Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

20. august 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 59 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Kosttilskudd: 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.
Aktiv komparator: Stress management plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
Atferdsmessig: 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.
Kosttilskudd: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Aktiv komparator: 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.
Kosttilskudd: 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.
Atferdsmessig: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
Aktiv komparator: Psychoeducation leaflet plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
Kosttilskudd: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Atferdsmessig: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adverse events
Tidsramme: 13 weeks
Information about any possible adverse events will be collected during the intervention period.
13 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Center of Neurology and Psychiatry, Japan

Etterforskere

  • Hovedetterforsker: Norio Watanabe, MD, PhD, Kyoto University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. juni 2014

Primær fullføring (Faktiske)

2. mars 2016

Studiet fullført (Faktiske)

6. september 2016

Datoer for studieregistrering

Først innsendt

27. mai 2014

Først innsendt som oppfylte QC-kriteriene

27. mai 2014

Først lagt ut (Anslag)

30. mai 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRG-NP-NCNP-25-8

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere