与常规治疗相比，针对亲属的简短心理教育小组干预对住院抑郁症治疗后患者病程的有效性——一项多中心随机对照试验的研究方案

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.

作者信息

Frank Fabian, Wilk Juliette, Kriston Levente, Meister Ramona, Shimodera Shinji, Hesse Klaus, Bitzer Eva-Maria, Berger Mathias, Hölzel Lars P

机构信息

Department of Psychiatry and Psychotherapy, Research Group Psychotherapy and Health Services Research, Medical Center - University of Freiburg, Hauptstraße 5, D-79104, Freiburg, Germany.

Department of Public Health and Health Education, University of Education Freiburg, Kunzenweg 21, D-79117, Freiburg, Germany.

出版信息

BMC Psychiatry. 2015 Oct 23;15:259. doi: 10.1186/s12888-015-0633-4.

DOI:10.1186/s12888-015-0633-4

PMID:26497218

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4619254/

Abstract

BACKGROUND

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.

METHODS/DESIGN: 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.

DISCUSSION

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.

TRIAL REGISTRATION

German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391.

摘要

背景

抑郁症急性住院治疗后复发和再次住院很常见。迫切需要稳定治疗效果的干预措施。针对亲属的心理教育团体干预已被证明适用于改善精神分裂症和双相情感障碍的病程。一项小型日本单中心随机对照试验对抑郁症也显示出有希望的结果。然而，关于抑郁症患者亲属心理教育的证据尚不清楚。

方法/设计：本研究作为一项双臂多中心随机对照试验进行，以评估与常规治疗相比，针对亲属的简短心理教育团体干预作为维持治疗对病程的增量效果。主要结局是患者从住院治疗出院后一年内无抑郁天数的估计值。180例被诊断为单相抑郁症的患者以及每位患者的一名主要亲属将在住院治疗期间纳入，并在出院时随机分配至不同组。在干预组中，亲属将在患者出院后参加简短的心理教育团体干预。该干预包括四个小组会议，每个会议持续90至120分钟。每个小组会议都包含信息部分以及解决问题的结构化培训。在两种研究条件下，患者都将接受常规治疗。患者和亲属将在出院时以及出院后3、6、9和12个月通过问卷调查进行调查。除主要结局外，还将考虑几个与患者相关和与亲属相关的次要结局，并对卫生经济学进行调查。