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临床试验/NCT03101553
NCT03101553已完成不适用

Computerized Treatment for Social Anxiety

Florida State University2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Social Phobia Inventory (SPIN; Davidson, 1995)

研究概览

简要总结

The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) The effects of condition will be maintained at the 3-month follow-up assessment.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current diagnosis of Social Anxiety Disorder according to DSM-5 criteria
  • SPIN score greater than or equal to 30
  • Must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation))

排除标准

  • Concurrent psychotherapy or treatment for social anxiety disorder
  • Clinically significant suicidality
  • Current Alcohol Use Disorder of "Severe" severity or higher
  • Current Non-alcohol Substance Use Disorder of "Moderate" severity or higher
  • Recent changes (less than four weeks) in psychiatric medication
  • History of psychotic symptoms
  • May not have participated in a similar computerized treatment program

结局指标

主要结局

Social Phobia Inventory (SPIN; Davidson, 1995)

时间窗: change from baseline at one-week post treatment and 3-months post-treatment

Measures past-week social anxiety symptom severity

次要结局

  • Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)(change from baseline at one-week post treatment and 3-months post-treatment)
  • Beck Anxiety Inventory (BAI; Steer & Beck, 1997)(change from baseline at one-week post treatment and 3-months post-treatment)
  • Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)(change from baseline at one-week post treatment and 3-months post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesse Cougle

Associate Professor

Florida State University

研究点 (2)

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