Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Gaia AG
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Borderline Symptoms List 23 (BSL-23)
研究概览
简要总结
This randomized controlled trial (RCT) with 470 patients diagnosed with Borderline Personality Disorder (BPD) aims to investigate the effectiveness of the unguided digital therapeutic alivis for patients with BPD as defined in DSM-5. Inclusion criteria are: male, female or non-binary, age 18-65 years, diagnosis of BPD (confirmed by SCID-5-PD), borderline severity score (cut-off) of ≥ 1.07 on the Borderline Symptoms List 23 (BSL-23), stable treatment (psychotherapy, medication, no treatment, …) for at least 30 days at the time of inclusion, consent to emergency plan for suicidal crises, consent to participation, and sufficient German language skills. Exclusion criteria are: Plans to change in treatment (psychotherapy, medication, …) in the upcoming 6 months after inclusion, comorbid diagnosis of substance use disorder or lifetime diagnosis of psychotic disorder, physical condition that can cause severe psychiatric symptoms, acute decompensation of mental health, BMI <15, and prior use of the digital intervention priovi.
Patients will be randomized and allocated to either an intervention group, in which they will receive access to alivis in addition to treatment as usual (TAU; n=235), or to a control group, in which they will receive access to TAU (n=235).
The primary endpoint will be BPD symptoms with three months post-allocation (T1) being the primary timepoint for assessment of effectiveness. Six (T2) and twelve (T3) months post-allocation will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, anxiety symptoms, costs caused due to the patient's BPD, social functioning, health-related quality of life, and patient activation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of BPD
- •Borderline severity score (cut-off) of ≥ 1.07 on the BSL-23
- •Stable treatment (e.g., psychotherapy, medication, no treatment) for at least 30 days at the time of inclusion
- •Consent to emergency plan for suicidal crises
- •Consent to participation
- •Sufficient knowledge of the German language
排除标准
- •Plans to change treatment (e.g., psychotherapy, medication) in the upcoming 6 months after inclusion
- •Comorbid diagnosis of substance use disorder
- •Lifetime diagnosis of psychotic disorder like schizophrenia or schizoaffective disorder (except non-transitory paranoid ideas that can be concomitant with BPD and in which the ability to test reality is mostly preserved)
- •Diagnosis of a physical condition that can cause serious psychiatric symptoms
- •Acute decompensation of mental health symptoms, e.g. acute manic state or acute suicidality
- •BMI < 15
- •Current psychiatric day-care or inpatient treatment
- •Prior use of the digital intervention priovi
研究组 & 干预措施
alivis + TAU
Participants in the intervention group will receive access to alivis in addition to treatment as usual (TAU) for 12 months.
干预措施: alivis (Behavioral)
TAU
Participants in the control group will receive access to treatment as usual (TAU) only. They will receive access to alivis after their last study visit (T3; 12 months after randomization).
结局指标
主要结局
Borderline Symptoms List 23 (BSL-23)
时间窗: T1 (3 months after randomization)
The BSL-23 is a 23-item PROM with good psychometric properties that was validated and tested for reliability in a representative German sample (test-retest reliability r = .82, p \< 0.0001; α = 0.94-0.97; high correlation of total score with general psychological burden and depression) to assess the typical symptomatology and severity of BPD. It refers to the last week and has a range from 0 = "not at all" to 4 = "very strong". Its single factor structure was optimized to reflect levels and changes in severity of BPD-symptomatology based on a mean score. Higher mean scores indicate greater symptom severity and thus a worse outcome, whereas lower scores indicate fewer BPD-related symptoms and a better outcome.
次要结局
- Patient Health Questionnaire 9 (PHQ-9)(T1 (3 months after randomization))
- Generalized Anxiety Disorder Assessment 7 (GAD-7)(T1 (3 months after randomization))
- Work and Social Adjustment Scale (WSAS)(T1 (3 months after randomization))
- Patient Activation Measure (PAM-13)(T1 (3 months after randomization))
- Assessment of Quality of Life 8 Dimensions (AQoL-8D)(T1 (3 months after randomization))
- Costs Caused Due to the Patients BPD(T1 (3 months after randomization))