Anxiety Disorders Clinical Trial
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
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.
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.
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