Stress management and meditative movements for depression with physical symptoms in Asian Americans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who identify as Asian and have major depressive disorder with significant physical symptoms will participate in a combined program of Stress Management and Resiliency Training (SMART) and Qigong/Tai Chi, compared to standard care. The trial will evaluate practicality, acceptability, and safety of the combined approach over a fixed period while keeping medications and psychotherapy stable. Participants will undergo clinical interviews, symptom questionnaires, and basic cognitive screening at baseline and follow-ups. The focus is on whether this mind-body combination can address both mood and somatic symptoms in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Depression Clinical and Research Program
  Boston, Massachusetts, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.