Happy Nurse Project: Lifestyle Interventions to Maintain Healthy Mental State in Hospital Nurses

Anxiety Disorders Clinical Trial

— HNP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151162
• Other study ID #: IRG-NP-NCNP-25-8
• Status: Completed
• Phase: N/A
• Start date: June 11, 2014
• Est. completion date: September 6, 2016

Study information

• Verified date: August 2018
• Source: National Center of Neurology and Psychiatry, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Disease

Intervention

Behavioral:
• Mindfulness-based stress management program
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.

Dietary Supplement:
• Omega-3 fatty acids pills
Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.

Behavioral:
• Psychoeducation leaflet
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.

Dietary Supplement:
• Placebo pills
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.

Locations

Country	Name	City	State
Japan	National Center of Neurology and Psychiatry	Kodaira	Tokyo
Japan	Kyoto University	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
National Center of Neurology and Psychiatry, Japan

Country where clinical trial is conducted

Japan, 

Outcome

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