UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058549
Receipt number R000066868
Scientific Title Therapeutic Mechanisms and Neural Substrates of Transdiagnostic Cognitive Behavioral Therapy for Emotional Disorders (Continuation of an Ancillary Study to an Existing Trial)
Date of disclosure of the study information 2025/07/22
Last modified on 2025/07/22 15:46:40

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Basic information

Public title

Therapeutic Mechanisms and Neural Substrates of Transdiagnostic Cognitive Behavioral Therapy for Emotional Disorders (Continuation of an Ancillary Study to an Existing Trial)

Acronym

JUNP MRI study

Scientific Title

Therapeutic Mechanisms and Neural Substrates of Transdiagnostic Cognitive Behavioral Therapy for Emotional Disorders (Continuation of an Ancillary Study to an Existing Trial)

Scientific Title:Acronym

JUNP MRI study

Region

Japan


Condition

Condition

Anxiety Disorders
Depressive Disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In the primary outcome paper, the hypothesis was supported that a combination of cognitive behavioral therapy (CBT) and treatment as usual (TAU) was more effective than a waitlist condition for CBT alongside TAU in reducing depressive and anxiety symptoms, as measured by the GRID-HAMD, in patients with depressive and anxiety disorders (Ito et al., 2023). However, the average change in GRID-HAMD scores following the Unified Protocol (UP) was approximately five points, and some patients showed no clear improvement. These findings suggest that the UP is not universally effective for all patients within its target population. Therefore, the present study aims to examine the therapeutic mechanisms and neural substrates that underlie variability in treatment response.

Basic objectives2

Others

Basic objectives -Others

The present study aims to examine the therapeutic mechanisms and neural substrates that underlie variability in treatment response to the UP.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) [Time Frame: 21 weeks]

Key secondary outcomes

Assessment of Therapeutic Mechanisms and Processes
(Patient-Reported Questionnaires for Therapeutic Mechanisms)
Neuroticism (EPQR-S) [Time Frame: 21 weeks]
Anxiety Sensitivity (ASI) [ Time Frame: 21 weeks]
Emotion Regulation Skills (ERSQ) [Time Frame: 21 weeks]
Emotional Exposure Scale (EES) [Time Frame: 21 weeks]
Therapeutic Principles of the Unified Protocol (TRUP) [Time Frame: 21 weeks]
(Process Measures)
Credibility/Expectancy Questionnaire (CEQ) : Rated by both therapist and patient [Time Frame: 21 weeks]
Session Rating Scale (SRS) : Rated by both therapist and patient [Time Frame: 21 weeks]
Homework Compliance Scale (HCS) : Rated by therapist [Time Frame: 21 weeks]
Therapist Adherence Scale (TAS) : Rated by supervisors and independent raters [Time Frame: 21 weeks]
Neuroimaging Data
3-Tesla MRI: Resting-state fMRI and T1-weighted 3D structural images [Time Frame: 21 weeks]


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 Other

Interventions/Control_1

Unified Protocol with Treatment As Usual
Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual.

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

a) DSM-IV or DSM-5 diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID or M.I.N.I..
b) Depressive and anxiety symptoms is mild or more severe (GRID-HAMD >= 8).
c) Ages 20 years or older, and 65 years or younger at screening.
d) Subjects who give full consent in the participation of the study.

Key exclusion criteria

a) No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID or M.I.N.I..
b) No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID or M.I.N.I..
c) No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.)
d) No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline.
e) Evidence of unable to participate half or more of the intervention phase.
f) No structured psychotherapy during at baseline.
g) Other relevant reason decided by the investigators.

Target sample size

200


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 of Cognitive-Behavior Therapy and Research

Zip code

187-8551

Address

Kodaira, Tokyo, Japan, 187-8551

TEL

+81-42-341-2712(3605)

Email

masaya-ito@umin.ac.jp


Public contact

Name of contact person

1st name Masaya
Middle name
Last name Ito

Organization

National Center of Neurology and Psychiatry

Division name

National Center of Cognitive-Behavior Therapy and Research

Zip code

187-8551

Address

Kodaira, Tokyo, Japan, 187-8551

TEL

+81-42-341-2712(3605)

Homepage URL


Email

masaya-ito@umin.ac.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry, Japan

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology (MEXT)
National Center of Neurology and Psychiatry (NCNP)

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

Institutional Review Board at National Center of Neurology and Psychiatry

Address

Kodaira, Tokyo, Japan, 187-8551

Tel

+81-42-341-2711

Email

rinri-jimu@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


Other administrative information

Date of disclosure of the study information

2025 Year 07 Month 22 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

2023 Year 05 Month 17 Day

Date of IRB

2023 Year 06 Month 09 Day

Anticipated trial start date

2023 Year 06 Month 09 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study has been disclosed and conducted as "Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders" (UMIN Number: UMIN000030708), and this registration succeeds the ancillary research part of the clinical trial.


Management information

Registered date

2025 Year 07 Month 22 Day

Last modified on

2025 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066868