Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a stress management program called SMART combined with meditative movements. It will check if this approach is practical, safe, and acceptable for Asian American adults with major depression and physical symptoms, such as pain or tiredness.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Identify as Asian, be at least 18 years old, and be able to use English.
- Have major depression confirmed by the study doctor during a screening interview.
- Score at least 16 on the PROMIS depression survey and at least 10 on the PHQ-15 physical symptom survey.
- Have practiced Tai Chi, Qigong, yoga, mindfulness, or similar mind-body activities no more than once a week in the past 3 months.
- If you report past problems with memory or thinking, score at least 24 on a mental skills test.
- Be willing to keep mental health medicines and talk therapy unchanged from the start of the study through week 12.
- Have a smartphone, tablet, or computer and a stable internet connection for online group sessions.
- Be able to do daily physical activity.
Who can't join
- Have a main mental health diagnosis other than major depression; or a history of losing touch with reality, extreme high moods, or impulsive behavior and trouble relating to others that the doctor finds unsuitable for group sessions.
- Have an active eating disorder or a substance use disorder within the past 6 months.
- Have a health condition that may cause depression, such as thyroid disease, epilepsy, an abnormal brain-wave test, a serious head injury, or a stroke.
- Have a serious uncontrolled illness or another health risk, such as poorly controlled diabetes, severe heart failure, an irregular heartbeat, fever, weakness with low blood pressure, a pacemaker, or an implanted vagus nerve stimulator.
- Have a current risk of suicide or self-harm that the doctor says needs immediate treatment.
- Receive or plan treatments that could affect the study results. The listing includes antidepressants, talk therapy, mind-body practices, light therapy, mood-related supplements, and treatment for hormone disorders.
- Have had electroconvulsive therapy (ECT, a treatment using electrical pulses) in the past year, or tried at least 3 antidepressant treatments without success during the current period of depression.
- Joined another depression study in the past 3 months; started mental health medicine less than 8 weeks before screening; changed its dose less than 4 weeks before screening; or started talk therapy within the past 3 months.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study sites (1)
MA
- Depression Clinical and Research Program · Boston, MA 02114Yian (Sherry) Wu · Study contact · 6176433370 · yiwu4@mgh.harvard.eduMore trials in Boston