跳至主要内容
临床试验/NCT06564402
NCT06564402招募中不适用

Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety

Philipps University Marburg1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Social Interaction Anxiety Scale (SIAS)

研究概览

简要总结

Efficacy of an optimized exposure therapy training is investigated in individuals with heightened social anxiety. Participants will undergo a one-session standardized exposure training, followed by either standard or positive mental rehearsal of the exposure experience. The efficacy is measured by symptom improvement according to subjective ratings one week later.

详细描述

Exposure therapy is widely recognized as the gold-standard treatment for anxiety disorders, but its clinically significant response rates remain around 50%. Thus, innovative approaches are needed to improve the efficacy of exposure therapy. One strategy is the mental rehearsal of exposure treatment as a way of supporting the retrieval and consolidation of the exposure memory, which has been demonstrated to be an effective supplement to exposure therapy in a recent study. New conceptualizations also emphasize the role of reward processing and its importance in extinction learning. Several strategies have been proposed to target these reward processes to improve the outcomes of exposure therapy. The present study will examine the use of a positive-focused rehearsal strategy. Participants in the optimized exposure group will engage in an imaginal recounting task focusing on the positive aspects (i.e. emotions, thoughts, behavior) of the exposure. Rehearsal of the positive aspects may increase positive affect, with positive mood thought to be associated with deeper mental rehearsal of stored information. Therefore, the efficacy of using positive mental rehearsal (i.e., imaginal recounting) post-exposure will be investigated, with the use of standard mental rehearsal as an active control group. Participants will be asked to repeat the rehearsal experience at home at two-day intervals. Post-treatment assessment will be conducted one week later. The study will be conducted on healthy participants with an elevated level of social anxiety. The aim of this randomized controlled trial in healthy individuals with increased social anxiety is to investigate whether optimized exposure training (exposure + positive mental rehearsal) is more effective in reducing fear of social interaction compared to an active control group (exposure + mental rehearsal).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elevated score on Social Interactions Anxiety Scale (SIAS) > 26

排除标准

  • Current psychotherapeutic/psychiatric treatment
  • Plans to start psychotherapeutic/psychiatric treatment in upcoming weeks
  • Current suicidal intent
  • Severe cardiovascular, respiratory or neurological diseases

研究组 & 干预措施

Exposure + Positive Mental Rehearsal

Experimental

Mental rehearsal of the positive aspects of exposure experience

干预措施: Positive Mental Rehearsal (Behavioral)

Exposure + Positive Mental Rehearsal

Experimental

Mental rehearsal of the positive aspects of exposure experience

干预措施: Exposure (Behavioral)

Exposure + Mental rehearsal

Active Comparator

Mental rehearsal of the exposure experience

干预措施: Mental Rehearsal (Behavioral)

Exposure + Mental rehearsal

Active Comparator

Mental rehearsal of the exposure experience

干预措施: Exposure (Behavioral)

结局指标

主要结局

Social Interaction Anxiety Scale (SIAS)

时间窗: Change from baseline to post-treatment (i.e., 7-9 days)

20-item questionnaire on a 5-point Likert scale (0 = 'not at all'; 4 = 'very strongly') assessing severity of anxiety experienced in social interactions and situations. Total score range: 0 to 80. Higher scores indicate higher severity of social anxiety.

Liebowitz Social Anxiety Scale (LSAS)

时间窗: Change from baseline to post-treatment (i.e., 7-9 days)

2-items from the Liebowitz Social Anxiety Scale (LSAS) on a 4-point Likert scale (fear: 0 = 'none'; 3 = 'high'; avoidance: 0 = 'never'; 3 = 'usually') assessing fear and avoidance of the in the intervention exposed situations. Higher scores indicating greater level of fear and avoidance.

Communication Anxiety Inventory (CAI) - Trait Version

时间窗: Change from baseline to post-treatment (i.e., 7-9 days)

21-item questionnaire on a 4-point Likert scale (0 = 'almost never'; 3 = 'almost always') assessing an individual's general level of anxiety in communication situations. Total range score: 0 to 84. Higher scores indicate greater level of communication anxiety.

次要结局

  • Communication Anxiety Inventory (CAI) - State Version(Baseline)
  • Post-Event Processing Inventory (PEPI) - Trait Version(Change from baseline to post-treatment (i.e., 7-9 days))
  • Post-Event Processing Inventory (PEPI) - State Version(Post-treatment)
  • Plymouth Sensory Imagery Questionnaire (PSI-Q)(Baseline)
  • Positive and Negative Affect Schedule (PANAS)(Change from baseline to post-treatment (i.e., 7-9 days))
  • Snaith-Hamilton-Pleasure-Scale (SHAPS)(Change from baseline to post-treatment (i.e., 7-9 days))

研究者

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

Christoph Benke

Principal Investigator

Philipps University Marburg

研究点 (1)

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