UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060595 |
|---|---|
| Receipt number | R000069309 |
| Scientific Title | Preliminary Examination of the Efficacy and Group Processes of Group Cognitive Behavioral Therapy Based on the Unified Protocol Delivered by Certified Public Psychologists, Nurses, and Other Mental Health Professionals Under the Direction of Psychiatrists |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/05 23:44:10 |
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Basic information
Public title
A Preliminary Study on the Efficacy of the Group Cognitive Behavioral Therapy Based on the Unified Protocol
Acronym
GRO-UP Study
Scientific Title
Preliminary Examination of the Efficacy and Group Processes of Group Cognitive Behavioral Therapy Based on the Unified Protocol Delivered by Certified Public Psychologists, Nurses, and Other Mental Health Professionals Under the Direction of Psychiatrists
Scientific Title:Acronym
GRO-UP Study
Region
| Japan |
Condition
Condition
Major Depressive Disorder, Persistent Depressive Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to examine the feasibility and efficacy of the group-based Unified Protocol (UP) among patients with major depressive disorder, persistent depressive disorder, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, and generalized anxiety disorder as defined in DSM-5.
Additionally, interviews will be conducted with study participants to explore group CBT processes in Japan, focusing on the content of a measure assessing group cohesion and their experiences with group CBT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Feasibility: dropout rates, intervention satisfaction (CSQ-8), adverse events
Efficacy: clinical global impression-severity (CGI-S)
Key secondary outcomes
1. Assessment of Diagnosed Mental Disorders (DIAMOND)
2. Clinical global impression-improvement (CGI-I)
3. Objective severity of depressive symptoms (GRID-HAMD)
4. Subjective severity of depressive symptoms (PHQ-9, ODSIS)
5. Subjective severity of anxiety symptoms (GAD-7, OASIS)
6. Transdiagnostic dimensions of emotional disorders (MEDI)
7. Social functioning (WSAS)
8. Quality of Life (EuroQol)
9. Subjective change of positive emotions (PES)
10. Subjective change of other emotions (OES)
11. Group alliance (GSRS)
12. Working alliance (J-WAI-SR)
13. Group cohesion (GCS)
14. Adherence to Homework (HCS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Group Cognitive Behavioral Therapy Based on the 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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who meet the DSM-5 diagnostic criteria at the pre-intervention assessment for one of the following: major depressive disorder, persistent depressive disorder, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder
2) Moderate or greater symptom severity (Clinical Global Impressions-Severity of Illness: CGI-S >= 4) is present at the pre-intervention assessment, as assessed by the CGI-S
3) Age between 18 and 70 years
4) Individuals who are deemed by the treating psychiatrist to be suitable for CBT
5) Individuals who provided written informed consent after understanding the purpose and procedures of the study and agreeing to participate voluntarily
Key exclusion criteria
1) Individuals with alcohol use disorder or substance use disorder at the pre-intervention assessment
2) Individuals with hypomanic episodes, manic episodes, or psychotic disorders at the pre-intervention assessment
3) Individuals who exhibit marked suicidal ideation (rated as severe on the Suicide module of the GRID-HAMD) at the pre-intervention assessment
4) Individuals who are known in advance to have difficulty attending six or more sessions during the intervention period
5) Individuals who are receiving other structured psychotherapies (excluding supportive therapy and psychoeducation) during the intervention period
6) Individuals who, at the pre-intervention assessment, have physical illnesses or severe cognitive impairment to a degree that would make it difficult to carry out the group-based UP
7) Individuals deemed unsuitable for participation in this study by the principal investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Ito |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
TEL
042-341-2711
masayait@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kato |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
TEL
042-341-2711
Homepage URL
norikokato@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Musashino University
Japan Depression Center Rokubancho mental clinic
Rikkyo University
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
Tel
042-341-2711
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
国立精神・神経医療研究センター病院
日本うつ病センター 六番町メンタルクリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069309
