UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028198 |
|---|---|
| Receipt number | R000032274 |
| Scientific Title | Effectiveness of an individual supportive nursing approach for spouses of patients with depression. |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/08/21 08:42:51 |
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Basic information
Public title
Effectiveness of an individual supportive nursing approach for spouses of patients with depression.
Acronym
Effectiveness of an individual supportive nursing approach for spouses of patients with depression.
Scientific Title
Effectiveness of an individual supportive nursing approach for spouses of patients with depression.
Scientific Title:Acronym
Effectiveness of an individual supportive nursing approach for spouses of patients with depression.
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the effectiveness of a supportive nursing approach among spouses of patients with depression and its influence on the mood states of depressed patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
The total score of RSES after 8 weeks from the baseline survey.
Key secondary outcomes
HAM-D(Hamilton Rating Scale for Depression)
PHQ-9(Patient Health Questionnaire-9)
MSPSS(Multidimensional Scale of Perceived Social Support)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: the participants will undergo an intervention utilizing the individual approach, consisting of four sessions within 2-4 months.
Interventions/Control_2
Wait-list control group: the participants will undergo an intervention from 2 months after baseline.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(Patients)
･Patients who meet any of the criteria for Bipolar Disorder (Current Episode Depressed), Major Depressive Disorder (Single Episode, Recurrent Episode) or Persistent Depressive Disorder (Dysthymia) according to the ICD-10.
･Patients who have been known his/her own diagnosis.
･Patients who can obtain permission from their doctor to participate in the study.
･Patients who can answer the questionnaire.
(Spouses)
･Spouses who range in age from 20-75 years.
･Spouses who are in a marital relationship or de facto marriage.
･Spouses who live with the patient.
･Spouses who can converse in Japanese language.
･Spouses who can answer the questionnaire.
Key exclusion criteria
(Patients)
･Patients who are at imminent risk of suicide at baseline.
(Spouses)
･Spouses who take into the family support program (e.g., family psychoeducation, family peer group).
･Spouses who are undergoing psychological treatment (e.g., psychological counselling).
･Spouses who are undergoing medical treatment for a severe mental disorder.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Misato |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
6540142
Address
7-10-2 Tomogaoka Suma-ku, Kobe-city 654-0142 Hyogo Japan
TEL
078-796-4580
nsmisato@people.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Misato |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
6540142
Address
7-10-2 Tomogaoka Suma-ku, Kobe-city 654-0142 Hyogo Japan
TEL
078-796-4580
Homepage URL
nsmisato@people.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences
Address
7-10-2 Tomogaoka Suma-ku, Kobe-city 654-0142 Hyogo Japan
Tel
078-796-4502
syomu2@ams.kobe-u.ac.jp
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
| 2017 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032274
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| Registered date | File name |
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| Registered date | File name |
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