NCT04211753招募中不适用
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Self-managing Emotional Crises in People With Borderline Personality Disorder: A Pragmatic Randomized Controlled Trial
Consorci Sanitari del Maresme2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- smartphone addiction
研究概览
简要总结
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotional crisis in a pragmatic randomized controlled trial with 80 patients with borderline personality disorder (40 patients with treatment as usual, TAU) versus 40 patients with TAU plus the mobile App)
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD)
- •Aged 18-60 yeats old
排除标准
- •Comorbidity with mental retardation
- •Comorbidity with psychotic disorder
- •Comorbidity with antisocial personality
- •Comorbidity with autism spectrum disorder
结局指标
主要结局
smartphone addiction
时间窗: 9-month
Severity of smartphone addiction as measured by the Spanish version of the Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity).
Number of psychiatric.emergencies and hospitalizations
时间窗: 9-month
As reported by computerized clinical charts
次要结局
未报告次要终点
研究者
研究点 (2)
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