Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.
Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.
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与像往常一样的治疗方法相比，住院抑郁症治疗后，对亲戚的短暂心理教育群体干预对患者的疾病进程的有效性 - 多站点随机对照试验的研究方案。
DOI：
10.1186/s12888-015-0633-4
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发表时间：
2015-10-23
期刊：
影响因子：
4.4
通讯作者：
Hölzel LP
中科院分区：
文献类型：
--
作者：
Frank F;Wilk J;Kriston L;Meister R;Shimodera S;Hesse K;Bitzer EM;Berger M;Hölzel LP
在抑郁症的急性住院治疗后，复发和再次住院是很常见的。迫切需要采取干预措施来稳定治疗结果。对亲属的心理教育团体干预适合于改善精神分裂症和双相情感障碍的病程。日本的一项小型单中心随机对照试验也显示了治疗抑郁症的有希望的结果。然而，有关抑郁症患者亲属的心理教育的证据尚不清楚。这项研究是作为一项双臂多点随机对照试验进行的，目的是评估与常规治疗相比，对亲属进行短暂的心理教育团体干预作为维持治疗对病程的递增效果。主要结果是估计患者在出院后一年内无抑郁的天数。180名被诊断为单相抑郁障碍的患者以及每名患者的一名关键亲属将在住院治疗期间被纳入，并随机分配到出院时的情况。在干预组，患者出院后，亲属将参加简短的心理教育小组干预。干预由四个小组会议组成，每个小组会议持续90至120分钟。每一次小组会议都包含信息部分以及解决问题的系统培训。在这两种研究条件下，患者都将像往常一样接受治疗。在出院时、出院后3个月、6个月、9个月和12个月对患者及其亲属进行问卷调查。除了主要结果外，还将考虑几个与患者相关和相对相关的次要结果，并对卫生经济学进行调查。我们的研究将提供证据，证明在住院抑郁症治疗后，对亲属进行短暂的心理教育干预作为维持治疗的增量效果。积极的结果可能会对抑郁症的医疗保健产生重大影响。德国临床试验注册(DRKS)：DRKS00006819；试验注册日期：2014 Oktober 31；通用试验编号(UTN)：U1111-1163-5391
Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear. The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient’s discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated. Our study will provide evidence on the incremental effect of a brief psychoeducational intervention for relatives as a maintenance treatment after inpatient depression treatment. Positive results may have a major impact on health care for depression. German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391