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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028198
Receipt No. 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

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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
Email 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
Email nsmisato@people.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032274

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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