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

Information source: National Center of Neurology and Psychiatry, Japan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder; Anxiety Disorders

Intervention: Mindfulness-based stress management program (Behavioral); Omega-3 fatty acids pills (Dietary Supplement); Psychoeducation leaflet (Behavioral); Placebo pills (Dietary Supplement)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Center of Neurology and Psychiatry, Japan

Official(s) and/or principal investigator(s):
Norio Watanabe, MD, PhD, Principal Investigator, Affiliation: National Center of Neurology and Psychiatry

Overall contact:
Norio Watanabe, MD, PhD, Phone: +81-42-341-2711, Ext: 7841, Email: noriow@ncnp.go.jp

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)

Secondary outcome:

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

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

Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)

Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)

Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)

Depression severity: Personal Health Questionnaire-9 (PHQ-9)

Depression severity: Personal Health Questionnaire-9 (PHQ-9)

Depression severity: Personal Health Questionnaire-9 (PHQ-9)

Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)

Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)

Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)

Insomnia severity: Insomnia Severity Index (ISI)

Insomnia severity: Insomnia Severity Index (ISI)

Insomnia severity: Insomnia Severity Index (ISI)

Somatic symptoms: The Bradford Somatic Inventory (BSI)

Somatic symptoms: The Bradford Somatic Inventory (BSI)

Somatic symptoms: The Bradford Somatic Inventory (BSI)

Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)

Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)

Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)

Burnout: Maslach Burnout Inventory (MBI)

Burnout: Maslach Burnout Inventory (MBI)

Burnout: Maslach Burnout Inventory (MBI)

Quality of Life: EuroQol (EQ-5D)

Quality of Life: EuroQol (EQ-5D)

Quality of Life: EuroQol (EQ-5D)

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.

Eligibility

Minimum age: 20 Years. Maximum age: 59 Years. Gender(s): Female.

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

Locations and Contacts

Norio Watanabe, MD, PhD, Phone: +81-42-341-2711, Ext: 7841, Email: noriow@ncnp.go.jp

National Center of Neurology and Psychiatry, Kodaira, Tokyo 187-8551, Japan; Recruiting
Tomomi Narisawa, BA, Email: narisawa@ncnp.go.jp
Additional Information

Starting date: June 2014
Last updated: June 18, 2014

Page last updated: August 23, 2015

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