UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013270 |
|---|---|
| Receipt number | 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 11:37:38 |
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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
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
noriow@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015476
