- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07610928
Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms
2026년 7월 10일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
70
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility of Recruitment, Eligibility Criteria, SMART-QTC and Control Interventions, and Videoconferencing Procedures
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Health Questionnaire-15 (PHQ-15)
기간: 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
|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 15일
기본 완료 (추정된)
2027년 3월 31일
연구 완료 (추정된)
2027년 8월 31일
연구 등록 날짜
최초 제출
2026년 5월 7일
QC 기준을 충족하는 최초 제출
2026년 5월 20일
처음 게시됨 (실제)
2026년 5월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026P001034
- 1R34AT012922-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .