UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040864
Receipt number R000046451
Scientific Title Positive valence system-focused cognitive behavioral therapy using virtual reality on depression: A feasibility study
Date of disclosure of the study information 2020/06/23
Last modified on 2022/01/12 14:57:32

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Basic information

Public title

Positive valence system-focused cognitive behavioral therapy using virtual reality on depression: A feasibility study

Acronym

PoCot-VR

Scientific Title

Positive valence system-focused cognitive behavioral therapy using virtual reality on depression: A feasibility study

Scientific Title:Acronym

PoCot-VR

Region

Japan


Condition

Condition

Major Depressive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine the feasibility of cognitive behavioral therapy using virtual reality technology on patients with depression

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Beck Depression Inventory-II (BDI-II) at week 12

Key secondary outcomes

Japanese version of the Snaith-Hamilton Pleasure Scale (SHAPS) at week 12
Anhedonia sub-scale of BDI-II at week 12


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Other

Interventions/Control_1

Positive valanced system-focused cognitive behavioral therapy treats anhedonia and is delivered for 60 minutes once a week, eight times during 11 weeks. Patients will use virtual reality technology to experience positive emotions. Online sessions will be allowed under certain conditions.

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

18 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Having at least mild symptoms of depression (Scoring 11 or higher on BDI-II)
2. Between 18 and 64 years old

Key exclusion criteria

(a) Current psychotic disorders at baseline assessed by the Mini-International Neuropsychiatric Interview (MINI)
(b) Current manic episodes at baseline assessed by MINI
(c) Currently severe substance use disorders at baseline assessed by MINI
(d) Serious suicidal ideation at baseline assessed by MINI
(e) Medical devices that impair the functionality of the VR device (a pacemaker, hearing aid, defibrillator, implantable medical devices, etc.)
(f) No permission from the doctor to use the VR device
(g) Other problems that become significant obstacles when administering cognitive behavior therapy and implementing the VR deice

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Masaya, Masaru
Middle name
Last name Ito, Horikoshi

Organization

National Center Hospital of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code

187-8551

Address

Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN

TEL

+81-42-341-2711

Email

masaya-ito@umin.ac.jp


Public contact

Name of contact person

1st name Toshitaka
Middle name
Last name Hamamura

Organization

National Center Hospital of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code

187-8551

Address

Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN

TEL

+81-42-341-2711

Homepage URL


Email

toshitaka-hamamura@umin.ac.jp


Sponsor or person

Institute

National Center for Cognitive Behavior Therapy and Research, National Center Hospital of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

JOLLY GOOD Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

JOLLY GOOD Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board at National Center Hospital of Neurology and Psychiatry

Address

Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN, 187-8551

Tel

+81-42-341-2711

Email

ml_rinrijimu@ncnp.go.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

2020 Year 06 Month 23 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

2020 Year 05 Month 26 Day

Date of IRB

2020 Year 02 Month 07 Day

Anticipated trial start date

2020 Year 06 Month 24 Day

Last follow-up date

2023 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 06 Month 23 Day

Last modified on

2022 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046451


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name