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Happy Nurse Project: Lifestyle Interventions to Maintain Healthy Mental State in Hospital Nurses (HNP)

2018年8月20日 更新者：National Center of Neurology and Psychiatry, Japan

Mindfulness-Based Stress Management Program and Omega-3 Fatty Acids to Maintain Healthy Mental State in Hospital Nurses: Multi-Center Factorial-Design Randomized Controlled Trial Happy Nurse Project

The study is to explore the effectiveness of omega-3 fatty acids and mindfulness-based stress management program to maintain healthy mental state in hospital nurses. The participants will be junior nurses who work in inpatient wards and are not clinically depressed. The participants will be randomly allocated to four intervention arms: 1) Mindfulness-based stress management program plus omega-3 fatty acids pills ; 2) Mindfulness-based stress management program plus placebo pills; 3) Psychoeducation leaflet plus omega-3 fatty acids pills; and 4) Psychoeducation leaflet plus placebo pills. Thirty participants will be allocated to each arm. These interventions will terminate until three months from registration for each participant.

Information about depression and anxiety symptoms (primary outcome), insomnia, burnout, presenteeism, quality of life, sick leave, consultation about mental state of herself, and oxidative stress will be collected at 3 months, 6 months (primary time point) and 12 months from registration for each participant.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The study is to explore the effectiveness of omega-3 fatty acids and mindfulness-based stress management program to maintain healthy mental state in hospital nurses. The participants will be junior nurses who work in inpatient wards at four general hospitals in Tama region in Tokyo, and are not clinically depressed based on the score of the Hospital Anxiety and Depression scale. The participants will be randomly allocated to four intervention arms: 1) Mindfulness-based stress management program plus omega-3 fatty acids pills; 2) Mindfulness-based stress management program plus placebo pills; 3) Psychoeducation leaflet plus omega-3 fatty acids pills; and 4) Psychoeducation leaflet plus placebo pills. Thirty participants will be allocated to each arm. These interventions will terminate until 3 months from registration for each participant. Stress management program will be conducted by senior nurses in four individual sessions within these three months. Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

Information about depression and anxiety symptoms (primary outcome), insomnia, burnout, presenteeism, quality of life, numbers of incident and accident at work, sick leave and consultation about mental state of herself, concentration of fatty acids in serum and oxidative stress will be collected at 3 months, 6 months (primary time point) and 12 months from registration for each participant. The primary outcome will be assessed by blind raters through telephone.

The outcomes will be compared between arms including stress management program and those without, and between arms including omega-3 fatty acids and those without, by using mixed model repeated measures model.

研究の種類

介入

入学 (実際)

80

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

  • 日本
      • Kyoto、日本、606-8501
        • Kyoto University
    • Tokyo
      • Kodaira、Tokyo、日本、187-8551
        • National Center of Neurology and Psychiatry

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

20年～59年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

Inclusion Criteria:

  • Work for inpatient wards in among four general hospitals in Tama region, Japan, including: National Center of Neurology and Psychiatry Hospital, National Disaster Medical Center, Tokyo Metropolitan Tama Medical Center, and Tama-Hokubu Medical Center
  • Nurses without administration work
  • Give written consent in the participation of the study

Exclusion Criteria:

  • Have plans to take sick leave, leave for other reasons or retirement within 26 weeks from the entry to the study
  • Take structured psychotherapy (e.g. cognitive behavioral therapy, interpersonal therapy, and brief psychodynamic therapy) at the entry
  • See a physician regularly in order to treat any mood or anxiety disorders primarily at the entry
  • Take antidepressants, mood stabilizers, anticonvulsants or antipsychotics at the entry
  • Have taken nutrient supplement including omega-3 fatty acids for 4 or more weeks within 52 weeks from the entry
  • Clinically depressed, based on the total score of 11 or more on the Hospital Anxiety and Depression Scale - Depression Subscale and the total score of 15 or more on the Primary Health Care Questionnaire
  • Consume 4 times or more of fish as the main course of meal per week
  • Take anticoagulant drugs at the entry or have previous history of stroke or myocardial infarction
  • Judged ineligible by research coordinator due to any reason

