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

20 août 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 59 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Complément alimentaire: 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.
Comparateur actif: Stress management plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
Comportemental: 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.
Complément alimentaire: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Comparateur actif: 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.
Complément alimentaire: 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.
Comportemental: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
Comparateur actif: Psychoeducation leaflet plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
Complément alimentaire: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Comportemental: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Délai: 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

Mesures de résultats secondaires

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Adverse events
Délai: 13 weeks
Information about any possible adverse events will be collected during the intervention period.
13 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Center of Neurology and Psychiatry, Japan

Les enquêteurs

  • Chercheur principal: Norio Watanabe, MD, PhD, Kyoto University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 juin 2014

Achèvement primaire (Réel)

2 mars 2016

Achèvement de l'étude (Réel)

6 septembre 2016

Dates d'inscription aux études

Première soumission

27 mai 2014

Première soumission répondant aux critères de contrôle qualité

27 mai 2014

Première publication (Estimation)

30 mai 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRG-NP-NCNP-25-8

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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