辅助心理治疗在双相情感障碍早期的应用：一项随机对照试验的研究方案。

Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.

机构信息

Department of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.

Department of Psychiatry and Psychotherapy, Charité University Medicine, Berlin, Germany.

出版信息

Trials. 2020 Oct 13;21(1):845. doi: 10.1186/s13063-020-04755-8.

DOI:10.1186/s13063-020-04755-8

PMID:33050952

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7552468/

Abstract

BACKGROUND

Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted, tailored early interventions in particular may improve disease prognosis. The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.

METHODS

In this multicenter randomized controlled trial (RCT), 300 patients with bipolar disorder are randomized to one of two group psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group). Each therapy comprises of a total of 48-h sessions (delivered once a month) over a period of 4 months. Assessments take place at baseline (t1); 6 months follow-up, i.e., post-intervention (t2); 12 months follow-up (t3); and 18 months follow-up (t4), whereby 18 months follow-up is the primary time point of interest.

DISCUSSION

The goal of this study is to test the effects of an innovative, specific group therapy relative to an active control condition in terms of rates of relapse, global functioning, and neuropsychological functioning. Pending the outcomes of the trial, it will be possible to establish a firm evidence base for accessible group psychotherapy adjuvant to routine psychiatric care for individuals with bipolar disorder.

TRIAL REGISTRATION

USA: ClinicalTrials.gov NCT02506322 . Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013 . Registered on21 May 2015.

摘要

背景

双相情感障碍是一种具有慢性病程和高复发率的严重疾病。通常，双相情感障碍在青少年或成年早期发作，患者会因此疾病而承受重大的个人和社会成本。尽管如此，迄今为止，关于在疾病的关键阶段（例如，早期发病）进行心理治疗的有效性的证据有限（对照）。一些初步研究表明，特别是针对特定的、量身定制的早期干预措施可能会改善疾病预后。拟议的研究检查了团体心理治疗对预防双相情感障碍早期复发、整体适应功能和神经认知功能的有效性。

方法

在这项多中心随机对照试验（RCT）中，将 300 名双相情感障碍患者随机分为两组团体心理治疗之一：特定情感认知治疗（SECT；干预组）或情绪焦点支持治疗（EFST；活性对照组）。两种疗法均包含共 48 个小时的疗程（每月一次），为期 4 个月。评估在基线（t1）；6 个月随访，即干预后（t2）；12 个月随访（t3）；18 个月随访（t4），其中 18 个月随访是主要关注时间点。