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临床试验/NCT07753538
NCT07753538已完成不适用

Computerized Interpretation Bias Modification Training for Social Anxiety Disorder

University of Wisconsin, Milwaukee1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Brief Fear of Negative Evaluation (BFNE)

研究概览

简要总结

The overall goal of the current study is to develop and evaluate a computerized interpretation bias modification (IBM) training for treating social anxiety disorder (SAD). A key focus is placed on enhancing accessibility and efficacy of IBM for SAD by delivering it through a mobile platform, with three specific aims outlined.

First, the current study aims to examine the efficacy of the IBM training in reducing social anxiety symptoms by comparing the pre-, post-, and follow-up assessments of the IBM group with a control group.

Second, the current study aims to examine the effect of IBM on reducing participants' daily social anxiety symptoms using daily diary methodology.

Third, the investigators also aim to evaluate the feasibility and acceptability of the IBM training. The investigators expect that at least 70% of participants will complete 4 or more of the six training sessions.

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 (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of SAD based on the DIAMOND screening interview
  • Moderate or severe symptoms of SAD as assessed by the Liebowitz Social Anxiety Scale (LSAS score of >= 30)
  • Ages 18-60
  • English as a primary language
  • Possession of a mobile device for access to training and text message for daily diary

排除标准

  • Self-report visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen
  • Self-reported history of a bipolar disorder or psychotic disorder as measured by Diagnostic History Scale
  • Current psychotherapy for SAD

研究组 & 干预措施

Cognitive Bias Modification for Interpretation Bias (CBM-I)

Experimental

CBM-I is designed to modify negative interpretation bias, a core cognitive characteristic of social anxiety disorder. During the training, participants will complete sentence fragments by filling in missing letters, guiding them to interpret ambiguous social scenarios in a benign way. Participants will complete the training three times per week for two weeks.

干预措施: Interpretation Bias Modification Training (Behavioral)

Stress Management Psychoeducation (SMP) Group

Active Comparator

The Stress Management Psychoeducation (SMP) group will also receive a cognitive training intervention involving the completion of sentence fragments by filling in missing letters. However, the training content will focus on stress management strategies, such as relaxation techniques and organizational skills, rather than interpretation bias modification. Participants in the SMP group will also complete the training three times per week for two weeks.

干预措施: Stress Management Psychoeducation (Behavioral)

结局指标

主要结局

Brief Fear of Negative Evaluation (BFNE)

时间窗: Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)

The BFNE is a 12-item questionnaire, evaluating the level of apprehension and distress about expected negative evaluation. The BFNE was used to assess the cognitive symptoms of social anxiety disorder.

Liebowitz Social Anxiety Scale- Self-report Version (LSAS-SR)

时间窗: Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)

The LSAS-SR is a 24-item scale that assesses the severity of social anxiety symptoms across two subscales: the level of anxiety (emotional reaction) and the level of avoidance (behavioral reaction). In the current study, the two subscales will be analyzed separately to evaluate the effects of the intervention on the emotional and behavioral symptoms of social anxiety.

Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

时间窗: Pre-training (baseline); 2-week follow-up (2 weeks after completion of the 2-week intervention)

DIAMOND is a semi-structured diagnostic interview to assess DSM-5 psychiatric disorders and has demonstrated good reliability and validity. For the current study, only the social anxiety disorder module was administered at pre-training and follow-up assessments.

次要结局

  • Treatment Acceptability Questionnaire (TAQ)(2-week follow-up (2 weeks after completion of the 2-week intervention))
  • Word Sentence Association Paradigm (WSAP)(Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention))
  • Daily Diary(2 weeks of training period)
  • Credibility and Expectancy Questionnaire (CEQ)(After the 1st training session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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