A double-blind, double-dummy, randomized, placebo-controlled factorial trial of individualized homoeopathic medicines and cognitive behavioural therapy in reducing depression, anxiety and stress in adolescents and young adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- DASS-21 (Depression, Anxiety and Stress Scale – 21)
研究概览
简要总结
Stress, anxiety, and depression are common among adolescents and young adults. This affects their psychological health and may cause a sociocultural imbalance. Recently a cross-sectional survey identified a high prevalence of depression, anxiety, and stress among undergraduate and postgraduate students. The effects of integrating homeopathy with CBT need to be evaluated in a gold-standard design (i.e., a randomized controlled trial) to reduce depression, stress, and anxiety in adolescents and young adults. This research on 200 adolescents and young adults is aimed at reducing depression, anxiety, and stress with homeopathic medicines, cognitive behavioral therapy, or both, using a 6-month, double-blind, double-dummy, randomized, placebo-controlled design at D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by evaluating the DASS-21 score as the primary outcome and the PHQ-9 as the secondary outcome. Comparative analysis will be carried out on the intention-to-treat (ITT) basis to detect group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 12.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Cases suffering from depression, stress, and anxiety, diagnosed as per DSM-V criteria.
- •b) Age between 12 and 30 years c) Participants of either sex d) Literate patients’ ability to read and write in English, Hindi, or Bengali.
- •e) Providing with written informed consent voluntarily.
排除标准
- •a) Severe or very severe depression (HDRS more than 19) with suicide attempt b) Patients with other psychiatric diseases, e.g., schizophrenia or other psychotic disorders, bipolar affective disorder, schizoaffective disorders, alcohol or other substance abuse, eating disorders, psychosis, mania, hypomania or any other anxiety disorder except panic disorder, personality disorders, history of seizures c) A clinically significant acute or chronic disease that would hinder regular participation in the study d) Treatment with antipsychotics, antidepressants, sedatives/hypnotics or mood stabilizers four weeks prior to the screening e) Complementary or alternative treatment used simultaneously to the study (e.g., acupuncture, phytotherapy, psychotherapy, etc.) f) Homeopathic treatment for any chronic diseases eight weeks prior to study entry g) Cases suffering from uncontrolled systemic illness or life-threatening infections h) Vulnerable population: unconscious, ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •i) Self-reported immune-compromised state j) Pregnant and puerperal women, lactating mothers k) Patient under tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence l) Simultaneous participation in any other clinical trial.
结局指标
主要结局
DASS-21 (Depression, Anxiety and Stress Scale – 21)
时间窗: Baseline, after 3 months, and 6 months
次要结局
- PHQ-9 (Patient Health(Questionnaire))