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临床试验/NCT02270671
NCT02270671已完成不适用

Attention Bias Modification Training for Socially Anxious Adolescents: A Randomized Control Trial

University College Dublin0 个研究点目标入组 130 人开始时间: 2014年10月最近更新:
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
130
主要终点
Social Phobia and Anxiety at 4-week Post-intervention and 12-week Follow-up

研究概览

简要总结

Attention bias modification training (ABMT) is a computer-based attention training programme designed to modify the way a person's attention is directed to mild threats in the environment. What a person focuses their attention on plays an important role in how safe or unsafe they feel in certain situations. Much research has shown that people with high levels of anxiety tend to focus their attention on negative information in their surroundings. The purpose of ABMT is to set in place attention patterns that do not lead to excessive anxiety. The present study will test whether this treatment is effective in reducing social anxiety in 15-18 year olds in school settings.

The study design consists of two phases. During Phase 1 participants will complete a screening questionnaire in relation to their wellbeing and emotions. This questionnaire will include a measure of the affective, cognitive, and behavioural components of social anxiety in adolescence. Depending on their suitability (i.e. scoring above a cut-off on a standardised measure of social anxiety in Phase 1 of the study), participants may then be invited to take part in a 4-week computer-based attention training programme. The purpose of this phase is to see if ABMT will help young people feel less worried or nervous in social situations by teaching them to focus on their environment differently.

Previous research containing attention training tasks similar to this training programme suggests that attention training can reduce symptoms of social anxiety in adolescents. Individuals who are invited to take part in the training session will be randomly assigned to either the intervention (ABMT) or placebo (inactive) group. Both groups will be asked to complete a 4-week programme involving one computer training session per week (each session takes approximately 15-20 minutes).

Questionnaires will also be given to participants to complete before and after the intervention, along with a 12-week follow up assessment. These will include questionnaires to measure social anxiety, depressive symptoms, and fears in relation to negative evaluation. Each questionnaire will take approximately 40 minutes to complete. Participants will not know whether they have received the intervention or placebo training until after the intervention.

详细描述

Social anxiety disorder (SAD) is among the most prevalent mental disorders in adolescence (Merikangas et al., 2010), 10% of females and 5% of males are diagnosed with SAD in adolescence (Wittchen & Fehm, 2003). SAD is characterised by marked fear or anxiety about social situations in which the individual is exposed to possible scrutiny by others (APA, 2013). SAD is associated with social isolation, poor social skills, low self-esteem, and future comorbid mental disorders (Wittchen et al., 2000). Social anxiety typically develops during adolescence, thus there is a need to detect and treat it early prior to the development of a clinically-diagnosed SAD. Most early interventions for social anxiety have used Cognitive Behavioural Therapy (CBT), which focuses on modifying explicit verbal cognitions (Neil & Christensen, 2009). However, many adolescents do not have access to CBT and many finding it demanding (Otto et al., 2004).

Recently, researchers have developed a novel treatment, Attention Bias Modification (ABM), which aims to modify implicit cognitive biases (MacLeod, 2012). ABM is based on cognitive theories, which propose that individuals with anxiety automatically attend to threat-related information in their environment, and have a bias towards negative information. In support of these theories, research demonstrates a relationship between attention and anxiety (Mathews & MacLeod, 2002), and this relationship appears to be causal (Mogg & Bradley, 1998). Evidence indicates that social anxiety can be reduced through ABM procedures in clinical (Amir et al., 2008) and non-clinical populations (Klump & Amir, 2009). However, little ABM research has been conducted with adolescents (Sportel et al., 2013). Beard et al. (2011) noted that few ABM studies followed the Consolidated Standards of Reporting Trials guidelines, and few have registered as clinical trials (Emmelkamp, 2012).

The Present Study:

This research tests the efficacy of ABM training in reducing social anxiety in adolescents. Given that the age of onset of social anxiety is adolescence, peaking in late teens (Merikangas et al., 2010), this research focuses on 15-18 year olds. Given that no published study has specifically considered the role of gender and its impact on ABM training, this research builds gender into the design, thus the research is in line with best practice (EU Commission, 2011).

Aims & Objectives:

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
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Those who score above the cut-off on the SPAI-C

排除标准

  • Those with a diagnosed mental health disorder
  • Those who are currently attending a mental health professional
  • Those scoring below the cut-off on the SPAI-C
  • Those who decline to participate
  • Those whose parents/guardians do not provide written consent

研究组 & 干预措施

Placebo

Placebo Comparator

The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.

干预措施: Placebo (Other)

Intervention

Experimental

The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.

干预措施: ABMT (Behavioral)

结局指标

主要结局

Social Phobia and Anxiety at 4-week Post-intervention and 12-week Follow-up

时间窗: Post-intervention (week 4), and 12-week follow-up

The Social Phobia and Anxiety Inventory for Children (SPAI-C)(Beidel et al., 1998, 2000) is a 26-item, self-report measure exploring anxiety in social situations. Responses are indicated using a 3-point Likert scale from 0 = never or hardly ever to 2 = most of the time or always with scores ranging from 0-52. Higher scores on the SPAI-C represent higher levels of social anxiety.

Threat Bias Measurement at 4-week Post-intervention and 12-week Follow-up

时间窗: Post-intervention (week 4), and 12-week follow-up

The bias measurement protocol consists of 120 trials (80 angry-neutral and 40 neutral-neutral presentations). Angry face location, probe location, probe type and actor are all fully counterbalanced in presentation. The participant must perform with more than 70% accuracy on the first 10 trials.The threat bias measurement consisted of 120 trials of the dot-probe task, 80 of which contained angry-neutral face pairs and 40 of which contained neutral-neutral face pairs. The threat bias score equal the mean of neutral NT trials minus mean of threat NT trials. A threat bias scores \>0 indicate a bias towards threat, whereas scores \<0 mean that the participant is slower to respond to threatening stimuli than neutral stimuli. Reaction times were measured in milliseconds.

次要结局

  • Fear of Negative Evaluation at 4-week Post-Intervention and 12-week Follow-Up(Post-intervention (week 4), and 12-week follow-up)
  • Depression Symptoms at 4-week Post-intervention and 12-week Follow-up(Post-intervention (week 4), and 12-week follow-up)
  • Anxiety Related Disorders at 4-week Post-intervention and 12-week Follow-up(Post-intervention (week 4), and 12-week follow-up)

研究者

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

Dr. Amanda Fitzgerald

Lecturer

University College Dublin

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