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

对双相情感障碍高危人群进行早期认知行为心理治疗（缩写：EarlyCBT）

基本信息

批准号：
130211207
负责人：
Professor Dr. Michael Bauer
金额：
--
依托单位：
Klinik für Psychiatrie, Psychotherapie und Psychosomatik
依托单位国家：
德国
项目类别：
Clinical Trials
财政年份：
2010
资助国家：
德国
起止时间：
2009-12-31 至 2018-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/130211207?language=en
关键词：
Early cognitive behavioural psychotherapy subjects

项目摘要

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.

与精神分裂症不同的是，在精神分裂症的临床高危人群中，新出现的数据支持在精神分裂症症状完全出现之前进行治疗的好处，而对于有双相情感障碍风险的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治疗被证明对单相抑郁和双相情感障碍都有效。然而，这种干预在情感障碍，特别是双相情感障碍高危人群中的有效性和不良事件的证据几乎是缺失的(Pfennig等人。2012年，Pfennig等人。在正在进行的随机对照研究中，对在德累斯顿、波鸿、科隆、汉堡和柏林各部门的早期识别中心看到的所有受试者进行了筛查。此外，还与有亲属(建议的年龄组为一级或二级)的所有参与中心的躁郁症专科和门诊部的患者接洽，要求这些亲属参与筛查过程。根据研究方案被确定为高危的受试者被随机分为干预组(特定的心理治疗组干预)或对照组(非结构化小组会议)。干预包括14次会议，90分钟。跟踪评估将在第7、14、24、52和78周进行。ITT分析中的主要疗效终点是14周时的社会访谈计划(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/伙伴关系和父母/子女管理)的心理社会功能损害。另一个主要终点是14周时情绪症状学的变化，由EPIbipolal(由德累斯顿中心，Leopold等人开发的前驱症状问卷)测量。2012)和BPSS-P(双相先兆症状量表-前瞻性，Correll等人)。2013年)。次级终点包括对压力的感知、反应和应对，以及双相情感障碍的发生率。这项研究的结果可以用来建立双相情感障碍的预防策略，从风险-收益的角度来看，这些策略足以满足受试者的风险状况。