Cognitive Remediation and Social Recovery in Early Psychosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Social and Occupational Functional Assessment Scale (SOFAS) (change from baseline)
研究概览
简要总结
This intervention trial explores the feasibility, effectiveness and acceptability of a novel psycho-social intervention for early psychosis based on a combined cognitive remediation training and cognitive behavioural therapy approach focused on social recovery. The impact of the CReSt-R intervention on social cognition as a primary outcome will be explored in addition to secondary outcome measures such as social and occupational functioning ( Detailed further in this registration). Feasibility of the trial design and the acceptability of the CReSt-R intervention to the target group, 16-35 year olds who are within the first 5 years of a diagnosed psychotic illness, are also explored in this trial.
详细描述
This study is being carried out as part of a collaborative doctoral award program entitled Youth Mental Health Research Leadership (YOULEAD, www.nuigalway.ie/youlead) and is funded by the Health Research Board, Ireland.
It is a multi centre, randomised pilot study based at the National University of Ireland,Galway with ethical approval from the Galway University Hospital ethical committee. The principal investigator is Prof. Gary Donohoe and study lead Ms. Emma Frawley, both based at the School of Psychology, National University of Ireland, Galway.
Across psychosis spectrum disorders, social cognition is strongly linked to functional outcomes and therefore considered an important target for intervention.Social Cognition is reported to mediate the effects of neurocognition on functional outcomes.This suggests better functional outcomes may be achieved if both neurocognition and social cognition are targeted in intervention and that neurocognitive training alone does not result in significant social cognitive improvements.
People living with experience of psychotic illness often experience barriers to socialising. For example, experience of positive symptoms in schizophrenia can result in psychological challenges and reduced opportunities to meet and engage with other individuals in a social context. In a 2012 review of social cognitive interventions it was concluded that in order to impact higher-order social cognitive processes, there needs to be ample opportunity for practice of skills both in a clinical setting as well as in the community. A recent meta- analysis and meta-regression study also concluded early intervention in psychosis, where there is a multi-component treatment approach, is associated with better outcomes across a number of variables including global functioning and involvement in school or work. Exploration of the feasibility of the CReSt-R intervention and its ability to integrate into a multi-component treatment approach, is integral to this research study.
The CReSt-R study is novel in its approach, combining the CIRCuiTS cognitive training programme, informed by a metacognitive model, with Social Recovery Therapy, informed by cognitive behavioural theory and assertive outreach.
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
A randomisation procedure for group allocation will be compiled with an independent statistician. A research assistant, blinded to allocation, will complete outcome assessments at the three time points (Prior to the study commencing, 2 weeks post study completion and follow up at 3 months).
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 16 and 35 years' old
- •History of psychosis: within the first five years of a diagnosed psychotic illness (based on time since first contact with mental health services for a psychotic episode)
- •Community-based and clinically stable (in opinion of primary treating team)
- •Ability to give consent
排除标准
- •History of organic impairment
- •History of head injury with loss of consciousness >5-minute duration
- •Drug abuse in the preceding 1 month
结局指标
主要结局
Social and Occupational Functional Assessment Scale (SOFAS) (change from baseline)
时间窗: Post study at 12 weeks and follow up 3-5 months post study
The Social and Occupational Functional Assessment Scale is a global rating of current functioning ranging from 0 to 100.Lower scores represent lower functioning and higher scores represent higher functioning.For example a score of 100 represents superior functioning in a wide range of activities,a score of 50 represents serious impairment in social, occupational or school functioning, a score of 30 represents an inability to function in almost all areas of activity. The minimum value is 0 and the maximum value is 100.
次要结局
- Time Use Survey(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)- Emotion Recognition Task- change being assessed.(Baseline, post study at 12 weeks and 3-5 months post study)
- The Reading the mind in the eyes task- change being assessed.(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- Rey Osterreith Complex Figure (ROCF)(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- The Hinting Task - change being assessed.(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- The Bell Lysaker Emotion Recognition Task (BLERT)- change being assessed.(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- Wechsler abbreviated scale of intelligence- similarities and matrix reasoning subtests(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- Wechsler Memory scale 3rd edition- logical memory and letter number sequencing subtests(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- The Positive and Negative Symptom Scale (PANSS)(Baseline, post study at 12 weeks,follow up 3-5 months post study)
- STROOP(Baseline, post study at 12 weeks,follow up 3-5 months post study)
研究者
Gary Donohoe
Professor
National University of Ireland, Galway, Ireland