UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023632
Receipt No. 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

* 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 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
Institute National Center of Neurology and Psychiatry
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 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
URL(English) https://upload.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


Contact us.