跳至主要内容
临床试验/NCT06409247
NCT06409247进行中(未招募)不适用

Testing the Role of Attentional and Audio Vocal Mechanisms in a New Internet- Based Intervention for Social Anxiety: iExposure

Palo Alto University1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
390
试验地点
1
主要终点
Personal Report of Communication Apprehension (PRCA)

研究概览

简要总结

Social anxiety (SA) is a highly prevalent mental health concern, thought to disproportionately affect youth with recent international estimates of more than 30% of individuals reporting clinically elevated symptoms. Despite the prevalence of SA, as few as one in five individuals receive care, due to limited access to evidence-based treatments. Additionally there has been a notable increase in social anxiety since the start of the COVID-19 pandemic. This proposal will use iExposure to develop a personalized mechanism-focused approach to optimizing treatment response for individuals with social anxiety by testing standard iExposure against two augmentations that incorporate distinct attention mechanisms (attention guidance and attention control).

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

入选标准

  • Age 18 or older
  • Fluent in English
  • Leibowitz Social Anxiety Scale > 47 and endorses both social anxiety items on the Web Screening Questionnaire for Common Mental Disorders

排除标准

  • Currently receiving CBT for Social Anxiety Disorder
  • Significant visual impairment precluding engagement in the simulated teleconferencing interactions
  • Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
  • Current alcohol or substance use disorder
  • Current or past bipolar disorder or psychosis

研究组 & 干预措施

Standard iExposure

Active Comparator

iExposure. Participants will complete four intervention sessions within two weeks. The intervention will use an entirely self-guided protocol delivered via Qualtrics and Gorilla Experiment Builder:

  1. During the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
  2. Participants will then complete 10 simulated teleconferencing interaction trials with different topics, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members to respond to a question (described in further detail in the Materials section, below).
  3. Participants will complete the Subjective Units of Distress Scale before and after each speech trial.
  4. Sessions 2-4 involve the same protocol and the four intervention sessions are completed within two weeks.

干预措施: iExposure (Behavioral)

iExposure + Attention Guidance Augmentation

Experimental

Attention Guidance Augmentation. The attention guidance condition consists of two unique components in addition to the standard iExposure intervention: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given a target audience member to focus their gaze on during each impromptu response. They will be told that they should look at and focus on the target audience member for the whole response. In each progressive session the number of trials where the participant is directed to focus on an uninterested audience member will increase.

干预措施: iExposure plus attention guidance (Behavioral)

iExposure + Attention Control Augmentation

Experimental

The attention control condition consists of two unique components in addition to the standard iExposure intervention (1) the intervention rationale will include information about the importance of developing attention control; (2) participants will be given a central region of the screen (non-audience member) to focus on. They will be told that they should look at and focus on the central region for the whole response.

干预措施: iExposure plus attention control (Behavioral)

结局指标

主要结局

Personal Report of Communication Apprehension (PRCA)

时间窗: 0 days

The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.

Personal Report of Communication Apprehension

时间窗: 45 days

The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.

Liebowitz Social Anxiety Scale Self Report Version

时间窗: 45 days

The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.

Liebowitz Social Anxiety Scale Self Report Version

时间窗: 0 days

The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.

Liebowitz Social Anxiety Scale Self Report Version

时间窗: 15 days

The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.

Personal Report of Communication Apprehension

时间窗: 15 days

The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.

次要结局

  • Center for Epidemiologic Studies Depression Scale - Revised(45 days)
  • Center for Epidemiologic Studies Depression Scale - Revised(0 days)
  • Center for Epidemiologic Studies Depression Scale - Revised(15 days)

研究者

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

Mikael Rubin

Assistant Professor

Palo Alto University

研究点 (1)

Loading locations...

相似试验

iExposure Intervention for Social Anxiety | 临床试验