Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Executive functions evaluated through Frontal Assessment Battery (FAB)
研究概览
简要总结
The aim of this study is to test the effect of cognitive stimulation (CS), applied individually and at home, on the overall cognitive functioning, emotional state, functionality, and quality of life (QoL) in adults with psychotic disorders. To this end, a randomised controlled clinical trial will be conducted in which selected participants will be randomly assigned to an individual intervention group using CS or a control group. The CS program is adapted from other existing protocol, composed of 32 sessions. Each session will last 45 minutes and will be held twice weekly. There will be four evaluation points (baseline, intra-evaluation - after 8 weeks of intervention, post-evaluation - after 16 weeks of intervention, follow-up - after 8 weeks of the end of intervention).
详细描述
Epidemiological studies indicate that Portugal has one of the highest prevalence rates of mental disorders in Europe. In 2016, one in five Portuguese suffered from a psychiatric illness and the network of Integrated Continuous Care in mental health is small, which is a major constraint to rehabilitation and support responses for people with mental health problems.
It is important to include psychologists and neuropsychologists in multidisciplinary teams, in actions related to mental health promotion and mental illness prevention programs, so that they can provide more comprehensive interventions for other effects of chronic mental health conditions, such as cognitive decline.
There is evidence linking psychotic disorders to impairments in functioning in most cognitive domains, including memory, executive functions, and attention, and that cognitive ageing in some areas may be accelerated in individuals with psychotic disorders. Thus, it is important to focus interventions on cognitive functioning in patients with psychosis, even after acute psychotic symptoms have improved. Executive functions appear to be of particular importance in the context of mental health problems, as they appear to be particularly integral for psychosocial functioning and the completion of instrumental activities of daily living. There is evidence that CS interventions in individual format are associated with greater effectiveness.
Many studies have supported the effectiveness and accessibility of home-based interventions in people with chronic mental illness. Yet, there are few published studies on continuous intervention in people with chronic mental illness and even more limited knowledge of how cognitive stimulation can help chronic mental health patients, including those with psychosis, to function.
One Portuguese study about the effect of an individual CS program in a home setting on cognitive and mood functioning in adults with psychotic disorders was tested, showed encouraging results and presented in detail an intervention protocol. However, it also presents some important limitations (e.g., convenience sample, lack of follow-up evaluation).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults under 65 years.
- •Diagnosed with of schizophrenia spectrum and other psychotic disorders according to the criteria of DSM-5 (APA, 2013), determined by a professional clinician.
- •Willing to participate in all intervention and assessment sessions.
- •Provided informed consent.
- •Native speakers of Portuguese.
排除标准
- •Presentation of a condition requiring immediate intervention (e.g., suicidal thoughts).
- •Severe sensory and physical limitations that prevent participation in the sessions.
- •Severe disconnection with the environment and very limited attentional level.
- •Inability to communicate adequately.
- •Psychoactive substance use.
- •Currently participating in another study.
结局指标
主要结局
Executive functions evaluated through Frontal Assessment Battery (FAB)
时间窗: baseline
The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.
Change in cognitive functioning evaluated through MoCA
时间窗: 8 weeks after end of intervention
Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Cognitive functioning evaluated through Montreal Cognitive Assessment [MoCA]
时间窗: baseline
Cognitive functioning is assessed using the MoCA which is a brief cognitive screening. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
Change in executive functions evaluated through FAB
时间窗: 8 weeks after end of intervention
The FAB is used to assess executive function in several subtests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Scores range from 0 to 18, with higher scores indicating better executive functioning.
次要结局
- Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)(baseline)
- Change in QoL evaluated through SF-36v2(8 weeks after end of intervention)
- Quality of life (QoL) evaluated through MOS Short Form Health Survey 36 Item v2 (SF-36v2)(baseline)
- Change in depressive symptomatology assessed through the CES-D(8 weeks after end of intervention)
- Quality of life (QoL) evaluated through World Health Organization Quality of Life-Bref (WHOQOL-BREF)(baseline)
- Self-maintaining and instrumental activities of daily living evaluated through Lawton Instrumental Activities of Daily Living (IADL) Scale(baseline)
- Change in self-maintaining and instrumental activities of daily living evaluated through Lawton IADL Scale(8 weeks after end of intervention)
- Change in QoL evaluated through WHOQOL-BREF(8 weeks after end of intervention)