UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042718
Receipt number R000048758
Scientific Title Effectiveness of Group Supervision in Nurse-Administered Cognitive Behavioral Therapy
Date of disclosure of the study information 2021/01/31
Last modified on 2022/06/13 09:13:41

* 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

Effectiveness of Group Supervision in Nurse-Administered Cognitive Behavioral Therapy

Acronym

Effectiveness of Group Supervision in Nurse-Administered Cognitive Behavioral Therapy

Scientific Title

Effectiveness of Group Supervision in Nurse-Administered Cognitive Behavioral Therapy

Scientific Title:Acronym

Effectiveness of Group Supervision in Nurse-Administered Cognitive Behavioral Therapy

Region

Japan


Condition

Condition

Nurses

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we introduced Group Supervision as a part of CBT training for nurses and examined its effectiveness for improving the nurses' basic knowledge and skills on CBT and their problem-solving ability towards patients in a randomized control trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Problem Solving Scale for Nurses

Key secondary outcomes

1.Cognitive Therapy Awareness Scale
2.General Self-Efficacy Scale
3.Cognitive Therapy Rating Scale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Group Supervision

Interventions/Control_2

no intervention

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Experience of Psychiatric Nurse:more than 3 yeras
2.Full-time work
3.Those who can obtain written consent

Key exclusion criteria

Those who have experience receiving individual or group supervisions

Target sample size

90


Research contact person

Name of lead principal investigator

1st name YOSHIE
Middle name
Last name OKADA

Organization

INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE

Division name

School of Nursing at Narita

Zip code

2868686

Address

4-3 Kozunomori, Narita City

TEL

0476-20-7723

Email

yoshiok@iuhw.ac.jp


Public contact

Name of contact person

1st name YOSHIE
Middle name
Last name OKADA

Organization

INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE

Division name

School of Nursing at Narita

Zip code

2868686

Address

4-3 Kozunomori, Narita City

TEL

0476-20-7723

Homepage URL


Email

yoshiok@iuhw.ac.jp


Sponsor or person

Institute

INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE IRB

Address

2600-1 Kitakanemaru, Ohtawara City

Tel

0287-24-3729

Email

s-rinri@iuhw.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

2021 Year 01 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

24

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

Open public recruiting

Date of protocol fixation

2017 Year 06 Month 30 Day

Date of IRB

2017 Year 07 Month 21 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 10 Day

Last modified on

2022 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name