An interventional study of Mindfulness-based stress management program and Omega-3 fatty acids pills in Depressive Disorder and Anxiety Disorders, sponsored by National Center of Neurology and Psychiatry, Japan. Completed at 2 sites in Japan. Open to female participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by National Center of Neurology and Psychiatry, Japan · Not applicable, Interventional, and Prevention
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →National Center of Neurology and Psychiatry, Japan is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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.
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.
Time frame: 26 weeks
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Time frame: 13 weeks
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Time frame: 52 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
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.
Time frame: 26 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
Time frame: 13 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
Time frame: 52 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Personal Health Questionnaire-9 is a 9-item structured questionnaire to measure depression severity.
Time frame: 26 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Time frame: 13 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Time frame: 52 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 consists of 7 items, and the total score ranges from 0 to 21.
Time frame: 26 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 13 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 52 weeks
Insomnia severity: Insomnia Severity Index (ISI)
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.
Time frame: 26 weeks
Insomnia severity: Insomnia Severity Index (ISI)
Time frame: 13 weeks
Insomnia severity: Insomnia Severity Index (ISI)
Time frame: 52 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
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.
Time frame: 26 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
Time frame: 13 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
Time frame: 52 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
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).
Time frame: 26 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
Time frame: 13 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
Time frame: 52 weeks
Burnout: Maslach Burnout Inventory (MBI)
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.
Time frame: 26 weeks
Burnout: Maslach Burnout Inventory (MBI)
Time frame: 13 weeks
Burnout: Maslach Burnout Inventory (MBI)
Time frame: 52 weeks
Quality of Life: EuroQol (EQ-5D)
EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments.
Time frame: 26 weeks
Quality of Life: EuroQol (EQ-5D)
EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments.
Time frame: 13 weeks
Quality of Life: EuroQol (EQ-5D)
EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments.
Time frame: 52 weeks
Adverse events
Information about any possible adverse events will be collected during the intervention period.
Time frame: 13 weeks
Plan to share: Undecided
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National Center of Neurology and Psychiatry, Japan