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

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ClinicalTrials.gov Identifier: NCT02151162
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
National Center of Neurology and Psychiatry, Japan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Depressive Disorder Anxiety Disorders Behavioral: Mindfulness-based stress management program Dietary Supplement: Omega-3 fatty acids pills Behavioral: Psychoeducation leaflet Dietary Supplement: Placebo pills Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 11, 2014
Actual Primary Completion Date : March 2, 2016
Actual Study Completion Date : September 6, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Dietary Supplement: 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.

Active Comparator: Stress management plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
Behavioral: 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.

Dietary Supplement: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.

Active Comparator: 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.
Dietary Supplement: 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.

Behavioral: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

Active Comparator: Psychoeducation leaflet plus placebo
Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.
Behavioral: Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

Dietary Supplement: Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.




Primary Outcome Measures :
  1. Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 13 weeks ]
  2. Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 52 weeks ]
  3. Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD) [ Time Frame: 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.

  4. Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD) [ Time Frame: 13 weeks ]
  5. Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD) [ Time Frame: 52 weeks ]
  6. Depression severity: Personal Health Questionnaire-9 (PHQ-9) [ Time Frame: 26 weeks ]
    Personal Health Questionnaire-9 is a 9-item structured questionnaire to measure depression severity.

  7. Depression severity: Personal Health Questionnaire-9 (PHQ-9) [ Time Frame: 13 weeks ]
  8. Depression severity: Personal Health Questionnaire-9 (PHQ-9) [ Time Frame: 52 weeks ]
  9. Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7) [ Time Frame: 26 weeks ]
    The GAD-7 consists of 7 items, and the total score ranges from 0 to 21.

  10. Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7) [ Time Frame: 13 weeks ]
  11. Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7) [ Time Frame: 52 weeks ]
  12. Insomnia severity: Insomnia Severity Index (ISI) [ Time Frame: 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.

  13. Insomnia severity: Insomnia Severity Index (ISI) [ Time Frame: 13 weeks ]
  14. Insomnia severity: Insomnia Severity Index (ISI) [ Time Frame: 52 weeks ]
  15. Somatic symptoms: The Bradford Somatic Inventory (BSI) [ Time Frame: 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.

  16. Somatic symptoms: The Bradford Somatic Inventory (BSI) [ Time Frame: 13 weeks ]
  17. Somatic symptoms: The Bradford Somatic Inventory (BSI) [ Time Frame: 52 weeks ]
  18. Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ) [ Time Frame: 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).

  19. Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ) [ Time Frame: 13 weeks ]
  20. Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ) [ Time Frame: 52 weeks ]
  21. Burnout: Maslach Burnout Inventory (MBI) [ Time Frame: 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.

  22. Burnout: Maslach Burnout Inventory (MBI) [ Time Frame: 13 weeks ]
  23. Burnout: Maslach Burnout Inventory (MBI) [ Time Frame: 52 weeks ]
  24. Quality of Life: EuroQol (EQ-5D) [ Time Frame: 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.

  25. Quality of Life: EuroQol (EQ-5D) [ Time Frame: 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.

  26. Quality of Life: EuroQol (EQ-5D) [ Time Frame: 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.


Other Outcome Measures:
  1. Adverse events [ Time Frame: 13 weeks ]
    Information about any possible adverse events will be collected during the intervention period.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151162


Locations
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Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Kyoto University
Kyoto, Japan, 606-8501
Sponsors and Collaborators
National Center of Neurology and Psychiatry, Japan
Investigators
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Principal Investigator: Norio Watanabe, MD, PhD Kyoto University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Center of Neurology and Psychiatry, Japan
ClinicalTrials.gov Identifier: NCT02151162     History of Changes
Other Study ID Numbers: IRG-NP-NCNP-25-8
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Anxiety Disorders
Pathologic Processes
Mood Disorders
Mental Disorders