Efficacy of a Sattva-Enhancement Intervention on Interpersonal and Executive Functioning: A Randomized Controlled Trial among Adults with Common Mental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
The primary purpose of this study is to conduct a Sattva-Enhancement Intervention on patients with Depression (Mild-Mod) and Anxiety diagnoses to evaluate its impact on Interpersonal Functioning. The study also seeks to examine the effect of this intervention on Executive Functioning, Psychological Distress and Well- Being. This study is a randomized controlled trial (RCT) where one group will receive the Sattva-Enhancement Intervention, which consists of 12 individual sessions spread over 8 weeks. The other group will receive Treatment as Usual (TAU), which includes psychoeducation and standard clinical care such as information on illness management, healthy routines, and stress reduction. Caregivers will also be approached to provide information regarding patient’s condition.
The Sattva-Enhancement Intervention is a structured psychological program delivered in a religiously neutral, culturally sensitive manner. It focuses on self-discovery and inner experiences, and strengthens positive inner qualities that support well-being. Sessions integrate reflective discussion, guided meditation, and simple home-based practices. The intervention is informed by classical Indian psychological and yogic frameworks, including concepts drawn from the Yoga Vasishta, Bhagavad Gita, and Patanjali Yoga Sutra. The program includes self-care and inner discipline practices aligned with Niyama, and promotes ethical and adaptive behavioural orientations aligned with Yama. It also emphasizes cultivating the four relational attitudes known as Chaturbhavana, namely maitri (friendliness), karuna (compassion), mudita (sympathetic joy), and upeksha (equanimity), to foster healthier social interactions, emotional balance, improved cognitive control, and flexible responding in interpersonal situations.
This study advances applied Indian psychology, addressing gaps in cultural congruence and holistic treatment. The intervention simultaneously targets interpersonal and executive functioning, symptom reduction, and overall psychological recovery, contributing to enhanced quality of life. The study will validate the therapeutic relevance of certain interconnected indigenous constructs (Sattva, Yama-Niyama, Chaturbhavana), utilizing both standardized Western psychometric instruments and indigenous tools, enhancing their conceptual coherence and applicability. Outcomes from this study will significantly advance culturally congruent interventions within India’s mental health system, providing a validated foundation for scalable, accessible treatments suitable for diverse populations experiencing Depression and Anxiety.
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
- •Patients (with Depression and/or Anxiety):
- •Diagnosed with CMDs based on DSM-5/ICD 11 criteria.
- •Common mental disorders (CMDs) for study includes, depression, and anxiety spectrum disorders, with Axis II status documented and treated as a covariate
- •Aged between 18 and 55 years.
- •Minimum ten years of formal education and ability to provide informed consent and participate in the intervention and assessments.
- •Fluency in English Language, with ability to comprehend English text in assessment tools and respond to it
- •Stabilized on medication for four weeks prior to the entry into the study
- •Willingness to maintain stable medication regimen for the duration of the 8 week intervention.
- •Any change will result in exclusion from final analysis.
排除标准
- •A primary diagnosis of Psychosis, Schizoaffective disorder, Bipolar affective disorder (current episode mania), Current episode of severe depression with or without psychotic symptoms
- •Trauma-related disorders like PTSD, and OCD
- •Adults with active suicidal ideation or attempts
- •History and clinical impression suggestive of intellectual disability
- •History suggestive of any debilitating medical/ neurological/ neurosurgical/ general medical illness etc requiring priority management or which could interfere with assessment or therapy
- •Planned changes to medication regimen during the intervention period.
- •Adults who have received a structured psychological intervention of more than 8 sessions in the past six months for depression or anxiety
- •Adults who are currently undergoing any structured psychotherapeutic treatment.
研究者
Tara M Hari
National Institute of Mental Health and Neuro Sciences
