A Case Series Examination of Metacognitive Reflection and Insight Therapy (MERIT) on Individual Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Negative symptoms
研究概览
简要总结
Negative symptoms (e.g. diminished pleasure and motivation) are common in people with a diagnosis of schizophrenia. Little is known about the psychological mechanisms involved in negative symptom development and maintenance and there is limited evidence for current treatment options. Some research suggests that difficulties with metacognition; the capacity to develop and use complex ideas about oneself and others, may predict experiences of negative symptoms. This study will investigate whether Metacognitive Reflection and Insight Therapy (MERIT) improves metacognition in people experiencing negative symptoms, and if metacognitive changes lead to observable differences in behavioural manifestations of negative symptoms (e.g. low activity levels).
Data will be collected via standardised assessments of metacognition and negative symptoms. Activity levels will be measured with actigraphy, which has been shown to capture differential activity patterns for individuals who experience negative symptoms compared to control groups. An assessment will also be made of whether improvements in specific aspects of metacognition (e.g. self-reflectivity) relate to changes in individual negative symptoms, such as motivation levels, and other markers of personal change, including personal and social performance, insight, and beliefs about recovery.
Additionally, factors that may have impacted on the study results, such as therapist adherence to the treatment, will be reported. Eligible patients with capacity to consent will be recruited from the inpatient rehabilitation psychology services in National Health Service (NHS) Greater Glasgow and Clyde. They will be aged 18 or over, have a schizophrenia spectrum disorder diagnosis, and experience current negative symptoms. The target sample size is up to 8 patients. Participants will be measured at baseline and will receive up to 26 sessions of the MERIT treatment approach. Any therapeutic change will be observed via changes from assessments at baseline to the assessments in the initial, middle and last therapy sessions, and also metacognitive assessments at two other randomly selected time-points during therapy.
详细描述
Hypotheses around metacognitive changes:
It is hypothesised that metacognition scores on the Metacognition Assessment Scale - Abbreviated (MAS-A) will increase with the implementation of Metacognitive Reflection and Insight Therapy (MERIT) over the course of treatment. It is also estimated that this will be related to changes in therapist-rated metacognition, and measures of participant insight (using the Beck Cognitive Insight Scale; BCIS). It is also anticipated that changes in participants' metacognition will also be related to whether therapist metacognition appears to match the level of participant metacognition demonstrated within session.
Hypotheses around impact on negative symptoms and secondary outcomes:
It is estimated that fewer manifestations of negative symptoms (e.g. low-activity levels) will be observed over the course of therapy compared to the baseline period, and that this will also be related to changes in the Clinical Assessment Interview of Negative Symptoms (CAINS), the Self-experience of Negative Symptoms scale (SNS), the Personal and Social Performance Scale (PSP), the Personal Questionnaire: Rapid Scaling Technique (PQRST) and the Questionnaire about the Process of Recovery (QPR).
Design rationale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Receiving inpatient rehabilitation services in NHS GG&C
- •Schizophrenia spectrum diagnosis, defined by diagnostic codes F20-29 from the International Classification of Diseases - 10th Edition (ICD-10; World Health Organization, 1992)
- •Sufficient capacity to provide informed consent, as determined by treating clinician
- •Score 4 or above from a possible total score of 8 in any subdomain of negative symptoms (alogia, avolition,anhedonia, social withdrawal or diminished emotional range) on the Self-evaluation of Negative Symptoms measure (SNS)
- •Moderate to severe scores on either the motivation and pleasure scale or the expression scale of the Clinical Assessment Interview for Negative Symptoms (CAINS; resulting in a required score of 18 or above for items 1-9 and a score of 8 or above for items 10-13)
排除标准
- •None, assuming all Inclusion Criteria are met
结局指标
主要结局
Change in Negative symptoms
时间窗: Between baseline and week 1/week 13/week 26 of intervention
Activity levels as measured by actigraphy device
次要结局
- Clinical Assessment Interview for Negative Symptoms(baseline and week 1, week 13 and week 26 of intervention)
- Self-Evaluation of Negative Symptoms(baseline and week 1, week 13 and week 26 of intervention)
- Metacognition Assessment Scale - Adapted(baseline and week 1, week 13 and week 26 of intervention, plus two randomly selected timepoints between weeks 1-13 of intervention and weeks 14-26 of intervention.)
- Metacognition Assessment Scale - Adapted, therapist rated(measured on a weekly basis during intervention period (up to 26 weeks))
- Beck Cognitive Insight Scale(baseline and week 1, week 13 and week 26 of intervention)
- Personal and Social Performance scale(baseline and week 1, week 13 and week 26 of intervention)
- Personal Questionnaire Rapid Scaling Technique(measured on a weekly basis during intervention period (up to 26 weeks))
- Time Use Survey(baseline and week 1, week 13 and week 26 of intervention)
- Questionnaire about the Process of Recovery(baseline and week 1, week 13 and week 26 of intervention)