A Clinical Trial of a Gamified Attention Bias Modification Training in Anxious Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Clinical Global Impression of Improvement Scale
研究概览
简要总结
Background: Attention bias modification training (ABMT) and cognitive behavioral therapy (CBT) likely target different aspects of aberrant threat responses in anxiety disorders and may be combined to maximize therapeutic benefit. However, studies investigating the effect of ABMT in the context of CBT have yielded mixed results.
Objective: The primary goal of this project is to utilize an enhanced ABMT to target attentional bias towards threat, in addition to classic CBT for anxiety disorders in youth, to determine the efficacy of ABMT in the context of CBT.
Study Population: 121 youth (8-17 years old) with a primary anxiety disorder diagnosis
Methods: In this sub-study,
- Participants will receive open CBT treatment.
- Open CBT treatment will be augmented with computer-based attention retraining, delivered in a randomized-controlled design, with random assignment to either active or placebo attention-training regimens.
- This enhanced ABMT integrates a modified dot-probe task used in previous studies, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus, with a visual search, where the targets are always presented distally of threatening distractors.
- These two training elements (modified dot-probe and visual search) will be embedded in an engaging game to foster motivation and adherence.
Outcome: Symptom improvement will be compared between the two study arms.
详细描述
Background: Attention bias modification training (ABMT) and cognitive behavioral therapy (CBT) likely target different aspects of aberrant threat responses in anxiety disorders and may be combined to maximize therapeutic benefit. However, studies investigating the effect of ABMT in the context of CBT have yielded mixed results.
Objective: The primary goal of this project is to utilize an enhanced ABMT to target attentional bias towards threat, in addition to classic CBT for anxiety disorders in youth, to determine the efficacy of ABMT in the context of CBT.
Study Population: 121 youth (8-17 years old) with a primary anxiety disorder diagnosis who are originally consented on 01-M-0192 will be recruited and randomized to each arm in the sub-study
Methods: In this sub-study,
- Participants will receive open CBT treatment.
- Open CBT treatment will be augmented with computer-based attention retraining, delivered in a randomized-controlled design, with random assignment to either active or placebo attention-training regimens.
- This enhanced ABMT integrates a modified dot-probe task used in previous studies, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus, with a visual search, where the targets are always presented distally of threatening distractors.
- These two training elements (modified dot-probe and visual search) will be embedded in an engaging game to foster motivation and adherence.
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, Investigator)
盲法说明
The active and control treatment arms differ in the spatial arrangements of figures on a computer screen. Because these figures are presented for very brief periods of time, subjects cannot easily decipher differences in the arrangements across the active and control treatments. All study team members who work with patients remain blind to the treatment conditions as well.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALL JUVENILE SUBJECTS WITH AN ANXIETY DISORDER:
- •Diagnosis: Current Diagnosis of Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles))
- •Symptom Severity: Clinically significant, ongoing anxiety symptoms
- •Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety
- •Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17- year- old but do not turn 18).
- •Consent: can give consent/assent (Parents will provide consent; minors will provide assent)
- •IQ: all subjects will have intelligence quotient (IQ) > 70 (Assessment relies on WASI)
- •Language: all subjects will speak English
排除标准
- •Any serious medical condition or condition that interferes with participation
- •Pregnancy
- •Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy.
- •Current diagnoses Tourette's Disorder, obsessive compulsive disorder (OCD), post-traumatic distress disorder, conduct disorder
- •Past or current history of mania, psychosis, or severe pervasive developmental disorder
- •Recent use of an selective serotonin reuptake inhibitor (SSRI); all subjects must have been free of any SSRI-use for at least one month (fluoxetine six months) and must not have been treated with an SSRI for their current depressive episode.
- •National Institute of Mental Health (NIMH) employees and staff and their immediate family members will be excluded from the study per NIMH policy
研究组 & 干预措施
Active Intervention
Children and adolescent participants with anxiety disorder receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete the Active Attention Bias Modification Training (ABMT), computer-based attention bias modification training aimed at re-training attentional biases before a CBT session: Part 1. modified dot-probe task, where a target is always presented at the previous location of the neutral and not the simultaneously presented threatening stimulus. Part 2. visual search, where the targets are always presented distally of threatening distractors.
干预措施: Active Attention Bias Modification Training (Behavioral)
Control Intervention
Children and adolescent participants with anxiety disorder receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete the control intervention before a CBT session: Part 1. dot-probe task, where a target is equally randomly presented at the previous location of the neutral or the simultaneously presented threatening stimulus. Part 2. visual search, where the targets are equally randomly presented distal of neutral and threatening distractors.
干预措施: Placebo Attention Bias Modification Training (Behavioral)
结局指标
主要结局
Clinical Global Impression of Improvement Scale
时间窗: Week 8
The Clinical Global Impression of Improvement (CGI-I) scale is a measure of global symptom improvement rated by clinicians. Scores range from 1-7, with lower scores reflecting greater levels of improvement. This scale provides an ordinal outcome, as participants with CGI-I ratings less than or equal to 3 at week 8 are considered "responders" and participants with scores \>3 at week 8 are considered "non-responders".
Pediatric Anxiety Rating Scale
时间窗: Weeks 3, 8, and 12
The Pediatric Anxiety Rating Scale (PARS) measures anxiety symptoms and related functional impairment in youth as continuous outcome. It comprises a 50- item checklist asking for seven dimensions of global severity/ impairment: Each item is rated on a 0- 5 scale by a clinician based on parent- and child-report. The sum score is calculated based on 5 of the 7 sub-scales and ranges from 0 to 25 with higher scores reflecting greater levels of anxiety. PARS score was measured at different time points during the study.
次要结局
- Children's Global Assessment Scale(Weeks 3, 8, and 12)
- Screen for Child Anxiety Related Disorders(Weeks 3, 8, and 12)
- State-Trait Anxiety Inventory for Children(Weeks 3, 8, and 12)
- Self-Efficacy Questionnaire(Pre-Treatment Screening, Weeks 3, and 12)