Guided and Unguided CBT for Social Anxiety Disorder and/or Panic Disorder Via the Internet and a Smartphone Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- The Generalised Anxiety Disorder 7-item (GAD-7)
研究概览
简要总结
BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a tailored smartphone application. The effect of added therapist support will also be studied.
METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to one of three treatment arms: (1) smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without therapist support; or (3) an active waiting list control group with delayed treatment. After the 10 week treatment period, the control group (3) will receive the same treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment and two follow-up assessments (12 and 24 months).
HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be superior to the unguided form in reducing anxiety levels, and that both delivery modes will be superior to an active waiting-list control group.
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
- •Satisfy DSM-IV-TR criteria for panic disorder and/or social anxiety disorder as assessed by the SCID.
- •Daily access to the Internet via computer and smartphone
- •Residing in Sweden and speaking sufficient Swedish to communicate with the research team
排除标准
- •Parallel psychological treatment
- •Non-stable dosage of psychoactive medication during last 3 months
- •Participants deemed to suffer from suicidal tendencies or another condition requiring specialized treatment
结局指标
主要结局
The Generalised Anxiety Disorder 7-item (GAD-7)
时间窗: Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.
The Generalised Anxiety Disorder 7-item (GAD-7). The 7 items of the scales are rated 0-3 ("Not at all" to "Nearly every day") based on their occurrence within the last 2 weeks. Good internal consistency and factor structure has been reported.
次要结局
- Quality of Life Inventory (QOLI)(Change from baseline at: [1] 0-1 week after the treatment period; follow-ups at [2] month 12 and [3] month 36 after the treatment period.)
- 9-item Patient Health Questionnaire (PHQ-9)(Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)
- Self-rated Liebowitz Social Anxiety Scale (LSAS-SR)(Change from baseline at: [1] 0-1 week after the treatment period; follow-ups at [2] month 12 and [3] month 36 after the treatment period.)
- Self-rated Panic Disorder Severity Scale (PDSS-SR)(Change from baseline at: [1] 0-1 week after the treatment period; follow-ups at [2] month 12 and [3] month 36 after the treatment period.)
研究者
Per Carlbring
Professor
Stockholm University