- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07610928
Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms
10 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
70
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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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Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of Recruitment, Eligibility Criteria, SMART-QTC and Control Interventions, and Videoconferencing Procedures
Prazo: 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
|
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Acceptability of SMART-QTC and Control Interventions and Videoconferencing Procedures
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Health Questionnaire-15 (PHQ-15)
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de agosto de 2026
Conclusão Primária (Estimado)
31 de março de 2027
Conclusão do estudo (Estimado)
31 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
7 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de maio de 2026
Primeira postagem (Real)
28 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de julho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026P001034
- 1R34AT012922-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .