UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013270
Receipt No. R000015476
Scientific Title Stress-management-program intervention to alleviate psychological distress in ward nurses: Pilot study
Date of disclosure of the study information 2014/02/26
Last modified on 2014/05/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Stress-management-program intervention to alleviate psychological distress in ward nurses: Pilot study
Acronym Intervention to alleviate psychological distress in ward nurses
Scientific Title Stress-management-program intervention to alleviate psychological distress in ward nurses: Pilot study
Scientific Title:Acronym Intervention to alleviate psychological distress in ward nurses
Region
Japan

Condition
Condition Mood or anxiety disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study will aim to examine the feasibility of stress-management program, that is developed to alleviate psychological distress in ward nurses, by administrating the program to a small number of nurses. The study will also aim to obtain pilot data for calculation of sample sizes in the future trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese version of the Hospital Anxiety and Depression Scale (HADS)
Key secondary outcomes PHQ9: Patient Health Questionnaire
GAD-7: Generalized anxiety disorder - 7-item anxiety scale
HPQ: World Health Organization Heath and Work Performance Questionnaire
ISI: Insomnia severity index
MBI: Maslach Burnout Inventory

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Stress-management program, that is developed based on cognitive behavioral therapy and mindfulness cognitive therapy. The program consists of four 30-minute sessions, conducted weekly. Trained senior nurses will perform the program to junior nurses.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria 1) Working as a full-time ward nurse for National Center of Neurology and Psychiatry, Japan.
2) Below the threshold of clinical depression, that is defined by satisfying both the HADS-D total score no less than 10 and a negative in PRIME-MD for screening major depressive episode according to DSM-IV.
3) Below the threshold of clinical anxiety disorders, that is defined by satisfying the HADS-A total score no less than 10.
4) Providing an informed consent to participate the study.
Key exclusion criteria 1) Having a plan to retire or suspend from her job within 3 months at entry to the study.
2) Having structured psychotherapy at entry to the study.
3) Classified ineligible by a study personnel for any reasons.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Watanabe
Organization National Center of Neurology and Psychiatry, Japan
Division name Translational Medical Center
Zip code
Address 4-1-1 Ogawa-higashi, Kodaira, Tokyo, Japan
TEL 042-341-2711
Email noriow@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Watanabe
Organization National Center of Neurology and Psychiatry, Japan
Division name Translational Medical Center
Zip code
Address 4-1-1 Ogawa-higashi, Kodaira, Tokyo, Japan
TEL 042-341-2711
Homepage URL
Email noriow@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry, Japan
Institute
Department

Funding Source
Organization National Center of Neurology and Psychiatry, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 03 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2014 Year 04 Month 30 Day
Date analysis concluded
2014 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2014 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015476

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.