An interventional study of Stress Management and Resiliency Training with Qigong/Tai Chi and Healthy Living Program in Depression / Major Depressive Disorder and Mental Health (Depression), sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 70 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Healthy Living Program
Behavioral: 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.
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.
Feasibility of Recruitment, Eligibility Criteria, SMART-QTC and Control Interventions, and Videoconferencing Procedures
Recruitment feasibility targets are: \>=70% consent to screening, \>=70% meeting screening criteria, \>=70% of eligible individuals enrolling, and enrollment of \>=20 participants/month. Eligibility feasibility will include the proportion ineligible due to each criterion (\<20%), reasons for ineligibility, reasons for refusal, and characteristics of refusers. SMART-QTC and control intervention feasibility will include adherence (\>=75% session attendance), retention (\>=75% completion of post-assessments and \>=70% completion of follow-up assessments), fidelity (checklist score \>=80%), and home practice completion (\>=75% completing home practice at least 3 days/week). Videoconferencing feasibility will include \<20% dropped connections, \<20% missed sessions due to technical problems, mean number of technical problems \<2.0, types of technical problems, and \<20% requesting extra training, type of extra training needed.
Time frame: From screening to the end of assessments at week 12
Acceptability of SMART-QTC and Control Interventions and Videoconferencing Procedures
Acceptability of SMART-QTC and control interventions will be assessed using post-session surveys, post-intervention surveys, exit interviews, and follow-up surveys. Outcomes include session satisfaction, helpfulness, enjoyment, relevance, and utility of each session component rated on a 5-point scale (1=not at all to 5=very much; mean \>=3.75). Overall program satisfaction, likelihood of continued skill use, and willingness to recommend the program to others will also target mean ratings \>=3.75 on a 5-point scale. Exit interviews will assess likes, dislikes, and suggestions for improvement. \>=60% of participants continuing meditation practice at follow-up. Videoconferencing acceptability will include ease and confidence of use (1=not at all, 5=extremely, mean \>=3.75), interference of technical problems (1=none, 5=extreme, mean \<1.0), audiovisual quality and overall satisfaction (1=poor, 5=excellent, mean\>=3.75), and pros and cons and suggestions for improvement.
Time frame: From enrollment to the end of assessments at week 12
Patient Health Questionnaire-15 (PHQ-15)
Somatic symptom severity will be assessed using the Patient Health Questionnaire-15 (PHQ-15), a 15-item self-report measure of physical symptom burden experienced over the past 7 days. Each symptom is scored on a 3-point scale (0-2). Total scores range from 0 to 30, with higher scores indicating greater somatic symptom severity and worse physical symptom burden.
Time frame: From screening to the end of assessments at week 12
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form
Depressive symptoms will be assessed using the PROMIS Depression Short Form, a self-report measure assessing the frequency and severity of depressive symptoms. Participants rate depressive symptoms experienced during the past 7 days on a 5-point scale ranging from 1 (never) to 5 (always). Raw total scores range from 8 to 40, with higher scores indicating greater severity of depressive symptoms and worse depression.
Time frame: From screening to the end of assessments at week 12
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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