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

NCT02151162 | Completed DMC

• 1 other identifier: IRG-NP-NCNP-25-8
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Disorder; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (26)

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

  13 weeks

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

  52 weeks

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

  26 weeks

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

  13 weeks

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

  52 weeks

Other Outcomes (1)

• Adverse events

  13 weeks

Study Arms (4)

Stress management plus omega-3

EXPERIMENTAL

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; Dietary Supplement: Omega-3 fatty acids pills

Stress management plus placebo

ACTIVE COMPARATOR

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; Dietary Supplement: Placebo pills

Psychoeducation leaflet plus omega-3

ACTIVE COMPARATOR

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; Behavioral: Psychoeducation leaflet

Psychoeducation leaflet plus placebo

ACTIVE COMPARATOR

Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant.

Behavioral: Psychoeducation leaflet; Dietary Supplement: Placebo pills

Interventions

Mindfulness-based stress management program BEHAVIORAL

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.

Stress management plus omega-3; Stress management plus placebo

Omega-3 fatty acids pills DIETARY_SUPPLEMENT

Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.

Psychoeducation leaflet plus omega-3; Stress management plus omega-3

Psychoeducation leaflet BEHAVIORAL

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

Psychoeducation leaflet plus omega-3; Psychoeducation leaflet plus placebo

Placebo pills DIETARY_SUPPLEMENT

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

Psychoeducation leaflet plus placebo; Stress management plus placebo

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center of Neurology and Psychiatry, Japan: lead

Study Sites (2)

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

Location

Kyoto University

Kyoto, 606-8501, Japan

Location

Related Publications (3)

• 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.

  PMID: 32627860 DERIVED

• 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.

  PMID: 30927579 DERIVED

• 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.

  PMID: 25636180 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Norio Watanabe, MD, PhD

  Kyoto University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: June 11, 2014
• Primary Completion: March 2, 2016
• Study Completion: September 6, 2016
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

JP (2)