UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051916 |
|---|---|
| Receipt number | R000059232 |
| Scientific Title | Smartphone cognitive behavioral therapy for preventing relapse in treatment-resistant depression after a successful course of repetitive transcranial magnetic stimulation: An open pilot study |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2025/04/03 12:03:33 |
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Basic information
Public title
Smartphone cognitive behavioral therapy for preventing relapse in treatment-resistant depression after a successful course of repetitive transcranial magnetic stimulation: An open pilot study
Acronym
Smartphone cognitive behavioral therapy for depression after rTMS
Scientific Title
Smartphone cognitive behavioral therapy for preventing relapse in treatment-resistant depression after a successful course of repetitive transcranial magnetic stimulation: An open pilot study
Scientific Title:Acronym
Pilot study on feasibility and acceptability of smartphone cognitive behavioral therapy for depression after rTMS
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Feasibility
Basic objectives2
Others
Basic objectives -Others
Acceptability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of smartphone cognitive behavioral therapy app at 6 weeks
Key secondary outcomes
Change in PHQ-9 at 1, 2, 3, 4, 5, and 6 weeks
Changes in GAD-7, ISI, SWEMWBS, cognitive and behavioral skills, social functioning, and EQ-5D-5L at 3 and 6 weeks
CSQ-3 at 6 weeks
Questionnaire on lesson progress, usage, and burden of the app at 6 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
| Other |
Interventions/Control_1
Smartphone cognitive behavioral therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years of age or older
Patients with diagnosed o major depressive disorder and moderate to severe depressive symptoms who did not respond to an optimal dose of one or more antidepressants for a sufficient period, or who were unable to receive adequate antidepressants due to intolerance
Patients with treatment response (HAMD-17 >50% improvement from baseline) or remission (HAMD-17 <7) after 3-6 weeks of rTMS
Familiarity with smartphone operation
Able to read, write, and communicate in Japanese
Voluntary consent to participate in the study
Key exclusion criteria
Acute suicidal ideation
Cannot read or write Japanese
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Furukawa |
Organization
Kyoto University Graduate School of Medicine/School of Public Health
Division name
Dept of Health Promotion and Human Behavior
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539491
furukawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Matsuda |
Organization
Kyoto University Graduate School of Medicine/School of Public Health
Division name
Dept of Health Promotion and Human Behavior
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539491
Homepage URL
matsuda.yuki.77x@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
81757534680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 15 | 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
3
Results
Among the three participants, two completed the study, while one discontinued in the second week.
Results date posted
| 2025 | Year | 04 | Month | 03 | Day |
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
| 2023 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059232
