Yoga as a complementary intervention for children and adolescents with depression: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in depression symptoms as measured on validated rating scales for depression, such as the DASS-Y (Depression Anxiety Stress Scales – Youth Version) and CES-DC (Center for Epidemiological Studies Depression Scale for Children), after 8 weeks of yoga intervention
研究概览
简要总结
The planned study aims to evaluate yoga as a complementary therapy for the treatment of depression in children and adolescents. Depression in young people is linked to developmental, cognitive, and social difficulties, as well as an increased risk of self-harm and persistence into adulthood. Pharmacological treatments, though effective, are limited by concerns regarding side effects such as increased suicidal ideation and behavior. Psychotherapeutic interventions remain resource-intensive, requiring trained professionals and regular sessions, which restricts their accessibility in low- and middle-income settings. Yoga, an ancient Indian practice, has emerged as a promising complementary approach for mental health conditions, including depression. It integrates physical postures (asanas), controlled breathing (pranayama), and mindfulness-based practices, providing a holistic balance of physical and psychological well-being. However, research evaluating its use in children and adolescents within clinical settings remains limited. This study therefore seeks to assess the efficacy of an 8-week yoga intervention as a complementary therapy for depression in children and adolescents. The yoga intervention will be delivered alongside standard care, compared against a control group receiving only standard care. By addressing current research gaps, the study aims to establish yoga as a culturally relevant, scalable, and accessible mental health intervention for youth depression.
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
- 8.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Children and adolescents from the ages of 8 to 17 years
- •Patients having an established clinical diagnosis of major depressive disorder as per DSM-5 criteria, with mild to severe depression, without active suicidal ideation or behaviour, and without psychotic symptoms.
- •The clinician’s diagnosis of depression shall be confirmed on K-SADS-PL.
- •Access to internet-based video-conferencing applications.
- •Ability to understand, read and write English, Hindi and/or Punjabi.
- •Written informed consent from the parents/guardians and assent from the study participants.
排除标准
- •Psychiatric comorbidity such as bipolar disorder, psychosis, active anxiety disorders, substance use disorders, eating disorders, neurodevelopmental disorders.
- •Active suicidal ideation to the extent that it may interfere with the administration of yoga.
- •Major depressive disorder with psychotic features.
- •Severe medical or neurological conditions which limit the ability to do yoga.
- •History of participation in yoga in the past six months.
- •Inability to take part in the scheduled intervention sessions because of logistical challenges.
结局指标
主要结局
Change in depression symptoms as measured on validated rating scales for depression, such as the DASS-Y (Depression Anxiety Stress Scales – Youth Version) and CES-DC (Center for Epidemiological Studies Depression Scale for Children), after 8 weeks of yoga intervention
时间窗: Baseline and 8 weeks
次要结局
- To assess the intervention’s impact on depression symptoms.(For the yoga intervention group:)
- To assess the intervention’s impact on quality of life of children and adolescents with depression, and to document any adverse effects of the yoga intervention.(For the yoga intervention group:)
研究者
Dr Mirza Sarwar Baig
Postgraduate Institute of Medical Education and Research, Chandigarh