- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151162
Happy Nurse Project: Lifestyle Interventions to Maintain Healthy Mental State in Hospital Nurses (HNP)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kyoto, Japan, 606-8501
- Kyoto University
-
-
Tokyo
-
Kodaira, Tokyo, Japan, 187-8551
- National Center of Neurology and Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
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.
|
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.
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.
|
Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.
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.
|
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Time Frame: 13 weeks
|
13 weeks
|
|
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Time Frame: 52 weeks
|
52 weeks
|
|
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.
|
26 weeks
|
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
Time Frame: 13 weeks
|
13 weeks
|
|
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
Time Frame: 52 weeks
|
52 weeks
|
|
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.
|
26 weeks
|
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Time Frame: 13 weeks
|
13 weeks
|
|
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Time Frame: 52 weeks
|
52 weeks
|
|
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.
|
26 weeks
|
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
Time Frame: 13 weeks
|
13 weeks
|
|
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
Time Frame: 52 weeks
|
52 weeks
|
|
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.
|
26 weeks
|
Insomnia severity: Insomnia Severity Index (ISI)
Time Frame: 13 weeks
|
13 weeks
|
|
Insomnia severity: Insomnia Severity Index (ISI)
Time Frame: 52 weeks
|
52 weeks
|
|
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.
|
26 weeks
|
Somatic symptoms: The Bradford Somatic Inventory (BSI)
Time Frame: 13 weeks
|
13 weeks
|
|
Somatic symptoms: The Bradford Somatic Inventory (BSI)
Time Frame: 52 weeks
|
52 weeks
|
|
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).
|
26 weeks
|
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
Time Frame: 13 weeks
|
13 weeks
|
|
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
Time Frame: 52 weeks
|
52 weeks
|
|
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.
|
26 weeks
|
Burnout: Maslach Burnout Inventory (MBI)
Time Frame: 13 weeks
|
13 weeks
|
|
Burnout: Maslach Burnout Inventory (MBI)
Time Frame: 52 weeks
|
52 weeks
|
|
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.
|
26 weeks
|
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.
|
13 weeks
|
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.
|
52 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 13 weeks
|
Information about any possible adverse events will be collected during the intervention period.
|
13 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Norio Watanabe, MD, PhD, Kyoto University
Publications and helpful links
General Publications
- Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
- Watanabe N, Horikoshi M, Shinmei I, Oe Y, Narisawa T, Kumachi M, Matsuoka Y, Hamazaki K, Furukawa TA. Brief mindfulness-based stress management program for a better mental state in working populations - Happy Nurse Project: A randomized controlled trial✰✰. J Affect Disord. 2019 May 15;251:186-194. doi: 10.1016/j.jad.2019.03.067. Epub 2019 Mar 22.
- Watanabe N, Furukawa TA, Horikoshi M, Katsuki F, Narisawa T, Kumachi M, Oe Y, Shinmei I, Noguchi H, Hamazaki K, Matsuoka Y. A mindfulness-based stress management program and treatment with omega-3 fatty acids to maintain a healthy mental state in hospital nurses (Happy Nurse Project): study protocol for a randomized controlled trial. Trials. 2015 Jan 31;16:36. doi: 10.1186/s13063-015-0554-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRG-NP-NCNP-25-8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Disorder
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedDepressive Disorder, Major Depressive DisorderUnited States
-
Samsung Medical CenterUnknownMajor Depressive Disorder, Anxiety DisorderKorea, Republic of
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
Clinical Trials on Mindfulness-based stress management program
-
VA Office of Research and DevelopmentCompleted
-
Massachusetts General HospitalNational Center for Complementary and Integrative Health (NCCIH)CompletedGeneralized Anxiety DisorderUnited States
-
Milton S. Hershey Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Georgetown... and other collaboratorsRecruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1 | StressUnited States
-
Johns Hopkins UniversityUniversity of Maryland; National Center for Complementary and Integrative Health...Completed
-
Atatürk UniversityCompleted
-
Necmettin Erbakan UniversityActive, not recruitingDEPRESSION | ANXIETY | STRESS | HOPELESSNESS | MİNDFULNESSTurkey
-
Ankara UniversityCompletedBreast Cancer | Nursing CariesTurkey
-
University of Maryland, BaltimoreCompletedChild Abuse SurvivorsUnited States
-
Vanderbilt University Medical CenterCompletedDepression | Stress | Burnout | Anxiety | Self-compassionUnited States
-
Mersin UniversityNot yet recruiting