Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.
Departamento de Psiquiatría, Universidad Autónoma de Madrid, Madrid, Spain.
BMC Psychiatry. 2020 Jan 29;20(1):30. doi: 10.1186/s12888-020-2431-x.
Although insight in schizophrenia spectrum disorders (SSD) has been associated with positive outcomes, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight suggests that metacognitive training (MCT) may improve insight and clinical outcomes in SSD, although this remains to be established.
This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the efficacy of MCT for improving insight (primary outcome), including clinical and cognitive insight, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Scale (BCIS), respectively, in (at least) n = 126 outpatients with SSD at three points in time: i) at baseline (T0); ii) after treatment (T1) and iii) at 1-year follow-up (T2). SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes at T1 and T2, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants.
To the best of our knowledge, this will be the first RCT testing the effect of group MCT on multiple insight dimensions (as primary outcome) in a sample of unselected patients with SSD, including several secondary outcomes of clinical relevance, namely symptom severity, functioning, which will also be evaluated with EMA, hospitalizations and suicidal behaviour.
ClinicalTrials.gov: NCT04104347. Date of registration: 26/09/2019 (Retrospectively registered).
尽管精神分裂症谱系障碍（SSD）的洞察力与积极结果相关，但迄今为止，先前治疗对洞察力的影响的效果大小相对较小。洞察力的元认知基础表明，元认知训练（MCT）可能改善 SSD 的洞察力和临床结果，尽管这仍有待确定。
这是一项单中心、评估者盲、平行组、随机临床试验（RCT），旨在研究 MCT 改善洞察力（主要结果）的疗效，包括临床和认知洞察力，这将分别通过时间表进行评估洞察力（扩展版）（SAI-E）和贝克认知量表（BCIS），在至少 126 名 SSD 门诊患者中在三个时间点进行：i）基线（T0）；ii）治疗后（T1）和 iii）1 年随访（T2）。接受 MCT 的 SSD 患者和参加非干预支持小组的对照组将在 T1 和 T2 时根据基线数据比较洞察力水平变化和几个临床和认知次要结果，同时调整基线数据。生态瞬时评估（EMA）将进行试点评估参与者的功能。
据我们所知，这将是第一项 RCT 测试团体 MCT 对未选择的 SSD 患者样本中多个洞察力维度的影响（作为主要结果），包括几个具有临床相关性的次要结果，即症状严重程度、功能，也将使用 EMA 进行评估，住院和自杀行为。
ClinicalTrials.gov：NCT04104347。注册日期：2019 年 9 月 26 日（回顾性注册）。
