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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health (Depression); Depression / Major Depressive Disorder
• Intervention / Treatment: Behavioral: Healthy Living Program; Behavioral: Stress Management and Resiliency Training with Qigong/Tai Chi

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 the Mini International Neuropsychiatric Interview (MINI) interview
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Living Program	Behavioral: 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.
Experimental: SMART-QTC	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to the end of assessments at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From screening to the end of assessments at week 12

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Asian American; Somatic symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Medically Unexplained Symptoms; Depression; Depressive Disorder, Major; Psychological Well-Being
• Other Study ID Numbers: 2026P001034; 1R34AT012922-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No