title: 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.
abstract: BACKGROUND
  It is reported that nursing is one of the most vulnerable jobs for developing depression. While they may not be clinically diagnosed as depressed, nurses often suffer from depression and anxiety symptoms, which can lead to a low level of patient care. However, there is no rigorous evidence base for determining an effective prevention strategy for these symptoms in nurses. After reviewing previous literature, we chose a strategy of treatment with omega-3 fatty acids and a mindfulness-based stress management program for this purpose. We aim to explore the effectiveness of these intervention options for junior nurses working in hospital wards in Japan.
  
  
  METHODS
  A factorial-design multi-center randomized trial is currently being conducted. A total of 120 nurses without a managerial position, who work for general hospitals and gave informed consent, have been randomly allocated to a stress management program or psychoeducation using a leaflet, and to omega-3 fatty acids or identical placebo pills. The stress management program has been developed according to mindfulness cognitive therapy and consists of four 30-minute individual sessions conducted using a detailed manual. These sessions are conducted by nurses with a managerial position. Participants allocated to the omega-3 fatty acid groups are provided with 1,200 mg/day of eicosapentaenoic acid and 600 mg/day of docosahexaenoic acid for 90 days. The primary outcome is the change in the total score of the Hospital Anxiety and Depression Scale (HADS), determined by a blinded rater via the telephone at week 26. Secondary outcomes include the change in HADS score at 13 and 52 weeks; presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores and adverse events at 13, 26 and 52 weeks.
  
  
  CONCLUSIONS
  An effective preventive intervention may not only lead to the maintenance of a healthy mental state in nurses, but also to better quality of care for inpatients. This paper outlines the background and methods of a randomized trial that evaluates the possible additive value of omega-3 fatty acids and a mindfulness-based stress management program for reducing depression in nurses.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT02151162 (registered on 27 May 2014).
authors: Department of Clinical Epidemiology, Translational Medical Center, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi, Kodaira, Tokyo, Tokyo 187-8551, Japan. noriow@ncnp.go.jp.
authors: Norio
authors: N
authors: Watanabe
authors: Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan. furukawa@kuhp.kyoto-u.ac.jp.
authors: Toshi A
authors: TA
authors: Furukawa
authors: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi, Kodaira, Tokyo, 187-8551, Japan. mhorikoshi@ncnp.go.jp.
authors: Masaru
authors: M
authors: Horikoshi
authors: Department of Psychiatric and Mental Health Nursing, Nagoya City University School of Nursing, 1 Kawasumi, Mizuho-ku, Nagoya, 467-0001, Japan. katsuki@med.nagoya-cu.ac.jp.
authors: Fujika
authors: F
authors: Katsuki
authors: Department of Clinical Epidemiology, Translational Medical Center, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi, Kodaira, Tokyo, Tokyo 187-8551, Japan. narisawa@ncncp.go.jp.
authors: Tomomi
authors: T
authors: Narisawa
authors: Department of Clinical Research, Translational Medical Center, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi, Kodaira, Tokyo, Japan. kumachim@ncnp.go.jp.
authors: Mie
authors: M
authors: Kumachi
authors: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi, Kodaira, Tokyo, 187-8551, Japan. yukioe@ncnp.go.jp.
authors: Yuki
authors: Y
authors: Oe
authors: National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi, Kodaira, Tokyo, 187-8551, Japan. issei@ncnp.go.jp.
authors: Issei
authors: I
authors: Shinmei
authors: Correspondence Division, Musashino University, 1-1-20 Shinmachi, Nishitokyo, Tokyo, 202-8585, Japan. hnoguchi@musashino-u.ac.jp.
authors: Hiroko
authors: H
authors: Noguchi
authors: Department of Public Health, Faculty of Medicine, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan. keihama@med.u-toyama.ac.jp.
authors: Kei
authors: K
authors: Hamazaki
authors: Department of Clinical Epidemiology, Translational Medical Center, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-higashi, Kodaira, Tokyo, Tokyo 187-8551, Japan. yutaka@ncnp.go.jp.
