Depressive DisorderHNPNCT02151162
Happy Nurse Project: Lifestyle Interventions to Maintain Healthy Mental State in Hospital Nurses
A study testing Mindfulness-based stress management program, Omega-3 fatty acids pills and Psychoeducation leaflet in people with Depressive Disorder and Anxiety Disorders, run by National Center of Neurology and Psychiatry, Japan at 2 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Anxiety Disorders
- What is being tested?
- Mindfulness-based stress management program, Omega-3 fatty acids pills and Psychoeducation leaflet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesJapan
- Study dates
- 11 Jun 2014to 6 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
Kyoto University
Kyoto, 606-8501
About this study
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.
Read the 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.
- Conditions
- Depressive Disorder, Anxiety Disorders
- Being tested
- Mindfulness-based stress management program, Omega-3 fatty acids pills, Psychoeducation leaflet, Placebo pills
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress management programBehavioural
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 pillsDietary supplement
Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.
Psychoeducation leafletBehavioural
Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
Placebo pillsDietary supplement
Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
| Study group | Role | What they receive |
|---|---|---|
| Stress management plus omega-3 | Experimental | Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. Receives: Behavioral: Mindfulness-based stress management program; Dietary Supplement: Omega-3 fatty acids pills |
| Stress management plus placebo | Active comparator | Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. Receives: Behavioral: Mindfulness-based stress management program; Dietary Supplement: Placebo pills |
| Psychoeducation leaflet plus omega-3 | Active comparator | Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. Receives: Dietary Supplement: Omega-3 fatty acids pills; Behavioral: Psychoeducation leaflet |
| Psychoeducation leaflet plus placebo | Active comparator | Thirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. Receives: Behavioral: Psychoeducation leaflet; Dietary Supplement: Placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (26)
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Measured: 13 weeks
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Measured: 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.
Measured: 26 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
Measured: 13 weeks
Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD)
Measured: 52 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Personal Health Questionnaire-9 is a 9-item structured questionnaire to measure depression severity.
Measured: 26 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Measured: 13 weeks
Depression severity: Personal Health Questionnaire-9 (PHQ-9)
Measured: 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.
Measured: 26 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
Measured: 13 weeks
Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7)
Measured: 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.
Measured: 26 weeks
Insomnia severity: Insomnia Severity Index (ISI)
Measured: 13 weeks
Insomnia severity: Insomnia Severity Index (ISI)
Measured: 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.
Measured: 26 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
Measured: 13 weeks
Somatic symptoms: The Bradford Somatic Inventory (BSI)
Measured: 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).
Measured: 26 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
Measured: 13 weeks
Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ)
Measured: 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.
Measured: 26 weeks
Burnout: Maslach Burnout Inventory (MBI)
Measured: 13 weeks
Burnout: Maslach Burnout Inventory (MBI)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start11 Jun 2014
- Primary completion2 Mar 2016
- Study completion6 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center of Neurology and Psychiatry, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norio Watanabe, MD, PhD, Principal investigator, Kyoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151162
- Sponsor's protocol ID
- IRG-NP-NCNP-25-8
- Acronym
- HNP
- Status last verified
- Aug 2018
- First submitted
- 27 May 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
PubMed 32627860Watanabe N, Horikoshi M, Shinmei I, Oe Y, Narisawa T, Kumachi M, Matsuoka Y, Hamazaki K, Furukawa TA. Brief mindfulness-based stress management program for a better mental state in working populations - Happy Nurse Project: A randomized controlled trial✰✰. J Affect Disord. 2019 May 15;251:186-194. doi: 10.1016/j.jad.2019.03.067. Epub 2019 Mar 22.
PubMed 30927579Watanabe N, Furukawa TA, Horikoshi M, Katsuki F, Narisawa T, Kumachi M, Oe Y, Shinmei I, Noguchi H, Hamazaki K, Matsuoka Y. A mindfulness-based stress management program and treatment with omega-3 fatty acids to maintain a healthy mental state in hospital nurses (Happy Nurse Project): study protocol for a randomized controlled trial. Trials. 2015 Jan 31;16:36. doi: 10.1186/s13063-015-0554-z.
PubMed 25636180
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02151162
- Acronym / sponsor ID
- HNP / IRG-NP-NCNP-25-8
- Conditions
- Depressive Disorder, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Center of Neurology and Psychiatry, JapanUniversity, hospital or other
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 2 Mar 2016 (actual)
- Study completion
- 6 Sep 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stress management plus omega-3 | Experimental | Behavioral: Mindfulness-based stress management program, Dietary Supplement: Omega-3 fatty acids pillsThirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. |
| Stress management plus placebo | Active comparator | Behavioral: Mindfulness-based stress management program, Dietary Supplement: Placebo pillsThirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. |
| Psychoeducation leaflet plus omega-3 | Active comparator | Dietary Supplement: Omega-3 fatty acids pills, Behavioral: Psychoeducation leafletThirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. |
| Psychoeducation leaflet plus placebo | Active comparator | Behavioral: Psychoeducation leaflet, Dietary Supplement: Placebo pillsThirty participants will be allocated to the arm. These interventions will terminate until 3 months from registration for each participant. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress management programMindfulness-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. | Behavioural | Stress management plus omega-3, Stress management plus placebo |
| Omega-3 fatty acids pillsOmega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day. | Dietary supplement | Psychoeducation leaflet plus omega-3, Stress management plus omega-3 |
| Psychoeducation leafletPsychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health. | Behavioural | Psychoeducation leaflet plus omega-3, Psychoeducation leaflet plus placebo |
| Placebo pillsPlacebo pills will include rapeseed oil, soybean oil, olive oil and fish oil. | Dietary supplement | Psychoeducation leaflet plus placebo, Stress management plus placebo |
Primary outcome
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS)
Time frame: 26 weeks
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 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: 26 weeks
Quality of Life: EuroQol (EQ-5D)
Time frame: 13 weeks
Quality of Life: EuroQol (EQ-5D)
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 32627860Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
- Derived from this study: PubMed 30927579Watanabe N, Horikoshi M, Shinmei I, Oe Y, Narisawa T, Kumachi M, Matsuoka Y, Hamazaki K, Furukawa TA. Brief mindfulness-based stress management program for a better mental state in working populations - Happy Nurse Project: A randomized controlled trial✰✰. J Affect Disord. 2019 May 15;251:186-194. doi: 10.1016/j.jad.2019.03.067. Epub 2019 Mar 22.
- Derived from this study: PubMed 25636180Watanabe N, Furukawa TA, Horikoshi M, Katsuki F, Narisawa T, Kumachi M, Oe Y, Shinmei I, Noguchi H, Hamazaki K, Matsuoka Y. A mindfulness-based stress management program and treatment with omega-3 fatty acids to maintain a healthy mental state in hospital nurses (Happy Nurse Project): study protocol for a randomized controlled trial. Trials. 2015 Jan 31;16:36. doi: 10.1186/s13063-015-0554-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norio Watanabe, MD, PhD principal investigator
Kyoto University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress management program, Omega-3 fatty acids pills and Psychoeducation leaflet in people with Depressive Disorder and Anxiety Disorders, run by National Center of Neurology and Psychiatry, Japan at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02151162, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.