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

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

80

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

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

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

20년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
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.
Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.
활성 비교기: Stress management plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
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.
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
활성 비교기: 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.
Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
활성 비교기: Psychoeducation leaflet plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
기간: 13 weeks
13 weeks
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
기간: 52 weeks
52 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
기간: 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)
기간: 13 weeks
13 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
기간: 52 weeks
52 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
기간: 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)
기간: 13 weeks
13 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
기간: 52 weeks
52 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
기간: 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)
기간: 13 weeks
13 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
기간: 52 weeks
52 weeks
Insomnia severity: Insomnia Severity Index (ISI)
기간: 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)
기간: 13 weeks
13 weeks
Insomnia severity: Insomnia Severity Index (ISI)
기간: 52 weeks
52 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
기간: 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)
기간: 13 weeks
13 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
기간: 52 weeks
52 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
기간: 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)
기간: 13 weeks
13 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
기간: 52 weeks
52 weeks
Burnout: Maslach Burnout Inventory (MBI)
기간: 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)
기간: 13 weeks
13 weeks
Burnout: Maslach Burnout Inventory (MBI)
기간: 52 weeks
52 weeks
Quality of Life: EuroQol (EQ-5D)
기간: 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)
기간: 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)
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Adverse events
기간: 13 weeks
Information about any possible adverse events will be collected during the intervention period.
13 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Norio Watanabe, MD, PhD, Kyoto University

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)

2014년 6월 11일

기본 완료 (실제)

2016년 3월 2일

연구 완료 (실제)

2016년 9월 6일

연구 등록 날짜

최초 제출

2014년 5월 27일

QC 기준을 충족하는 최초 제출

2014년 5월 27일

처음 게시됨 (추정)

2014년 5월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 20일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IRG-NP-NCNP-25-8

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

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. .

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