Smartphone App-based Integrated Cognitive Control Training for Cognitive Dysfunction in Anxiety Disorders: a Multi-site Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Measure of anxiety severity
研究概览
简要总结
Anxiety disorders (ADs; disorders characterized by debilitating anxiety) may be a ‘silent epidemic’ affecting approximately 3-4% of India’s population, and among the top worldwide causes of disability. Cognitive deficits (e.g., executive functions and memory) may contribute to socio-occupational dysfunction, and even longitudinally predict development of anxiety symptoms. Cognitive training may enhance cognitive and clinical outcomes through targeting underlying neural mechanisms. Attempts in ADs are few, and show limited improvements in untrained domains.
Research gap:
- No published research on cognitive training in ADs in India. Existing international studies are sparse, mostly analog sample studies.
- Existing studies of cognitive training demonstrate limited transfer of effects, possibly due to methodological issues.
- In India, existing cognitive training programs for other disorders cannot be used in ADs because - a. developed for severe deficits (e.g., brain injuries), not suited for ADs; b. lack of flexibility for individual differences in ability levels; c. not suited for self-administration, i.e, require trained neuropsychologist to deliver and/or carer supervision
The investigators have previously piloted a smartphone app-based Integrated Cognitive Control Training (ICCT) intervention, demonstrating improvements on cognitive control, and transfer to other untrained domains. Since ICCT focusses on the transdiagnostic component of cognitive control, with dose, duration and methods informed by evidence-based guidelines of CT, it is well-suited for extension to ADs.
The current proposal aims to compare ICCT (n=50) against Treatment-as-usual (TAU; n=50) in a randomized control design with multimodal assessments at baseline, mid-, post-intervention, and follow-up. The 8-week ICCT will comprise cognitive stimulation tasks, metacognitive strategy monitoring and generalization exercises, using a smartphone app, Cogtrain, to be modified and upgraded in this study. It is hypothesized that ICCT, compared to TAU, will lead to significant gains on cognitive control, as well as other cognitive domains (processing speed, planning, memory, visuospatial functions, metacognitive self-regulation), symptom severity measures, socio-occupational functioning, cognitive task-based functional connectivity, and hemodynamic alterations after 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Current DSM 5 diagnosis of anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, or phobic anxiety disorders), Stable on medication or off medication (no changes to medication during the course of the study or in preceding 3 months) Aged
- •50 years, Minimum 7th std education with working knowledge in English Amenable for neurocognitive assessments and training Access to smartphone.
排除标准
- •History of severe mental disorders (bipolar or psychotic disorders), History of central nervous system conditions (traumatic brain injury tumours, epilepsy, stroke, degenerative disorders), Comorbid substance/behaviour addictions (alcohol and other drugs except nicotine, gambling/gaming/technology addiction) History of developmental disorders including intellectual disability Exposure to more than 3 sessions of structured psychotherapy in preceding 3 months, Exposure to brain stimulation in the preceding 3 months.
结局指标
主要结局
Measure of anxiety severity
时间窗: Pre: Week 1, Mid: Week 4-6, Post: Week 10-12 and Follow-up: Week 20-24(if feasible)
次要结局
- Socio-occupational functioning(Cognitive functions)
研究者
Dr Himani Kashyap
National Institute of Mental Health and Neuro Sciences (NIMHANS)