Evaluating the Effectiveness of a Digital Platform in the Engagement and Prognosis of Patients in the Early Intervention Programme in Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Adherence to psychosocial treatment.
研究概览
简要总结
This is a randomised, prospective, controlled trial in which one group (experimental group; GE) receives access to the PIPPEP (Intervention Programme for Early Psychosis) platform in addition to the treatment as usual (TAU) in PIPPEP, while the other group (control group; GC) receives only TAU in PIPPEP.
Main objective:
- To assess whether the use of the PIPPEP platform improves psychosocial and pharmacological treatment adherence in mental health programmes.
Secondary objectives:
- To assess the cost-effectiveness of the PIPPEP app.
- Evaluation of the dissemination of the platform.
- To assess the clinical and functional outcomes of patients using the PIPPEP platform in terms of 1) positive symptoms, 2) side effects of antipsychotic medication, 3) perceived social self-stigma, 4) risk assessment, 5) comorbid symptoms and 6) social functioning
The participants are 1) between 18 and 40 years of age, who are being treated in one of the PIPPEP programmes for early intervention in psychosis at Sanitary Parc Sant Joan de Déu and who meet the inclusion criteria "extremely high risk of psychosis", "critical phase or "first psychotic episode" and 2) agree to participate in the study and sign the informed consent form.
详细描述
Background:
Mental disorders are the most common cause of disability in young people, with the disconnect with mental health in adolescents being as high as 50% in some cases. Much research has been conducted on psychotic disorders in recent decades, particularly on their early clinical manifestations. This has led to the establishment of numerous psychosis detection and early intervention programmes around the world to initiate treatment as early as possible.
This situation emphasises the need to change the model of mental health care and focus on the adolescent population in particular with preventive, diagnostic and therapeutic interventions. To improve patient engagement, the importance of a good therapeutic alliance, patient voluntarism, a collaborative approach and clear and continuous communication between patients and professionals was emphasised.
Online and mobile interventions have been shown to be acceptable and effective in improving individuals' self-care practises across a wide range of healthcare settings. They have enabled the implementation of evidence-based interventions to promote healthy behaviours (smoking cessation, physical activity, anxiety, depression...) and reduce barriers to accessing mental health services, and have also been shown to be feasible, acceptable and effective for a wide range of mental health conditions. Ease of use, accessibility and potentially reduced stigmatisation are cited as benefits. They also have the potential to reduce healthcare costs and offer options to aid diagnosis, facilitate real-time assessment and monitoring of symptoms, and provide innovative treatments for a variety of conditions. Adherence rates for these interventions are high, ranging from 60-100% (average 83%). A recent Canadian study conducted with a sample of young people treated in an early intervention team concluded that the use of the internet and various technological devices by young people with a first episode of psychosis is similar to that of young people in the general population of the same age.
Procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adherence to psychosocial treatment.
时间窗: Baseline, 6 months follow-up, 12 months follow-up
Attendance at follow-up appointments with the therapeutic team. Lack of engagement or lack of adherence will be assumed if the patient remains uninterrupted for a period of at least one month despite the need for treatment: 1. does not turn up for scheduled visits and does not report in. 2. cannot be reached by telephone. 3. actively refuses contact with professionals and/or treatment. If one of the above conditions is met, the person's last contact is considered the date of drop-out.
次要结局
- Medication Adherence Scale-8 items(Baseline, 6 months follow-up, 12 months follow-up)
- Global Assessment of Functioning (GAF) scale(Baseline, 6 months follow-up, 12 months follow-up)
- Direct costs use services(Baseline, 6 months follow-up, 12 months follow-up)
- Penetration of the platform(Baseline, 6 months follow-up, 12 months follow-up)
- Indirect costs(Baseline, 6 months follow-up, 12 months follow-up)
- Scale for side effects of medication (UKU)(Baseline, 6 months follow-up, 12 months follow-up)
- Questionnaire on anxiety and depression(Baseline, 6 months follow-up, 12 months follow-up)
- Scale of the Impact of Perceived Symptoms in Schizophrenia(Baseline, 6 months follow-up, 12 months follow-up)
- The Beck Cognitive Insight Scale for Schizophrenia (BCIS)(Baseline, 6 months follow-up, 12 months follow-up)
- Questionnaire on the consumption of toxic substances(Baseline, 6 months follow-up, 12 months follow-up)
- Scale for self-perception of social stigmatisation (SSQ)(Baseline, 6 months follow-up, 12 months follow-up)
- Quality of life. Quality of Life Index (QLI-sp)(Baseline, 6 months follow-up, 12 months follow-up)