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우울증에 대한 TCM 건강 보존 (TCMHPFD)

2026년 9월 21일 업데이트: The Hong Kong Polytechnic University

우울증에 대한 중국 전통 의학 건강 보존 개입: 파일럿 무작위 통제 시험

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

31

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

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
실험적: 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

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in the Patient Health Questionnaire (PHQ-9)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in the Generalized Anxiety Disorder-7 (GAD-7)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Change in the Credibility/ Expectancy Questionnaire (CEQ)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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 (실제)

2023년 8월 1일

기본 완료 (실제)

2024년 1월 30일

연구 완료 (실제)

2024년 1월 30일

연구 등록 날짜

최초 제출

2023년 3월 23일

QC 기준을 충족하는 최초 제출

2023년 3월 23일

처음 게시됨 (실제)

2023년 4월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2023년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TCMHPFD
  • No.21B2/004A (기타 보조금/기금 번호: the Chinese Medicine Development Fund, Hong Kong Special Administrative Region, China)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

No time restriction for the data availability

IPD 공유 액세스 기준

The individual participant data will be available upon request

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

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. .