Augmenting Interpretative Cognitive Bias Modification Using Memory Reconsolidation Updating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 24 Hours
研究概览
简要总结
The purpose of this study is to determine whether briefly reactivating a fear memory 10 minutes prior to administering a social anxiety treatment will enhance the durability of treatment effects.
详细描述
This study examines whether cognitive bias modification of interpretation (CBM-I) for socially anxious individuals can be augmented with the inclusion of a fear memory reactivation prior to administration of CBM. To date, CBM-I generally involves presenting participants with short vignettes that have ambiguous meaning. The ambiguity is resolved by having the subject complete a word stem at the conclusion of the paragraph, resolving the ambiguity in a positive/negative/neutral fashion. CBM attempts to retrain the tendency for socially phobic individuals to adopt negative interpretations of ambiguous events by repeatedly presenting trials resolving in a positive fashion. An inert control can be administered by having the majority of CBM trials resolve in a neutral fashion, without having the vignette end in either a positive or negative fashion.
Reactivating a fear memory, followed by a short break, purportedly opens a window of several hours during which the fear memory is rendered labile, and so CBM given during this time should show greater durability of effects. However, manipulations given outside of this timeframe will presumably have no increased effects. Individuals exhibiting clinical levels of social anxiety, as measured with the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, will be randomly assigned to one of three conditions: (1) fear reactivation administered 10 minutes prior to CBM, (2) fear reactivation administered 12-36 hours prior to CBM, and (3) fear reactivation administered 12-36 hours prior to an inert form of CBM. A variety of measures measuring anxiety, interpretation bias, and cognitions will be repeatedly assessed across the study, including at pretreatment, post treatment, and at one and two week follow up. Additionally, several potential moderators of treatment outcome will be assessed prior to engaging in treatment. At two week follow up, participants will also be given a speech stressor task to determine its effect on subsequent interpretation bias.
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
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Ages 18-65
- •Score of 30 or above on LSAS
- •Score of 1.4 or greater on ASSIQ
排除标准
- •Receiving any form of anxiety medication or psychotherapy for anxiety during the past 3 months
- •Scoring above a "1" on item 9 of the BDI-II (presence of serious suicidal ideation)
研究组 & 干预措施
Inert CBM With Inert Fear Reactivation
干预措施: Inert CBM With Inert Fear Reactivation (Behavioral)
CBM With Active Fear Reactivation
干预措施: CBM With Active Fear Reactivation (Behavioral)
CBM With Inert Fear Reactivation
干预措施: CBM With Inert Fear Reactivation (Behavioral)
结局指标
主要结局
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 24 Hours
时间窗: pretreatment, 24-hour follow up
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 24 Hours
时间窗: pretreatment, 24-hour follow up
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 1 Week
时间窗: pretreatment, 1-week follow up
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Change From Baseline in Appraisal of Social Concerns Scale (ASC) at 2 Weeks
时间窗: pretreatment, 2-week follow up
The ASC is a 20-item self-report questionnaire that focuses on cognitions present in socially anxious patients. It measures concerns about negative evaluation, observable symptoms, and perceived social helplessness.
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 24 Hours
时间窗: pretreatment, 24-hour follow up
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 1 Week
时间窗: pre-treatment, 1-week follow up
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 2 Weeks
时间窗: pretreatment, 2-week follow up
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) at 2 Weeks
时间窗: pre-treatment, 2-week follow up
The LSAS is a commonly used measure of social anxiety that measures fear as well as avoidance behaviors concerning social interactions. The study will use a computerized, self-report version of the LSAS, which has demonstrated little deviation from clinician-administered LSAS scores.
Change From Baseline in Brief Fear of Negative Evaluation Scale (BFNE) at 1 Week
时间窗: pretreatment, 1-week follow up
The 12-item, self-report Brief Fear of Negative Evaluation Scale measures fear of negative evaluation by others, which is a distinguishing characteristic of social anxiety. The scale is derived from the original 30-item Fear of Negative Evaluation measurement.
次要结局
- Word Sentence Association Paradigm (WSAP)(pretreatment (assessed twice: before & after fear retrieval), post-treatment (within 30 minutes following CBM administration), 1-week follow up, 2-week follow up (assessed twice at 2-week follow up: before and after a speech task stressor))
- Ambiguous Social Scenarios Interpretation Questionnaire (ASSIQ)(pretreatment, post-treatment (within 30 minutes following CBM administration), 1-week follow up, 2-week follow up (assessed twice at 2-week follow up: before and after a speech task stressor))
- Self-Beliefs Related To Social Anxiety Scale (SBSA)(pretreatment)
- Interpretation of Positive Events Scale (IPES)(pretreatment)
- Beck Depression Inventory-II (BDI-II)(pretreatment)
- Brief State-Trait Anxiety Inventory- State (BSTAI)(pretreatment (assessed 3x: before & after fear retrieval, & immediately before CBM), post treatment (within 30 minutes following CBM administration), 1-week follow up, 2-week follow up (assessed 2x at two-week follow up: before & after speech stressor))
- Perception of Speech Performance Measure (PSP)(2-week follow up (after speech stressor task))
- Dot Probe Task(pretreatment)
研究者
Michael J. Telch
Principal Investigator
University of Texas at Austin