NCT07610928尚未招募不适用
Integrating the Stress Management and Resiliency Training (SMART) With Qigong/Tai Chi (QTC) to Develop a Holistic Treatment for Asian Americans With Depression and Distressing Somatic Symptoms
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
研究概览
简要总结
Many Asian Americans with depression also struggle with physical symptoms-such as pain, fatigue, or other forms of bodily discomfort-that occur at the same time. Right now, there is no proven treatment that effectively addresses both the depression and these physical symptoms together. This study will test whether it is practical, acceptable, and safe to combine the Stress Management and Resiliency Training (SMART) program with meditative movements for people who have both major depression and these distressing physical symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identify as being of Asian ethnicity
- •English language proficiency
- •Be ≥18 years of age
- •Satisfy DSM-5 criteria for MDD prior to the initiation of the study intervention, as determined by a clinical interview conducted by the Principal Investigator (PI) during screening using DSM-5 diagnostic criteria.
- •A baseline of the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression score ≥ 16
- •A baseline score of PHQ-15 ≥10
- •Have not had Tai Chi/Qigong training/practice or other forms of mind-body intervention (e.g. yoga, mindfulness training, muscle relaxation training, etc) more than once a week in the past 3 months
- •A total score 24 or higher in Mini-Mental Status Examination for cognitive ability (if the participant endorses a history of cognitive impairment).
- •Willing to keep any psychiatric medications and psychotherapy stable throughout the course of the study (from Week 0 baseline to Week 12 Follow-up)
- •Have access to a device (i.e., smartphone, iPad, personal computer) and a stable network to attend the online group sessions
- •Ability to perform daily physical activity
排除标准
- •Have a primary psychiatric diagnosis other than MDD
- •Any history of psychosis, mania, or impulsivity and difficulty relating to people and judged by the clinician not appropriate for group intervention
- •Active eating disorder or substance use disorder within the last 6 months
- •Any relevant medical conditions that may be the medical basis of depression including thyroid diseases, epilepsy, history of an abnormal EEG, severe head trauma, or stroke
- •Have serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that in the opinion of the investigators represents a risk to the subject, including presence of a pacemaker, cardiac arrhythmia, fever, weakness and hypotension, or vagal nerve stimulator
- •current active suicidal or self-injurious potential (i.e., PHQ-9 item 9 ≥1 and/or a positive response to C-SSRS screener items 3, 4, 5, or 6), and assessed by the clinician necessitating immediate treatment
- •Participant who are or who plan to receive confounding treatments (including treatment of endocrinopathies): use of antidepressants, complementary and alternative medical (CAM) treatments thought to have beneficial effects on mood, including St. John's Wort, S-Adenosyl methionine (SAMe), omega-3 fatty acids, light therapy, conventional psychotherapy, mind-body interventions (e.g. Qigong, mindfulness training, muscle relaxation training, etc.)
- •Electroconvulsive therapy (ECT) during the last year as these patients are often among the more refractory and are not optimal candidates for CAM
- •History of refractory to treatment with ≥3 failed antidepressant trials in current depressive episode
- •Participated in other depression-related clinical trials within the past 3 months
- •Antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
- •Psychotherapy that has been initiated within the past 3 months
研究组 & 干预措施
Healthy Living Program
Active Comparator
干预措施: Healthy Living Program (Behavioral)
SMART-QTC
Experimental
干预措施: Stress Management and Resiliency Training with Qigong/Tai Chi (Behavioral)
研究者
Albert Yeung
Clinician Investigator, Full Professor
Massachusetts General Hospital
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