Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Stress Management and Resiliency Training with Qigong/Tai Chi
  The SMART-QTC will be an 8-session online intervention with 1.5-hour weekly sessions that include core elements of SMART, including mind-body practice based on RR training, cognitive behavioral skills, and positive psychological skills, with QTC exercises incorporated at the end of every session.
• Поведенческое Healthy Living Program
  The Healthy Living Program is an 8-session program designed to incorporate psychoeducation on a range of key health behaviors and wellness topics, including: the comorbidity between mental and physical illness, sleep, physical exercise, nutrition, and managing health-care needs. The course encourages in-group and at-home self-monitoring and practice of healthy living principles.

Первичные конечные точки

• Feasibility of Recruitment, Eligibility Criteria, SMART-QTC and Control Interventions, and Videoconferencing Procedures [Срок оценки: From screening to the end of assessments at week 12]
• Acceptability of SMART-QTC and Control Interventions and Videoconferencing Procedures [Срок оценки: From enrollment to the end of assessments at week 12]

Вторичные конечные точки (2)

• Patient Health Questionnaire-15 (PHQ-15) [Срок оценки: From screening to the end of assessments at week 12]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form [Срок оценки: From screening to the end of assessments at week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07610928 · 2026P001034 · 1R34AT012922-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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