Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

10 lipca 2026 zaktualizowane przez: Albert Yeung, Massachusetts General Hospital

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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Szacowany)

70

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Eksperymentalny: SMART-QTC
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Feasibility of Recruitment, Eligibility Criteria, SMART-QTC and Control Interventions, and Videoconferencing Procedures
Ramy czasowe: From screening to the end of assessments at week 12
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
Ramy czasowe: From enrollment to the end of assessments at week 12
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient Health Questionnaire-15 (PHQ-15)
Ramy czasowe: From screening to the end of assessments at week 12
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
Ramy czasowe: From screening to the end of assessments at week 12
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 sierpnia 2026

Zakończenie podstawowe (Szacowany)

31 marca 2027

Ukończenie studiów (Szacowany)

31 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

7 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 maja 2026

Pierwszy wysłany (Rzeczywisty)

28 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 lipca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj