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临床试验/CTRI/2025/07/090085
CTRI/2025/07/090085尚未招募不适用

HEALTH AUGMENTATION VIA PERSONALIZED POSITIVE PSYCHOLOGY AND YOGA (HAPPY) FOR MAJOR DEPRESSIVE DISORDER

BRUNDA YADAV P S1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月31日最近更新:

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
To develop HAPPY Intervention for patients with MDD under the guidance of experts

研究概览

简要总结

This study involves two key phases: intervention development and a pilot controlled trial.

Phase 1 focuses on the development and content validation of the HAPPY protocol. This will be achieved through expert consultations, literature review, and refinement based on feedback from yoga therapists, psychologists, and psychiatrists.

Phase 2 is a pilot controlled trial with 50 participants recruited from NIMHANS’ IPD service in psychiatry and integrative medicine. Participants meeting the inclusion criteria, such as age between 18 and 50 years and being on stable medication for depression for at least six weeks.

The intervention group will follow the HAPPY protocol, which includes activities of Raja Yoga, Karma Yoga, Jnana Yoga and Bhakti Yoga like mindful movement, gratitude meditation, and Guna assessments, while the control group will participate in the validated Depression Yoga module.

The control provides a standard against which the effects of the HAPPY intervention can be measured. By comparing the intervention group (HAPPY) to the control group (using the validated Depression Yoga module), we can assess whether the HAPPY intervention offers additional or unique benefits over the existing standard.

Each participant in HAPPY intervention will have 10-15 minute, therapist-supervised sessions over two weeks, either inpatient or outpatient depending on their preference.

The study will measure multiple outcomes using validated assessment tools such as The Hamilton Depression Rating Scale, WHO Well-being Scale, Five Facet mindfulness questionnaire, Pittsburg sleep quality index, Perceived Stress Scale, Yoga Practice Performance Assessment

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

  • Patients with MDD aged between 18 and 50 years Patients under stable medications for depression in the last 6 weeks.

排除标准

  • Comorbid with substance use except Nicotine Comorbid with OCD Comorbid with psychotic disorders Cognitive impairment Organic mood disorders Patients who have been practising yoga regularly in the last month.

结局指标

主要结局

To develop HAPPY Intervention for patients with MDD under the guidance of experts

时间窗: 3 months | 3 months | 1 year

To validate the developed HAPPY intervention from experts

时间窗: 3 months | 3 months | 1 year

To check the feasibility of the developed HAPPY Intervention in a pilot controlled trial in MDD patients

时间窗: 3 months | 3 months | 1 year

次要结局

  • To check the limited efficacy of the HAPPY intervention by assessing MDD patients pre and post intervention
  • To study the changes in the following variables when HAPPY is added along with pharmacotherapy for patients with MDD:

研究者

发起方
BRUNDA YADAV P S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

BRUNDA YADAV P S

National Institute of Mental Health and Neurosciences

研究点 (1)

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