The effect of multi-domain intervention (YoCogDiPP) on cognitive impairment, heart rate variability, cortisol, inflammatory markers and depression scores in patients with depression: randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement in cognitive, autonomic, inflammatory markers with reduction in depression scores.
研究概览
简要总结
Rationale/ gaps in existing knowledge: Despite the advances in management of depression the strategies have failed in reaching out to the target population and thus failed to reduce the disease prevalence. This is because apart from being a mood disorder depression has a significant cognitive, autonomic, stress and inflammatory components to it. Cognitive impairment links to reduced prefrontal cortex activation. Patients experience autonomic dysfunction with decreased vagal tone, elevated cortisol (stress) and increased inflammatory markers like IL-6, CRP, and TNF-alpha. Novelty: This is first study of its kind use multi-domain intervention that include Yoga nidra, Cognitive training and lifestyle modifications (Diet and Physical activity) along with standard of care (Pharmacological treatment) i.e. YoCogDiPP to holistically target cognitive, autonomic, stress and inflammatory components of depression Objectives: To compare cognitive impairment, heart rate variability, cortisol levels, inflammatory markers, and depression scores in patients with depression before and after 4, 8, and 12 weeks of multidomain intervention, and to compare these measures between multidomain intervention and only pharmacological treatment. Methods: This study will follow a 12-week randomized controlled trial design (details in methodology) Expected outcome: The study results will aid in understanding depression’s pathophysiology, focusing on stress, inflammation, prefrontal cortical involvement, and cognitive impairment. Additionally, it will explore the impact of multidomain intervention. If successful, the study could transform into a digital app, enhancing accessibility for patients at home, addressing compliance issues. This intervention could then reach a broader population, reducing depression-related morbidity, mortality, and financial losses in society.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-55 years both genders, Diagnosis according to ICD 10 (F32.xx and F33.xx except F32.3 and F33.3) by psychiatrist, HDRS score equal to or more than 8, ongoing treatment for atleast 4 weeks or more, normal or corrected to normal vision (6/6 according to Snellen chart), normal color vision assessed by ishihara chart.
排除标准
- •Any history brain secondary causes of cognitive impairment (like history of stroke, brain injury, exposure to toxins or neuroleptics, history of neurological disease, dementia, Alzheimer’s disease or any neurological illness with significant cognitive impairment).
- •Dementia will be ruled out with MoCA score ≤
- •Patients on any drugs other than antidepressants that can affect cardiac autonomic functions like antihistaminics, cough or cold medications, diuretics, sympathomimetics, parasympathomimetics will be excluded from the study.
- •Any history of cardiac disease, allergy or non-acceptance of diet proposed.
结局指标
主要结局
Improvement in cognitive, autonomic, inflammatory markers with reduction in depression scores.
时间窗: baseline and after 4, 8, and 12 weeks
次要结局
未报告次要终点
研究者
Dr Ashlesh Patil
AIIMS Nagpur