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：防止
  • 割り当て：ランダム化
  • 介入モデル：階乗代入
  • 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：Stress management plus omega-3
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
行動：Mindfulness-based stress management program
Mindfulness-based stress management program will be conducted by senior nurses in four individual sessions within these three months. Senior nurses have taken a 7-hour workshop including lectures and role-playing sessions. The detailed manual and videos including lectures will be provided to the senior nurses.
ダイエットサプリメント：Omega-3 fatty acids pills
Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.
アクティブコンパレータ：Stress management plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
行動：Mindfulness-based stress management program
Mindfulness-based stress management program will be conducted by senior nurses in four individual sessions within these three months. Senior nurses have taken a 7-hour workshop including lectures and role-playing sessions. The detailed manual and videos including lectures will be provided to the senior nurses.
ダイエットサプリメント：Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
アクティブコンパレータ：Psychoeducation leaflet plus omega-3
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
ダイエットサプリメント：Omega-3 fatty acids pills
Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.
行動：Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
アクティブコンパレータ：Psychoeducation leaflet plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
ダイエットサプリメント：Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
行動：Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

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
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
時間枠：26 weeks
The total score of the HADS (HADS-T) ranges from 0 to 42, with higher scores indicating more symptoms. The HADS has two sub scores, each ranging from 0 to 21: HADS-D (depression) and HADS-A (anxiety). The total score will be used as the severity of depression and anxiety symptoms in the present study.
26 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
時間枠：13 weeks
13 weeks
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
時間枠：52 weeks
52 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
時間枠：26 weeks
Major depressive episode will be ascertained using the Primary Care Evaluation of Mental Disorders (PRIME-MD) algorithm with the depression module of the Patient Health Questionnaire (PHQ-9). The PHQ-9 was developed as a self-report version of the PRIME-MD which aims at Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) diagnosis of several common mental disorders.
26 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
時間枠：13 weeks
13 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
時間枠：52 weeks
52 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
時間枠：26 weeks
Personal Health Questionnaire-9 is a 9-item structured questionnaire to measure depression severity.
26 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
時間枠：13 weeks
13 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
時間枠：52 weeks
52 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
時間枠：26 weeks
The GAD-7 consists of 7 items, and the total score ranges from 0 to 21.
26 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
時間枠：13 weeks
13 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
時間枠：52 weeks
52 weeks
Insomnia severity: Insomnia Severity Index (ISI)
時間枠：26 weeks
The ISI is now considered a standard measure of the global severity of insomnia and used in many studies. The total score between 8-14 indicates subthreshold insomnia; and 15-28, clinical insomnia. The total score of the ISI will be used as the severity of insomnia in the study.
26 weeks
Insomnia severity: Insomnia Severity Index (ISI)
時間枠：13 weeks
13 weeks
Insomnia severity: Insomnia Severity Index (ISI)
時間枠：52 weeks
52 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
時間枠：26 weeks
The BSI is a 44-item questionnaire for females about symptoms experienced in the previous month, which was designed to detect physical symptoms commonly related to depressed patients.
26 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
時間枠：13 weeks
13 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
時間枠：52 weeks
52 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
時間枠：26 weeks
The HPQ is a self-report instrument designed to estimate the workplace costs of health problems in terms of self-reported reduced job performance (presenteeism).
26 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
時間枠：13 weeks
13 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
時間枠：52 weeks
52 weeks
Burnout: Maslach Burnout Inventory (MBI)
時間枠：26 weeks
The MBI is a self-report measure with 22 items and is calculated into three sub-domains such as emotional exhaustion, depersonalization and personal accomplishment.
26 weeks
Burnout: Maslach Burnout Inventory (MBI)
時間枠：13 weeks
13 weeks
Burnout: Maslach Burnout Inventory (MBI)
時間枠：52 weeks
52 weeks
Quality of Life: EuroQol (EQ-5D)
時間枠：26 weeks
EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments.
26 weeks
Quality of Life: EuroQol (EQ-5D)
時間枠：13 weeks
EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments.
13 weeks
Quality of Life: EuroQol (EQ-5D)
時間枠：52 weeks
EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments.
52 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Adverse events
時間枠：13 weeks
Information about any possible adverse events will be collected during the intervention period.
13 weeks

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。

スポンサー

National Center of Neurology and Psychiatry, Japan

捜査官

  • 主任研究者：Norio Watanabe, MD, PhD、Kyoto University

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。

一般刊行物

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)

2014年6月11日

一次修了 (実際)

2016年3月2日

研究の完了 (実際)

2016年9月6日

試験登録日

最初に提出

2014年5月27日

QC基準を満たした最初の提出物

2014年5月27日

最初の投稿 (見積もり)

2014年5月30日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月22日

QC基準を満たした最後の更新が送信されました

2018年8月20日

最終確認日

2018年8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

  • IRG-NP-NCNP-25-8

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?

未定

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。

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