: Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Fetscherstrasse 74, 01307 Dresden, Germany. andrea.pfennig@uniklinikum-dresden.de.
authors.forename: Andrea
authors.initials: A
authors.lastname: Pfennig
authors.forename: Karolina
authors.initials: K
authors.lastname: Leopold
authors.forename: Andreas
authors.initials: A
authors.lastname: Bechdolf
authors.forename: Christoph U
authors.initials: CU
authors.lastname: Correll
authors.forename: Martin
authors.initials: M
authors.lastname: Holtmann
authors.forename: Martin
authors.initials: M
authors.lastname: Lambert
authors.forename: Carolin
authors.initials: C
authors.lastname: Marx
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Meyer
authors.forename: Steffi
authors.initials: S
authors.lastname: Pfeiffer
authors.forename: Andreas
authors.initials: A
authors.lastname: Reif
authors.forename: Maren
authors.initials: M
authors.lastname: Rottmann-Wolf
authors.forename: Natalie M
authors.initials: NM
authors.lastname: Schmitt
authors.forename: Thomas
authors.initials: T
authors.lastname: Stamm
authors.forename: Georg
authors.initials: G
authors.lastname: Juckel
authors.forename: Michael
authors.initials: M
authors.lastname: Bauer
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D001714:Bipolar Disorder / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D042241:Early Diagnosis; D061345:Early Medical Intervention; D005858:Germany; D006801:Humans; D064866:Mindfulness; D011237:Predictive Value of Tests; D011340:Problem Solving; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013315:Stress, Psychological / Q000150:complications / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult