Anxiety Disorders Clinical Trial
— HNPOfficial 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
Verified date | August 2018 |
Source | National Center of Neurology and Psychiatry, Japan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 6, 2016 |
Est. primary completion date | March 2, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 59 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Japan | National Center of Neurology and Psychiatry | Kodaira | Tokyo |
Japan | Kyoto University | Kyoto |
Lead Sponsor | Collaborator |
---|---|
National Center of Neurology and Psychiatry, Japan |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Information about any possible adverse events will be collected during the intervention period. | 13 weeks | |
Primary | 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 | Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) | 13 weeks | ||
Secondary | Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) | 52 weeks | ||
Secondary | 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. | 26 weeks | |
Secondary | Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD) | 13 weeks | ||
Secondary | Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD) | 52 weeks | ||
Secondary | Depression severity: Personal Health Questionnaire-9 (PHQ-9) | Personal Health Questionnaire-9 is a 9-item structured questionnaire to measure depression severity. | 26 weeks | |
Secondary | Depression severity: Personal Health Questionnaire-9 (PHQ-9) | 13 weeks | ||
Secondary | Depression severity: Personal Health Questionnaire-9 (PHQ-9) | 52 weeks | ||
Secondary | Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7) | The GAD-7 consists of 7 items, and the total score ranges from 0 to 21. | 26 weeks | |
Secondary | Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7) | 13 weeks | ||
Secondary | Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7) | 52 weeks | ||
Secondary | 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. | 26 weeks | |
Secondary | Insomnia severity: Insomnia Severity Index (ISI) | 13 weeks | ||
Secondary | Insomnia severity: Insomnia Severity Index (ISI) | 52 weeks | ||
Secondary | 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. | 26 weeks | |
Secondary | Somatic symptoms: The Bradford Somatic Inventory (BSI) | 13 weeks | ||
Secondary | Somatic symptoms: The Bradford Somatic Inventory (BSI) | 52 weeks | ||
Secondary | 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). | 26 weeks | |
Secondary | Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ) | 13 weeks | ||
Secondary | Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ) | 52 weeks | ||
Secondary | 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. | 26 weeks | |
Secondary | Burnout: Maslach Burnout Inventory (MBI) | 13 weeks | ||
Secondary | Burnout: Maslach Burnout Inventory (MBI) | 52 weeks | ||
Secondary | 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. | 26 weeks | |
Secondary | 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. | 13 weeks | |
Secondary | 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. | 52 weeks |
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