Early cognitive behavioural psychotherapy in subjects at high risk for bipolar affective disorders (Acronym: EarlyCBT)

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In contrast to schizophrenia where emerging data in clinical high-risk groups support the benefits of treatment before full psychotic symptoms have emerged, there has been relatively little research into early identification and intervention in patients at risk for bipolar disorders. Cognitive behavioural psychotherapy including stress management was shown to be effective in both unipolar depressive and bipolar disorders. However, evidence of the effectiveness and adverse events of such intervention in subjects at high risk for affective disorders, and especially for bipolar disorders, is almost missing (Pfennig et al. 2012, Pfennig et al. 2013).In the ongoing randomized controlled study, all subjects seen at the early recognition centres at the departments in Dresden, Bochum, Cologne, Hamburg and Berlin are screened. Additionally, patients of the bipolar-specific in- and outpatient departments of all participating centres that have relatives (1st or 2nd degree, in the proposed age group) are approached for participation of these relatives in the screening process. Subjects identified as being at high risk according to the study protocol that consent to participation are randomized to the intervention (specific psychotherapeutic group intervention) or control (unstructured group meetings). The interventions consists of 14 sessions á 90 minutes. Follow-up assessments will take place at weeks 7, 14, 24, 52 and 78.The primary efficacy endpoint in the ITT analysis of the study is the Social Interview Schedule (SIS) score at 14 weeks, an interview that was designed to assess impairment in psychosocial functioning in eight role areas (housing, occupation/housework/other social roles, economic situation, leisure/social activities, interaction with relatives, domestic interactions, living alone, marital/partnership and parental/child management). An additional primary endpoint is the change in affective symptomatology at 14 weeks measured by EPIbipolar (Prodrome questionnaire developed by the centre Dresden, Leopold et al. 2012) and the BPSS-P (Bipolar Prodrome Symptom Scale – prospective, Correll et al. 2013). Secondary endpoints include perception of, reaction to and coping with stress and the rate of developing bipolar disorder.The results of the study could be used to establish preventive strategies for bipolar disorders that areadequate from the risk-benefit perspective to the risk profile of the subjects.