UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059046 |
|---|---|
| Receipt number | R000067531 |
| Scientific Title | Evaluation of the efficacy of smartphone-based cognitive behavioral therapy for preventing relapse in treatment-resistant depression after a successful course of repetitive transcranial magnetic stimulation: a randomized controlled trial |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/09/10 15:42:39 |
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Basic information
Public title
Evaluation of the efficacy of smartphone-based cognitive behavioral therapy for preventing relapse in treatment-resistant depression after a successful course of repetitive transcranial magnetic stimulation: a randomized controlled trial
Acronym
smartphone-based cognitive behavioral therapy for depression after rTMS: a randomized controlled trial
Scientific Title
Evaluation of the efficacy of smartphone-based cognitive behavioral therapy for preventing relapse in treatment-resistant depression after a successful course of repetitive transcranial magnetic stimulation: a randomized controlled trial
Scientific Title:Acronym
A randomized controlled trial of smartphone-based cognitive behavioral therapy for preventing relapse of depression after rTMS
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether combined therapy with smartphone-based cognitive behavioral therapy (sCBT) and pharmacotherapy is more effective than pharmacotherapy alone in preventing relapse among adult patients with moderate-to-severe depression, characterized by non-response to antidepressant pharmacotherapy and subsequent response or remission with acute-phase rTMS therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse-free survival up to 26 weeks from study initiation
Key secondary outcomes
Change from baseline in PHQ-9 GAD-7 and EQ-5D-5L scores
Incidence of major depressive episodes as assessed by CIDI
Occurrence of PHQ9 total score greater than or equal to 10 with endorsement of item 9 (Thoughts that you would be better off dead or of hurting yourself in some way) at level 2 (more than half the days) or level 3 (nearly every day) on two consecutive assessments
Hospitalization and death
Adverse events spontaneously reported by study participants
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Combination of smartphone-based cognitive behavioral therapy and pharmacotherapy
Interventions/Control_2
pharmacotherapy alone
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have provided written informed consent after receiving sufficient explanation about the study and fully understanding it, based on their own free will
Adult patients (aged 18 years or older) with depression who did not achieve the expected therapeutic effect despite adequate pharmacotherapy with existing antidepressants and were judged to be eligible for rTMS therapy
Patients who, after 3 to 6 weeks of rTMS therapy, demonstrated response, defined as a reduction of 50% or more in HAMD-17 total score from baseline, or remission, defined as a HAMD-17 total score of 7 or lower, and with a PHQ-9 score of less than 10
Patients capable of verbal and written communication in Japanese
Patients who own a smartphone and are familiar with its operation
Key exclusion criteria
Patients with suicidal ideation
Patients with a history of schizophrenia, schizoaffective disorder, or bipolar disorder, as clinically diagnosed by the attending physician
Patients with a current diagnosis of dementia, eating disorder, substance dependence, or borderline personality disorder, as clinically diagnosed by the attending physician
Patients judged by the investigators to have difficulty using the smartphone application
Any other patients deemed inappropriate for participation by the principal investigator or co-investigators
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Matsuda |
Organization
Fujita Health University School of Medicine
Division name
Department of Development and Education of Clinical Research
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-2000
myuki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Matsuda |
Organization
Fujita Health University School of Medicine
Division name
Department of Development and Education of Clinical Research
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-2000
Homepage URL
myuki@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Fujita Health University Medical Research Ethics Committee
Address
1-98, Dengaku-kubo, Kutsukake-cho, Toyoake City, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.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
藤田医科大学病院(愛知県)、東京慈恵会医科大学附属病院（東京都）、国立精神・神経医療研究センター病院（東京都）、大阪医科薬科大学病院（大阪府）、関西医科大学総合医療センター（大阪府）、浅香山病院（大阪府）、神奈川県立精神医療センター（神奈川県）、和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | 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
Management information
Registered date
| 2025 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067531
