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

20 sierpnia 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 59 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Suplement diety: 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.
Aktywny 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.
Behawioralne: 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.
Suplement diety: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Aktywny 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.
Suplement diety: 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.
Behawioralne: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
Aktywny 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.
Suplement diety: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Behawioralne: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Ramy czasowe: 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

Miary wyników drugorzędnych

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Adverse events
Ramy czasowe: 13 weeks
Information about any possible adverse events will be collected during the intervention period.
13 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Center of Neurology and Psychiatry, Japan

Śledczy

  • Główny śledczy: Norio Watanabe, MD, PhD, Kyoto University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

11 czerwca 2014

Zakończenie podstawowe (Rzeczywisty)

2 marca 2016

Ukończenie studiów (Rzeczywisty)

6 września 2016

Daty rejestracji na studia

Pierwszy przesłany

27 maja 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 maja 2014

Pierwszy wysłany (Oszacować)

30 maja 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 sierpnia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 sierpnia 2018

Ostatnia weryfikacja

1 sierpnia 2018

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRG-NP-NCNP-25-8

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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