Internet-delivered Transdiagnostic Intervention for Anxiety and Depression in Romania- A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Penn State Worry Questionnaire (PSWQ)
研究概览
简要总结
Objectives
- To test the effectiveness and acceptability of an augmented internet-supported transdiagnostic intervention in Romania.
- To assess the cost-effectiveness of the Internet version of the transdiagnostic program as compared to a standard treatment/usual care.
详细描述
The effectiveness of a transdiagnostic intervention will be compared with a wait list control group using a randomized control trial (RCT) design in a culture where this has not been tested before. The treatment approach is mainly emotion-focus, teaching participants how to confront and experience uncomfortable emotions, and how more adaptive coping mechanisms could be used. Because internet-delivered interventions represent an effective way to disseminate evidence-based programs, investigators decided to present our intervention online.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be fluent in Romanian
- •be over 18 years
- •have the principal diagnostic of generalized anxiety disorder and/or obsessive-compulsive disorder and/or panic disorder and/or social anxiety disorder and/or major depression disorder and/or dysthymia (or any combination of these diagnostics) on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I)
- •have access to an Internet connected computer
排除标准
- •suicidal ideation
- •ongoing psychological treatment for generalized anxiety disorder and/or obsessive-compulsive disorder and/or panic disorder and/or social anxiety disorder and/or major depression disorder and/or dysthymia
- •other primary disorder that need treatment
- •obstacle to participation (i.e., long travel plans)
- •recent change in psychiatric medication (i.e., during the last 6 weeks)
结局指标
主要结局
Penn State Worry Questionnaire (PSWQ)
时间窗: Absolute values (average score) of PSWQ at 11 weeks (post-intervention)
The PSWQ was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score rages from 16 to 80. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Social Phobia Inventory (SPIN)
时间窗: Absolute values (average score) of SPIN at 11 weeks (post-intervention)
The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score rages from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.
Panic Disorder Severity Scale - Self Report (PDSS-SR)
时间窗: Absolute values (average score) of PDSS-SR at 11 weeks (post-intervention)
The PDSS-SR was designed to measure participant's level of panic. The scale is unidimensional and the total score rages from 0 to 28. Low scores are associated with low levels of panic, while high scores are associated with high levels of panic.
Beck Depression Inventory-II (BDI-II)
时间窗: Absolute values (average score) of BDI-II at 11 weeks (post-intervention)
The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Absolute values (average score) of YBOCS at 11 weeks (post-intervention)
The YBOCS was designed to measure participant's level of obsessions and compulsions (O\&C). The scale total score rages from 0 to 40. Low scores are associated with low levels of O\&C, while high scores are associated with high levels of O\&C.
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)
时间窗: Absolute values (average score) of PCL-5 at 11 weeks (post-intervention)
The PCL-5 was designed to measure participant's level of post-traumatic stress. The scale is unidimensional and the total score rages from 0 to 80. Low scores are associated with low levels of post-traumatic stress, while high scores are associated with high levels of post-traumatic stress.
次要结局
- Almost Perfect Scale-Revised (APS-R)(Absolute values (average score) of APS-R at 11 weeks (post-intervention))
- Beck Anxiety Inventory (BAI)(Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention))
- Anxiety Sensitivity Index (ASI)(Absolute values (average score) of ASI at 11 weeks (post-intervention))
- Emotion Regulation Questionnaire (ERQ)(Absolute values (average score) of ERQ at 11 weeks (post-intervention))