Does Metacognitive Training Improve Insight and Clinical Outcomes in Schizophrenia?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Change in cognitive insight
研究概览
简要总结
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 Insight Scale (BCIS), respectively, in (at least) n=126 outpatients with SSD at three points in time: i) at baseline (Time 0); ii) after treatment (Time 1) and iii) at 1-year follow-up (Time 2). 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 after treatment and at follow-up, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants.
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 clinically relevant outcomes, namely symptom severity, functioning, which will also be evaluated with EMA, hospitalizations and suicidal behaviour.
详细描述
INTRODUCTION:
Schizophrenia and related disorders remain associated with relatively poor psychosocial outcomes. Impaired insight has been reported to be the strongest predictor of this poor outcome in psychotic disorders. However, the effect size of previous treatments on insight changes in psychotic disorders has been relatively small to date, which may have been the result of not tackling the actual underpinnings of insight in psychosis.
Several theories have been proposed to explain what underlies 'lack of insight' in schizophrenia spectrum disorders. First, lack of insight could be viewed as having a function in terms of being protective or preserving self-esteem, i.e., a denial mechanism. Second, lack of insight may also be considered as a primary symptom of the disorder. Third, the neurocognitive basis of insight was in part supported by a meta-analysis, which also suggested that other variables, namely metacognition, which was defined as 'the ability to think of one's and others' thinking', may affect insight. Indeed, patients with schizophrenia have been reported to show metacognitive deficits and poorer metacognitive performance is linked with impaired insight in schizophrenia. Metacognitive training (MCT) may therefore improve insight, which should also have a positive impact on clinical outcomes, although no previous randomized clinical trials (RCT) have investigated this.
MCT was first developed by Steffen Moritz and Todd Woodward and is available at no cost at: http://www.uke.de./mct. Since then, one systematic review and four meta-analyses have replicated the positive effects of MCT on positive symptoms, particularly delusions, when compared with 'treatment as usual' (TAU), although one meta-analysis failed to show such an association. However, to the best of our knowledge no definitive randomised clinical trial (RCT) using MCT has considered insight as primary outcome to date, although three previous RCTs found other non-MCT metacognitively oriented therapies to improve insight in first-episode psychosis and schizophrenia.
Clinical and cognitive insight are different, albeit related, concepts. There has been a growing interest in clinical insight in psychosis since the multidimensional model of insight proposed by David, which encompasses three different, albeit overlapping, dimensions - illness recognition, symptom relabelling and treatment compliance - and has been consistently replicated ever since. Multidimensional measurement scales, such as the Scale of Uawareness of Mental Disorder (SUMD) and the Schedule for Assessment of Insight (SAI-E), were also devised for research. Cognitive insight is a core metacognitive domain which refers to the person's ability to evaluate and correct his/her own distorted beliefs and misinterpretations (self-reflectiveness) and the tendency to overconfidence in one's conclusions (self-certainty).
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
- Single (Outcomes Assessor)
盲法说明
After the baseline (Time 0) assessment participants are randomised to either MCT or the control group through a computerized plan (no stratification factors) in blocks of 10 subjects (maximum number of each group) and assessor-patient blind. Only one co-principal investigator of the project (EBG) has access to the randomisation plan, but the assessor (JDLM) is not informed of the patient's allocation arm. Also, big efforts will be made on the ground to reduce the risk that the assessor (JDLM) may become accidentally unblinded and patients are reminded that they should not disclose their group assignment at any time. At the end of the baseline assessment, participants receive an envelope with the intervention assignment from an independent administrator who is not involved in the research team. Hence, assessor-blindness is guaranteed at all times throughout the study period since the assessor (JDLM) is not involved in the randomization plan or the active interventions.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-64 years, both inclusive
- •Diagnosis: schizophrenia spectrum disorder (F20-F29, ICD-10)
- •Outpatient status
排除标准
- •IQ≤70 as measured by the short form of the Wechsler Adults Intelligence Scale (WAIS) (Wechsler, 1981).
- •History of head injury and/or a neurological condition.
- •Having received a metacognitively oriented therapy within the previous 12 months.
- •Low level of Spanish.
- •Lack of cooperativeness with the assessment and/or "intervention".
研究组 & 干预措施
Metacognitive training (MCT)
干预措施: Metacognitive training (MCT) (Other)
Support group
干预措施: Support group (Other)
结局指标
主要结局
Change in cognitive insight
时间窗: Change in cognitive insight will be evaluated after treatment at 2 months (Month 2) and at 12 months (Month 12). Changes from baseline (Day 0) score to Month 2 (Month 2 - Day 0) and from baseline to Month 12 (Month 12 - Day 0) will be calculated.
The Spanish version of the Beck Cognitive Insight Scale (BCIS), which is a 15-item self-administered scale which evaluates self-reflectiveness (9 items) and self-certainty (6 items). Each item is rated within a Likert scale ranging from 0 ("I disagree") to 4 ("I totally agree") so they can be summed up to create two subtotal scores, namely self-reflectiveness (ranging from 0 to 36, i.e., higher scores, better insight) and self-certainty (ranging from 0 to 24, where higher scores indicate worse insight). A composite index (CI) can also be calculated by subtracting self-certainty from self-reflectiveness so CI higher scores indicate better insight. Internal consistency was found to be acceptable (Cronbach's α=0.60-0.68).
Change in clinical insight
时间窗: Change in clinical insight will be assessed after-treatment at 2 months (Month 2) and at 12 months or follow-up (Month 12). Changes from baseline (Day 0) scores to Month 2 (Month 2-Day0) and from baseline to 12 months (Month 12-Day 0) will be calculated.
The Spanish version of the Schedule for Assessment of Insight (expanded version) (SAI-E) will assess clinical insight. The SAI-E takes the form of a semi-structured interview which enquires about different aspects of insight by means of items ranging from 0 to 3, 4 ,5, or 7. The SAI-E provides scores on three insight dimensions in line with David's model - illness recognition (scores ranging from 0 to 10), symptom relabeling (scores ranging from 0 to 12), treatment compliance (range: 0-6) - and a total insight score (ranging from 0 to 28). Higher scores indicate better insight.
次要结局
- Change in psychotic symptoms severity(Change in psychotic symptoms severity will be assessed at 2 months (Month 2) and at 12 months (Month 12). Changes from baseline (Day 0) scores to 2 months (Month 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.)
- Time to first suicidal event(Data on suicidal behaviour will be collected at 12-month follow-up, which is the trial period.)
- Change in disability(Change in disability will be assessed at 2 months (Month 2) and at 12 months (Month 12). Changes in scores from baseline (Day 0) to 2 months (Month 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.)
- Change in quality of life(Change in quality of life will be determined at 2 months (Month 2) and at 12 months (Month 12). Changes in scores from baseline (Day 0) to 2 months (Month 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.)
- Hospitalizations(Number of hospitalizations and length of stay will be considered over the 1-year follow-up trial period.)
- Change in General Functioning(Change in general functioning will be determined at 2 months (Month 2) and at 12 months (Month 12). Changes in scores from baseline (Day 0) to 2 months (MOnth 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.)
- Change in depressive symptoms severity(Change in depressive symptoms severity will be assessed at 2 months (Month 2) and at 12 months (Month 12). Changes from baseline (Day 0) scores to 2 months (Month 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.)
- Ecological momentary assessment(Memind and eB2 will continuously collect patient's data on behaviour and functioning in real time throughout the trial period from the day of the baseline assessment (Day 0) to the end of the 12-month follow-up period (Month 12).)