e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 12
- 主要终点
- Prognosis of patients.
研究概览
简要总结
Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.
Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.
Hypotheses:
- Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving disease evolution.
- BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
- Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
- The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.
详细描述
Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.
Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.
Hypotheses:
- Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving the disease evolution.
- BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
- Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
- The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.
Primary Objective:
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)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have suffered a first psychotic episode (diagnosis IV-TR) in the last five years,
- •age between 18 and 45 years,
- •patients who have given written informed consent to participate.
排除标准
- •patients with a comorbid disorder that interferes with their ability to communicate,
- •patients who received psychoeducation previous to inclusion in study.
结局指标
主要结局
Prognosis of patients.
时间窗: 6 months
To assess the prognosis of patients by registering the number of relapses and the number of psychiatric hospital admissions.
次要结局
- Score on clinical scales assessing functionality.(6 months)
- Score of participating psychotherapists on a specific test after online training.(6 months)
- Biological Parameters: blood levels of BDNF.(6 months)
- Biological Parameters: levels oxidative stress indicators in blood.(6 months)
研究者
Ana María González-Pinto
Ph.D. in Medicine, Psychiatrist, Lecturer at University of the Basque Country, Chief of Psychiatry Department at Araba University Hospital
Basque Health Service