跳至主要内容
临床试验/NCT04593537
NCT04593537已完成不适用

Measuring Self-blame-related Action Tendencies and Prediction of Prognosis in Major Depressive Disorder

King's College London1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Self-rated Quick Inventory of Depressive Symptomatology -16

研究概览

简要总结

Predicting the prognosis and treatment responses in individuals with major depressive disorder (MDD) is currently based on trial and error, because some treatments work for some individuals, but not others. Novel predictors of prognosis and treatment response in MDD can add value to the development of targeted treatments and the stratified approaches to improve long-term outcomes of individuals with MDD. This study uses a novel virtual-reality-based measure of blame-related action tendencies and combines this with established predictors of treatment response and prognosis in individuals with MDD.

详细描述

Developing clinical and psychological markers which characterise the large subgroup of patients with major depression who do not benefit from serotonergic antidepressants offered as first line treatment is of utmost clinical importance but has so far not been achieved. Clinical and psychological indicators would be ideal in predicting non-response to antidepressant medications, given their wide availability. So far, however, these measures have failed to provide accurate predictions at the individual level. Novel predictors of prognosis and treatment response in major depressive disorder (MDD) can add value to the development of targeted treatments and stratified approaches to improve long-term outcomes of individuals with MDD.

The psychological underpinnings of patients' response to treatment have been an important direction of research. As proposed by the revised learned helplessness model, one central cognitive vulnerability to MDD is the tendency to excessively blame oneself for negative events occurring in one's life. Consistent with the theory, previous studies have demonstrated the importance of self-blaming bias both as a vulnerability factor and as a symptom of depression. For example, it has been shown that individuals with remitted MDD had increased self-contempt biases compared to healthy control participants in a recent study. As MDD is a life-long diagnosis, understanding the differences between remitted MDD and healthy controls could help to identify vulnerability traits associated with MDD. Thus, the finding of self-blaming biases in remitted MDD demonstrate the potential role of self-blame as a vulnerability trait and a novel cognitive marker for MDD that remain present during remission and possibly constitute vulnerability for recurrence. However, one limitation in previous studies is that people might have experienced difficulties distinguishing their moral emotions such as shame and guilt under certain circumstances. Previous measures assessing these emotions largely depended on participants' subjective rating and are thus problematic in terms of differentiating the moral emotions.

In addition, these measures fail to address the adaptive or maladaptive nature of moral emotions. As proposed by Tangney, moral emotions can be either adaptive and maladaptive, and this difference is possibly determined by an individual's different action tendencies associated with their moral emotions. Action tendencies describe an implicit cognitive and motivational state before an action is taken. It was suggested that adaptive action tendencies, such as feeling like apologizing, were associated with self-blaming emotions such as guilt, and maladaptive action tendencies such as feeling like hiding and creating a distance from oneself were associated with shame. However, an empirical investigation of the associations between action tendencies and self-blaming emotions is lacking. Further investigations of this topic are important for understanding the potential role of action tendencies as a novel measure of self-blame and its association to the vulnerability to MDD. It is important to develop measures of action tendencies with a high ecological validity. In previous studies, our research group has developed a computerised task that measures action tendencies and used it to predict prognosis in MDD. It was found that this task can predict recurrence risk in people with MDD, showing a large effect size (Cohen's d=.96). However, there were two major limitations. First, the task used in a verbal format and included abstract descriptions of scenarios (e.g. "You act stingily towards your friend"), which makes the task dependent on how well participants can imagine the scenarios. Second, the lack of immersiveness of the task made it difficult to engage, which may limit the task's ecological validity.

Virtual reality (VR)-based assessment is a new paradigm for cognitive evaluation compared to the traditional paper-and-pencil or computerized assessment. VR scenarios were suggested to be promising tools for cognitive assessments and have been demonstrated as safe for the assessment of anxiety disorders and depression. Importantly, the interactive and immersive nature of virtual reality makes it possible to develop a cognitive task that is engaging and has a higher ecologically validity, which would be ideal for identifying novel cognitive markers of MDD outcomes. Thus, this study will aim to employ a virtual reality task to measure blame-related action tendencies.

There are three major research questions of this study

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Self-rated Quick Inventory of Depressive Symptomatology -16

时间窗: Four months

Depressive symptoms assessed by the self-rated Quick Inventory of Depressive Symptomatology sum score. The score ranges from 0 to 27, with a higher score indicating more severe depressive symptoms.

次要结局

  • General Anxiety Disorder-7(Four months)
  • Maudsley-Modified Patient Health Questionniare -9(Four months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验