UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019946
Receipt number R000023033
Scientific Title Clinical and economical evaluation of Nurse-led Cognitive Behavioral Group Therapy for Recovery of Self-esteem
Date of disclosure of the study information 2015/11/30
Last modified on 2020/12/25 16:39:33

* 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

Clinical and economical evaluation of Nurse-led Cognitive Behavioral Group Therapy for Recovery of Self-esteem

Acronym

Clinical and economical evaluation of Nurse-led CBGT for Self-esteem

Scientific Title

Clinical and economical evaluation of Nurse-led Cognitive Behavioral Group Therapy for Recovery of Self-esteem

Scientific Title:Acronym

Clinical and economical evaluation of Nurse-led CBGT for Self-esteem

Region

Japan


Condition

Condition

Mental disorder listed in the DMS-5

Classification by specialty

Psychiatry Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine clinical and economic effectiveness of Nurse-led Cognitive Behavioral Group Therapy for patients with mental disorders living in the community, in Japanese clinical settings

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Rosenberg Self-esteem Scale
(evaluation: beseline, half-intervention, post-intervention, 3-month follow-up)

Key secondary outcomes

Cognitive Bias Scale
Profile of Mood States
EQ-5D-5L Japanese version
The Global Assessment of Functioning
Unit price per 1 hour for intervention(nurse)
Necessary expenses & time to join in the program for participants


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Cognitive Behavioral Therapy in addition to usual care (December 2015-December 2018, 12sessions, 1/week, 2hours/1 session)

Interventions/Control_2

Usual care only

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

Mental disorder by the DMS-5, Outpatient with mental disorder (DSM-5) living community who have no seriously psychiatric symptoms

Key exclusion criteria

Mental retardation, major neurocognitive disorder, antisocial personality disorder, other severe mental/physical condition

Target sample size

51


Research contact person

Name of lead principal investigator

1st name Hiroko
Middle name
Last name Kunikata

Organization

Kagawa Prefectural University of Health Sciences

Division name

Faculty of Health Sciences, Department of Nursing

Zip code

761-0123

Address

281-1 Murecho-hara, Takamatsu, Kagawa, Japan

TEL

087-870-1243

Email

kunikata@chs.pref.kagawa.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Kunikata

Organization

Kagawa Prefectural University of Health Sciences

Division name

Faculty of Health Sciences, Department of Nursing

Zip code

761-0123

Address

281-1 Murecho-hara, Takamatsu, Kagawa, Japan

TEL

087-870-1243

Homepage URL


Email

kunikata@chs.pref.kagawa.jp


Sponsor or person

Institute

Mental Health & Psychiatric Nursing, Kagawa Prefectural University of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

Grants-in Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Organization for Promotion of Tenure Track, University of Miyazaki

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagawa Prefectural University of Health Sciences

Address

Murecho-hara, Takamatsu, Kagawa

Tel

087-870-1378

Email

kunikata@chs.pref.kagawa.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

いわき病院(香川県)Iwaki Hospital(Kagawa)
古新町こころの診療所(香川県)Furushinnmati Mental Clinic


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

DOI: 10.1111/jjns.12371

Number of participants that the trial has enrolled

51

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 06 Month 02 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 12 Month 01 Day

Date of IRB

2015 Year 07 Month 22 Day

Anticipated trial start date

2015 Year 12 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 27 Day

Last modified on

2020 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023033


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name