UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023632
Receipt number R000027209
Scientific Title Feasibility study of group unified protocol psychotherapy for patients with depressive and anxiety disorders
Date of disclosure of the study information 2016/08/17
Last modified on 2019/02/21 17:23:25

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Basic information

Public title

Feasibility study of group unified protocol psychotherapy for patients with depressive and anxiety disorders

Acronym

Pilot study of group unified protocol for anxiety and depression (GUPPY Study)

Scientific Title

Feasibility study of group unified protocol psychotherapy for patients with depressive and anxiety disorders

Scientific Title:Acronym

Pilot study of group unified protocol for anxiety and depression (GUPPY Study)

Region

Japan


Condition

Condition

Unipolar mood disorders, Anxiety disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the feasibility of the group format of the unified protocol for adult patients with unipolar mood and/or anxiety disorders.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

1. The Clinical Global Impressions Scale-Severity(CGI-S)
2. Objective severity of depressive symptoms(GRID-HAMD)

Key secondary outcomes

1. The Clinical Global Impressions Scale- Improvement(CGI-I)
2. Subjective severity of Anxiety and impairment(OASIS)
3. Subjective severity of Depression and impairment(ODSIS)
4. Quality of life(EQ-5D-5L)
5. Function(SDISS/GAF)
6. Emotion Regulation(ERSQ)
7. Neuroticism(EPQR-S)
8. Subjective symptoms for primary diagnosis
9. Drop Out rate
10. Adverse Event


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Group cognitive behavioral therapy (Unified Protocol)

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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Subjects with current DSM-IV Panic disorder with/without Agoraphobia, Agoraphobia without history of Panic Disorder, Specific Phobia, Social Phobia (Social Anxiety Disorder), Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, Generalized Anxiety Disorder, Major Depressive Disorder, Dysthymic disorder
2. The Clinical Global Impressions Scale-Severity of illness >= 4
3. Age 20 years or older, and 65 years or younger at screening
4. Subjects who give full consent in the participation of the study

Key exclusion criteria

1. No alcohol or substance use disorder in a year prior to the baseline
2. No manic episode or psychotic disorders at baseline
3. No serious suicidal ideation at baseline (GRID-HAMD Item 3 symptom intensity is less than moderate)
4. Evidence of unable to participate half or more of the intervention phase
5. No structured psychotherapy (except supportive therapy) during the intervention
6. No major cognitive deficits or No life-threatening, severe or unstable physical disorders at baseline
7. Other relevant reason decided by the investigators

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaru Horikoshi Ph.D.

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code


Address

Ogawahigashi4-1-1, Kodaira-shi, Tokyo, Japan

TEL

042-341-2711

Email

mhorikoshi@ncnp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriko Kato

Organization

National Center of Neurology and Psychiatry

Division name

National Center for Cognitive Behavior Therapy and Research

Zip code


Address

Ogawahigashi4-1-1, Kodaira-shi, Tokyo, Japan

TEL

042-341-2711

Homepage URL


Email

norikokato@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

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

Keio University School of Medicine
Nishimura clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

国立精神・神経医療研究センター(東京都)
慶應義塾大学医学部(東京都)
にしむらクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 17 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

2016 Year 06 Month 06 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2018 Year 12 Month 01 Day

Date analysis concluded

2019 Year 01 Month 10 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 15 Day

Last modified on

2019 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027209


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name