このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

うつ病のためのTCM健康維持 (TCMHPFD)

2026年9月21日 更新者:The Hong Kong Polytechnic University

うつ病に対する漢方薬の健康維持介入:パイロット無作為対照試験

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.

調査の概要

研究の種類

介入

入学 (実際)

31

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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

介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in the Patient Health Questionnaire (PHQ-9)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in the Generalized Anxiety Disorder-7 (GAD-7)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in the Credibility/ Expectancy Questionnaire (CEQ)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年8月1日

一次修了 (実際)

2024年1月30日

研究の完了 (実際)

2024年1月30日

試験登録日

最初に提出

2023年3月23日

QC基準を満たした最初の提出物

2023年3月23日

最初の投稿 (実際)

2023年4月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2023年3月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TCMHPFD
  • No.21B2/004A (その他の助成金/資金番号:the Chinese Medicine Development Fund, Hong Kong Special Administrative Region, China)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

No time restriction for the data availability

IPD 共有アクセス基準

The individual participant data will be available upon request

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する