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TCM Preservación de la Salud para la Depresión (TCMHPFD)

21 de septiembre de 2026 actualizado por: The Hong Kong Polytechnic University

Intervención de preservación de la salud de la medicina tradicional china para la depresión: un ensayo piloto controlado aleatorizado

This study aims to evaluate the feasibility and preliminary effects of Traditional Chinese Medicine (TCM) health preservation for depression on depressive symptoms reduction and other health-related outcomes among Hong Kong Chinese adults with depression. Participants in intervention group will receive TCM health preservation course for six weeks (6 sessions, 2 hours each) and practice TCM health preservation during the 6-week follow-up period. Participants in the control group (waitlist control) will receive usual care. After the follow-up assessment, TCM health preservation courses for depression will be provided to them for compensation.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

31

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Hong Kong, Hong Kong
        • School of Nursing, the Hong Kong Polytechnic University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Hong Kong Chinese adults aged 18-years-old to 65-years-old;
  • diagnosed with moderate level of depression (a score of 10~20), evaluated by the Patient Health Questionnaire-9 (PHQ-9);
  • can communicate in spoken Cantonese and written Chinese;
  • willing to provide written informed consent and be able to adhere to the study protocol.

Exclusion Criteria:

  • being pregnant or during the lactation, or plan to get pregnant;
  • new onset or change of antidepressant medication or dosage in the last 3 months;
  • PHQ-9 score≥20, meaning a severe level of depression;
  • with a previous or present diagnosis of psychotic disorders as screened by the Chinese version of the Structured Clinical Interview for DSM-IV;
  • the score of Hong Kong Montreal Cognitive Assessment less than 22;
  • significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3);
  • with diagnosis of illness which can interfere the individuals to participate or adhere to the modified lifestyle;
  • with diagnosis of medical conditions, which are not suitable to modify diet or do physical activities recommended by physicians;
  • joining in another clinical trial during the study period;
  • with any major medical condition that causes depression based on the judgement of the investigator.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: traditional Chinese medicine health preservation group

The participants in the traditional Chinese medicine health preservation group will attend six traditional Chinese medicine health preservation courses (2h each per one, for 6 weeks) to learn and experience traditional Chinese medicine health preservation from a registered traditional Chinese medicine practitioner in a classroom at the School Nursing, the Hong Kong Polytechnic University.

Each class will be conducted in a small group of 4 to 6 participants to enhance interaction and ensure the quality of teaching. Participants will then practice traditional Chinese medicine health preservation at home for 6 weeks.

The traditional Chinese medicine health preservation intervention for depression was developed based on a previous systematic review and meta-analysis of Traditional Chinese medicine based integrated health interventions for depression, traditional Chinese medicine health preservation textbooks, clinical practice guidelines related to traditional Chinese medicine health preservation and traditional Chinese medicine treatment for depression. The content and structure of traditional Chinese medicine health preservation for depression was achieved among Hong Kong traditional Chinese medicine experts via a Delphi study.

Usual care

Sin intervención: Waitlist control group

Participants in the waitlist control group will receive usual care during the 6-week waitlist period of intervention, and 6-week waitlist period of follow-up. After the follow-up assessment, they will be provided an equivalent traditional Chinese medicine health preservation for depression.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the Patient Health Questionnaire (PHQ-9)
Periodo de tiempo: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

The PHQ-9, a self-rated questionnaire to assess the presence and severity of depressive symptoms of an individual during the last 2 weeks on a scale of 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. A higher score indicates a higher severity of depression symptoms.

Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

The GAD-7 is a four-point Likert scale for identifying probable cases of GAD and assess the severity of symptoms of GAD for the past 2 weeks. The total score of GAD-7 varies from 0 to 21, and responses include "nearly every day," "more than half the days," "several days", and "not at all". The cutoff point of 5, 10, and 15 of GAD-7 might be interpreted as showing mild, moderate, and severe levels of anxiety. Higher scores indicate more severe GAD symptoms.

Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Perceived Stress Scale (PSS-10)
Periodo de tiempo: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

The PSS-10 is a 10-item scale that is often used for measuring perceived psychological stress. Each item is rated on a 5-point Liket scale during the past month, referring to "4" as "very often" and "0" as never. The total score changes from 0 to 40, with a higher score meaning a higher perceived psychological stress level.

Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Insomnia Severity Index (ISI)
Periodo de tiempo: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

The ISI is a seven-item self-rating scale to assess the severity of insomnia, distress, and functional impairment associated with insomnia on a 5-point Likert scale. The score of each item of ISI ranges from 0 (no problem) to 4 (very severe problem), and the total score is interpreted as below: absence of insomnia as 0 to 7, sub-threshold insomnia as 8 to14, moderate insomnia as 15 to 21, and severe insomnia as 22 to 28.

Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Fatigue Assessment Scale (FAS)
Periodo de tiempo: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

The FAS is a 10-item scale that evaluates symptoms of chronic fatigue with a five-point Likert-type scale, which ranges from 1 ("never") to 5 ("always"). A higher score means greater fatigue severity. The total score ranges from 10 to 50. A total FAS score < 22 means no fatigue, a score≥ 22 refers to fatigue.

Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Short-Form (six-dimension) Health Survey (SF-6D)
Periodo de tiempo: Time Frame: Baseline, week 6, week 8, week 12

The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life. Higher scores indicate better health status.

Time Frame: Baseline, week 6, week 8, week 12
Change in the General Self-Efficacy Scale (GSE)
Periodo de tiempo: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

The GSE scale is a four-point Likert scale with ten items appropriate for evaluating an individual's self-efficacy. It is scored ranging from 1 point to 4 points, referring to "not at all true" to "exactly true" and the total score varied from 10 to 40. A higher score shows a more satisfactory self-efficacy.

Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Health-Promoting Lifestyle Profile II (HPLP II)
Periodo de tiempo: Time Frame: Baseline, week 4, week 6, week 8, week 12

The HPLP II is a scale with 52 items and 6 domains for measuring health-promoting behavior, defined as a multidimensional pattern of self-initiated perceptions and actions that serve to maintain or increase the level of self-actualization, wellness, and fulfillment of a person. The total scores of HPLP-II varies from 52 to 208. Higher HPLP II score denotes better level of health-promoting lifestyle.

Time Frame: Baseline, week 4, week 6, week 8, week 12

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the Credibility/ Expectancy Questionnaire (CEQ)
Periodo de tiempo: Time Frame: Baseline, week 6

The CEQ is a self-reported scale with 6 items and two subscales of treatment credibility and outcome expectancy to measure the participants' treatment credibility and outcome expectancy for improvement. The final scoring of the CEQ is computed by the sum of the items composing each subscale, with a higher quotation referring to higher treatment credibility and outcome expectation.

The CEQ taps on participants' affective and cognitive evaluations of treatment satisfaction, credibility, and expectation. The subscale of credibility assesses beliefs about the treatment strength. The expectancy subscale assesses how participants perceive their symptoms will improve during the intervention period.

Time Frame: Baseline, week 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2023

Finalización primaria (Actual)

30 de enero de 2024

Finalización del estudio (Actual)

30 de enero de 2024

Fechas de registro del estudio

Enviado por primera vez

23 de marzo de 2023

Primero enviado que cumplió con los criterios de control de calidad

23 de marzo de 2023

Publicado por primera vez (Actual)

5 de abril de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Última verificación

1 de marzo de 2023

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TCMHPFD
  • No.21B2/004A (Otro número de subvención/financiamiento: the Chinese Medicine Development Fund, Hong Kong Special Administrative Region, China)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

The individual participant data will be available when the study has been published. The individual participant data will be available upon request.

Marco de tiempo para compartir IPD

No time restriction for the data availability

Criterios de acceso compartido de IPD

The individual participant data will be available upon request

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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