authors: Yutaka
authors: Y
authors: Matsuoka
mesh_terms: D001007:Anxiety / Q000628:therapy; D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000628:therapy; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D006801:Humans; D064866:Mindfulness; D009726:Nurses / Q000523:psychology*; D017063:Outcome Assessment, Health Care; D018384:Oxidative Stress; D011788:Quality of Life; D013315:Stress, Psychological / Q000523:psychology / Q000628:therapy*
chemical_list: D015525:Fatty Acids, Omega-3
references: Health Promot Int. 2011 Dec;26 Suppl 1:i85-107
references: 22079938
references: Nutrition. 2005 Jun;21(6):705-10
references: 15925295
references: Sleep Med. 2001 Jul;2(4):297-307
references: 11438246
references: Lancet. 1998 Apr 18;351(9110):1213
references: 9643729
references: Rev Saude Publica. 2005 Feb;39(1):1-8
references: 15654454
references: Brain Behav Immun. 2012 Aug;26(6):988-95
references: 22640930
references: Psychol Rep. 2007 Dec;101(3 Pt 1):952-60
references: 18232454
references: Lancet. 2014 May 24;383(9931):1824-30
references: 24581683
references: JAMA. 1999 Nov 10;282(18):1737-44
references: 10568646
references: J Atheroscler Thromb. 2008 Aug;15(4):206-12
references: 18776704
references: Chronobiol Int. 2013 May;30(4):628-36
references: 23445510
references: Am J Clin Nutr. 2011 Feb;93(2):455-62
references: 21159785
references: Am J Cardiol. 2003 Feb 6;91(3A):7A-11A
references: 12645638
references: Mol Psychiatry. 2012 Dec;17(12):1161-3; author reply 1163-7
references: 22824812
references: Am J Nurs. 2012 Feb;112(2):30-8; quiz 48, 39
references: 22261652
references: JAMA Intern Med. 2014 Mar;174(3):357-68
references: 24395196
references: J Behav Med. 1985 Jun;8(2):163-90
references: 3897551
references: Ind Health. 2007 Oct;45(5):622-36
references: 18057805
references: Cochrane Database Syst Rev. 2006;(4):CD002892
references: 17054155
references: Psychosom Med. 2014 Jan;76(1):12-9
references: 24336428
references: JAMA. 2014 Jul 2;312(1):85-6
references: 25058221
references: PLoS One. 2014;9(5):e96905
references: 24805797
references: Mol Psychiatry. 2012 Dec;17(12):1272-82
references: 21931319
references: J Clin Psychiatry. 2011 Dec;72(12):1577-84
references: 21939614
references: Psychol Med. 2014 Jul;44(10):2067-76
references: 24289852
references: Acta Psychiatr Scand. 1983 Jun;67(6):361-70
references: 6880820
references: Int J Ment Health Nurs. 2013 Apr;22(2):180-9
references: 22713110
references: J Am Geriatr Soc. 2007 Sep;55(9):1421-5
references: 17767685
references: Soc Sci Med. 2001 Feb;52(4):499-507
references: 11206648
references: PLoS One. 2014;9(10):e111191
references: 25340520
references: Health Policy. 1990 Dec;16(3):199-208
references: 10109801
references: BMC Public Health. 2012;12:457
references: 22716044
references: Int J Surg. 2012;10(1):28-55
references: 22036893
references: Nurse Educ Today. 2009 Jul;29(5):538-43
references: 19141364
references: Arch Intern Med. 2006 May 22;166(10):1092-7
references: 16717171
references: JAMA. 2009 May 20;301(19):2005-15
references: 19454639
references: J Psychosom Res. 1997 Jan;42(1):17-41
references: 9055211
references: Int Angiol. 1999 Jun;18(2):127-30
references: 10424368
references: J Clin Psychiatry. 2011 Dec;72(12):1651-8
references: 21457679
references: Int J Occup Med Environ Health. 2014 Apr;27(2):252-69
references: 24729300
references: Prostaglandins Leukot Essent Fatty Acids. 2009 Aug-Sep;81(2-3):223-31
references: 19515544
references: Psychiatry Clin Neurosci. 2005 Aug;59(4):441-52
references: 16048450
references: Can J Biochem Physiol. 1959 Aug;37(8):911-7
references: 13671378
references: Br J Psychiatry. 1991 Mar;158:379-86
references: 2036538
references: Appl Nurs Res. 2006 May;19(2):105-9
references: 16728295
references: Biometrics. 1975 Mar;31(1):103-15
references: 1100130
references: Int J Methods Psychiatr Res. 2004;13(2):93-121
references: 15297906
references: Am J Obstet Gynecol. 2013 Apr;208(4):313.e1-9
references: 23531328
references: J Gen Intern Med. 2005 Aug;20(8):738-42
references: 16050884
references: Clin Nurse Spec. 2012 May-Jun;26(3):177-82
references: 22504476
references: Environ Health Prev Med. 2001 Oct;6(3):189-91
references: 21432260
references: Arch Intern Med. 2012 Jan 23;172(2):101-11
references: 22271118
references: Psychother Psychosom. 2012;81(5):315-7
references: 22854784
references: Jpn J Clin Oncol. 1998 May;28(5):333-8
references: 9703862
references: J Occup Environ Med. 2004 Jun;46(6 Suppl):S23-37
references: 15194893
references: J Health Hum Serv Adm. 1999 Spring;21(4):472-89
references: 10621016
references: Cochrane Database Syst Rev. 2006;(3):CD004691
references: 16856055
references: JAMA. 2014 Jul 2;312(1):78-84
references: 25058220
references: Arterioscler Thromb Vasc Biol. 2005 May;25(5):1038-44
references: 15746438
references: J Affect Disord. 2011 Feb;128(3):211-9
references: 20696480
references: Sleep. 2011 May;34(5):601-8
references: 21532953
references: J Nurs Manag. 2001 Mar;9(2):101-6
references: 11879452