Metacognitive Training for Negative Symptoms (MCT Minus)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The Motivation and Pleasure Scale- Self-Report (MAP-SR) (Llerena et al., 2013)
研究概览
简要总结
There is a clear rationale for developing interventions targeting negative symptoms of schizophrenia as these are a stronger indicator of current and future functioning than positive symptoms and because they respond poorly to medication and existing psychological interventions. This is reflected in the NIMH-MATRICS consensus statement that emphasised that persistent negative symptoms represent an unmet therapeutic need for patients suffering from schizophrenia.
The purpose of this study is to evaluate, in a scientific manner, the intervention developed by Swanson et al. 2021: Metacognitive Training (MCT) Minus. The MCT was adapted to target negative symptoms in psychotic disorders (e.g. schizophrenia, schizoaffective or non-affective functional psychosis) as the original version of the intervention focused exclusively on positive symptoms. The specific aim is to study whether MCT Minus is a promising treatment for the intended population in terms of reductions in negative symptoms, severity of defeatist attitudes, internalised stigma, and depression as well as improvements in reflective ability and overall functioning.
The research will add to existing research by identifying and measuring potential mechanisms of change for negative symptoms (i.e., defeatist attitudes, reflective functioning, stigma and depression). It will also add to the existing evidence base by measuring whether the cognitive biases addressed in MCT lead to changes in the wider conceptualisation of metacognition used elsewhere and whether the promising results seen in the feasibility study of MCT Minus can be replicated in a randomised controlled trial (RCT) with a control group and a blinded assessor. The researchers also hope to replicate the findings of a previous study, where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity.
详细描述
Introduction:
While clinicians tend to focus on positive symptoms as primary treatment targets in schizophrenia, patients prioritize the treatment of depressive and negative symptoms. Persistent negative symptoms are experienced by approximately 20%-40% of individuals diagnosed with schizophrenia. Current research indicates that negative symptoms are independent from positive symptoms, depression, cognitive dysfunctions, and disorganization. However, neither medication nor existing psychosocial interventions have proven to be efficacious in reducing negative symptoms. Consequently, authors have highlighted the need for better understanding of treatment mechanisms underpinning psychological interventions that directly target negative symptoms.
Psychological conceptualizations suggest that negative symptom expression can, in some cases, be understood as a response to adverse experiences. For example, Beck et al.'s cognitive model suggests that negative symptoms emerge from a process where individuals adopt coping strategies of 'shutting down' the cognitive-affective experience. This allows individuals to cope with overwhelming or aversive situations in the short term but leads to a reliance on negative symptoms (including social withdrawal, avolition, and diminished expression) to reduce exposure to, and impact of, negative experiences in the longer term. From an attachment framework, Griffiths and McLeod (2019) suggest that negative symptoms may be seen 'as responses involving emotional and social withdrawal that emerge from threats to self-security'. If negative symptoms can be understood within cognitive and developmental frameworks, it may be possible to develop theoretically driven interventions for their treatment.
A cognitive model of negative symptoms:
Negative symptoms are associated with low expectations of future success, asocial beliefs, a reduced sense of self-efficacy, negative self-concepts, defeatist performance beliefs and self-stigma. The cognitive model therefore proposes that negative symptoms might be caused and maintained by dysfunctional beliefs arising as a consequence of repeated failures and setbacks. These appraisals might include negative beliefs about social affiliations; low expectations of pleasure, success and acceptance; defeatist beliefs about performance; and a perception of limited resources. The self-perception, and perceived self-efficacy, of individuals diagnosed with schizophrenia may also be influenced by self-stigmatizing views of their mental illness. It might be that these factors result in hypervigilance to perceived criticism. Longitudinal studies have shown support for the cognitive model as defeatist performance attitudes and asocial beliefs are found to predict future negative symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18
- •Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis
- •Resident in Region Sörmland, Region Västmanland or Region Uppland
排除标准
- •Evidence of severe organic brain dysfunction
- •Learning disabilities
- •Difficulty with the Swedish language
- •Visual and/or hearing impairment
- •Being unable or unwilling to provide written informed consent
结局指标
主要结局
The Motivation and Pleasure Scale- Self-Report (MAP-SR) (Llerena et al., 2013)
时间窗: 5 minutes
Self-rated questionnaire to assess negative symptoms Minimum value is 0 = better outcome. Maximum value is 90 = worse outcome.
The Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987)
时间窗: 20 minutes
Clinical interview to assess negative symptoms (analysed with the five factor-model) Minimum value is 0 = better outcome. Maximum value is 210 = worse outcome.
The Clinical Assessment Interview for Negative Symptoms (CAINS) (Forbes et al., 2011)
时间窗: 15 minutes
Clincial interview to assess negative symptoms. Minimum value is 0 = better outcome. Maximum value is 52 = worse outcome.
次要结局
- The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) (Hammer & Toland, 2017)(5 minutes)
- The Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington, & Schissel, 1990)(10 minutes)
- The World Health Organization (WHO) Disability Assessment Schedule (WHODAS) 2.0 (WHO, 2010)(10 minutes)
- The Dysfunctional Attitudes Scale (DAS) (Weissman & Beck, 1978)(5 minutes)
- The Reflective Functioning Questionnaire (RFQ-8) (Fonagy et al., 2016)(5 minutes)