Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Anxiety Severity and Impairment Scale (OASIS)
研究概览
简要总结
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Generalized Anxiety Disorder, Panic Disorder or Social Anxiety Disorder according to the International Neuropsychiatric Interview psychiatric interview (M.I.N.I.)
- •Current treatment for the anxiety disorder with antidepressants with an appropriate dose for at least 8 weeks;
- •Score on OASIS (Overall Anxiety Severity and Impairment Scale)equal or greater than 8
排除标准
- •Other psychiatric disorder that causes more impairment and suffering than generalized anxiety disorder, panic disorder or social anxiety disorder in the clinical evaluation
- •Current Cognitive Behavior Therapy
- •Marked intellectual disability (clinically evident)
- •Suicidal ideation or suicide plan at the time of assessment(M.I.N.I.)
- •Psychotic disorder (M.I.N.I.)
- •Bipolar disorder type I (M.I.N.I.)
- •Abuse / Dependence substances (M.I.N.I.)
研究组 & 干预措施
TAU + ABMT active
Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor
Attention Bias Modification Treatment (ABMT) - active
干预措施: Attentional Bias Modification Treatment (ABMT) - Active (Other)
TAU + AMBT placebo
Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor
Attention Bias Modification Treatment (ABMT) - placebo (sham)
干预措施: Attentional Bias Modification Treatment - Placebo (Other)
结局指标
主要结局
Overall Anxiety Severity and Impairment Scale (OASIS)
时间窗: Endpoint and 3-months follow-up
Disorder non-specific primary outcome: Score change on OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to endpoint and 3-months follow-up
Panic Disorder Severity Scale (PDSS), Generalized Anxiety Disorder 7-item Scale (GAD-7) or Liebowitz Social Anxiety Scale (LSAS)
时间窗: Endpoint and 3-months follow up
Disorder-specific primary outcome: For patients with Panic Disorder - change from baseline to endpoint and 3 months follow-up in the PDSS For patients with Generalized Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the GAD-7 For patients with Social Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the LSAS
次要结局
- Beck Anxiety Inventory (BAI)(Endpoint and 3-months follow-up)
- DSM-5 Cross-Disorder Dimensional Scale [Brazilian version](Endpoint and 3-months follow-up)
- Profile of Mood States (POMS)(Endpoint and 3-months follow-up)
- Beck Depression Inventory (BDI)(Endpoint and 3-months follow-up)
- Clinical Global Impression(CGI)(Endpoint and 3-months follow-up)