The Effect of a Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Penn State Worry Questionnaire (PSWQ)
研究概览
简要总结
The project's aim is to investigate the effect of a transdiagnostic, self-guided, internet-based cognitive behavioral therapy program in waitlist patients with anxiety disorders.
详细描述
Patients who fulfill the inclusion criteria and are interested in psychotherapy are offered participation in the study to bridge the waiting time for face-to-face psychotherapy. After obtaining informed consent, a pre-treatment assessment is conducted. Then, participants are provided access to velibra, an internet-based cognitive behavioral therapy program which they can work through at their own pace. While velibra is a self-guided program, participants are supported by study personnel during four assessments at four time points: pre-treatment, mid-treatment (after the first three velibra modules), post-treatment and at the one-month follow-up. The investigators expect improvements on the primary as well as the secondary outcomes. Furthermore, the investigators are interested in studying the acceptability of velibra and whether positive changes already become observable after the first three modules, i.e., at the mid-treatment assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 panic disorder with or without agoraphobia, social anxiety disorder, or generalized anxiety disorder
- •Knowledge of German that is sufficient for engaging with the treatment and responding to the questionnaires
- •Written informed consent
- •Internet access
排除标准
- •Diagnoses of severe mental comorbidities (e.g., schizophrenia, severe major depression, borderline personality disorder)
- •Acute suicidality
- •Started or changed anxiolytic pharmacotherapy recently (currently or in the past four weeks)
结局指标
主要结局
Penn State Worry Questionnaire (PSWQ)
时间窗: 1-month follow-up
The Penn State Worry Questionnaire (PSWQ) is a self-report questionnaire used to measure the symptom severity of generalized anxiety disorder It is given to study participants diagnosed with generalized anxiety disorder. Total score values range from 16 to 80, with higher scores indicating a worse outcome.
Liebowitz Social Anxiety Scale (LSAS)
时间窗: 1-month follow-up
The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire used to measure the symptom severity of social anxiety disorder. It is given to study participants diagnosed with social anxiety disorder. Total score values range from 0 to 72, with higher scores indicating a worse outcome.
Panic and Agoraphobia Scale (PAS)
时间窗: 1-month follow-up
The Panic and Agoraphobia Scale (PAS) is a self-report questionnaire used to measure the symptom severity of panic disorder with or without agoraphobia. It is given to study participants diagnosed with panic disorder with or without agoraphobia. Total score values range from 0 to 52, with higher scores indicating a worse outcome.
次要结局
- Beck Anxiety Inventory (BAI)(1-month follow-up)
- Internal, Powerful Others, and Chance Questionnaire (IPC)(1-month follow-up)
- Beck Depression Inventory-II (BDI-II)(1-month follow-up)
- ICD-10-Symptom-Rating (ISR)(1-month follow-up)
- Short-Form Health Survey (SF-12)(1-month follow-up)
- Anxiety Sensitivity Index (ASI)(1-month follow-up)
- General Self--Efficacy Scale (GES)(1-month follow-up)
研究者
Lena Pyrkosch
Psychologist
Charite University, Berlin, Germany