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

在精神分裂症中，临床高危人群的新数据支持在精神病症状完全出现之前进行治疗的益处，与此相反，对双相情感障碍风险患者的早期识别和干预的研究相对较少。包括压力管理在内的认知行为心理疗法被证明对单极抑郁症和双相情感障碍都有效。然而，这种干预在情感性障碍，特别是双相情感障碍高风险受试者中的有效性和不良事件的证据几乎缺失（Pfennig et al. 2012, Pfennig et al. 2013）。在正在进行的随机对照研究中，对德累斯顿、波鸿、科隆、汉堡和柏林各院系早期识别中心的所有受试者进行筛查。此外，在所有参与中心的双相情感障碍专科门诊和门诊部，如果患者有亲属（在建议的年龄组中有一级或二级亲属），则与这些亲属接触，让他们参与筛查过程。根据研究方案确定并同意参与的高风险受试者被随机分为干预组（特定心理治疗组干预）或对照组（非结构化小组会议）。干预包括14次会议<e:1> 90分钟。随访评估将在第7、14、24、52和78周进行。该研究的ITT分析的主要疗效终点是14周时的社会访谈时间表（SIS）评分，该访谈旨在评估八个角色领域（住房、职业/家务/其他社会角色、经济状况、休闲/社会活动、与亲戚的互动、家庭互动、独居、婚姻/伴侣关系和父母/子女管理）的社会心理功能障碍。另一个主要终点是14周时情感症状的变化，测量方法为双相情感障碍（由德累斯顿中心开发的前驱症状问卷，Leopold等人，2012年）和BPSS-P（双相情感障碍前驱症状量表-前瞻性，Correll等人，2013年）。次要终点包括对压力的感知、反应和应对以及发展为双相情感障碍的比率。该研究的结果可用于建立双相情感障碍的预防策略，从风险-收益的角度考虑受试者的风险概况。

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.