Happy Nurse Project: Lifestyle Interventions to Maintain Healthy Mental State in Hospital Nurses
Condition: Depressive Disorder; Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness-based stress management program; Omega-3 fatty acids pills; Psychoeducation leaflet; Placebo pills
Intervention type(s): Behavioral; Dietary Supplement; Behavioral; Dietary Supplement
Intervention description(s): 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.; Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.; Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention