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 |
Therapeutic Mechanisms and Neural Substrates of Transdiagnostic Cognitive Behavioral Therapy for Emotional Disorders (Continuation of an Ancillary Study to an Existing Trial)
JUNP MRI study
Therapeutic Mechanisms and Neural Substrates of Transdiagnostic Cognitive Behavioral Therapy for Emotional Disorders (Continuation of an Ancillary Study to an Existing Trial)
JUNP MRI study
Japan |
Anxiety Disorders
Depressive Disorders
Psychiatry |
Others
NO
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.
Others
The present study aims to examine the therapeutic mechanisms and neural substrates that underlie variability in treatment response to the UP.
Exploratory
Explanatory
Phase III
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) [Time Frame: 21 weeks]
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]
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Behavior,custom | Other |
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.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
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.
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.
200
1st name | Masaya |
Middle name | |
Last name | Ito |
National Center of Neurology and Psychiatry
National Center of Cognitive-Behavior Therapy and Research
187-8551
Kodaira, Tokyo, Japan, 187-8551
+81-42-341-2712(3605)
masaya-ito@umin.ac.jp
1st name | Masaya |
Middle name | |
Last name | Ito |
National Center of Neurology and Psychiatry
National Center of Cognitive-Behavior Therapy and Research
187-8551
Kodaira, Tokyo, Japan, 187-8551
+81-42-341-2712(3605)
masaya-ito@umin.ac.jp
National Center of Neurology and Psychiatry, Japan
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
National Center of Neurology and Psychiatry (NCNP)
Japanese Governmental office
Institutional Review Board at National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
+81-42-341-2711
rinri-jimu@ncnp.go.jp
NO
国立精神・神経医療研究センター病院
2025 | Year | 07 | Month | 22 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 05 | Month | 17 | Day |
2023 | Year | 06 | Month | 09 | Day |
2023 | Year | 06 | Month | 09 | Day |
2028 | Year | 03 | Month | 31 | Day |
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.
2025 | Year | 07 | Month | 22 | Day |
2025 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066868