UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050370 |
|---|---|
| Receipt number | R000057352 |
| Scientific Title | Web-based patient survey on current status of goal setting and relationships between objective evaluable goal setting and patients' perceptions in treatment of depression |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2025/04/21 13:44:28 |
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Basic information
Public title
Web-based patient survey on current status of goal setting and relationships between objective evaluable goal setting and patients' perceptions in treatment of depression
Acronym
Web-based patient survey on current status of goal setting and relationships between objective evaluable goal setting and patients' perceptions in treatment of depression
Scientific Title
Web-based patient survey on current status of goal setting and relationships between objective evaluable goal setting and patients' perceptions in treatment of depression
Scientific Title:Acronym
Web-based patient survey on current status of goal setting and relationships between objective evaluable goal setting and patients' perceptions in treatment of depression
Region
| Japan |
Condition
Condition
Major depressive disorder (MDD)
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the current status of goal setting in the treatment of depression by examining the following: (1) How many patients set goals in the treatment of depression? (2) To what extent can the goals set in the treatment of depression objectively assessable? (3) Does objectively assessable goal setting affect patients' perceptions and awareness in depression treatment?
Basic objectives2
Others
Basic objectives -Others
Data base research with Web-based questionnaire
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Goal setting in depression treatment or not
Key secondary outcomes
'- SMARTness of the established goals
- Correlation between SMART level of the goal or each SMART factor and the trust relationship with the physician, subjective evaluation of the goal, and satisfaction with the treatment.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
- Self-reported with at least 2 hospital visits related to MDD in the past year
- 18 years of age or older
Key exclusion criteria
- Suicide attempts: top 2 choices ("more than half of the time", "almost every day") on a 4-point scale for item (I) of the PHQ-9
- Those who can understand Japanese
- Those with no MDD practice codes (ICD10 codes: F32-F33) in claims data from February 1, 2022 to August 31, 2022.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3278-2111
miwa.izutsu@takeda.com
Public contact
Name of contact person
| 1st name | Fumie |
| Middle name | |
| Last name | Tokuda |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3278-2111
Homepage URL
fumie.tokuda@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Lundbeck Japan K.K.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.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 | 03 | Month | 07 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000057352
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC11921671/
Number of participants that the trial has enrolled
466
Results
This study investigated the impact of communication with physicians regarding goal setting on treatment perceptions among 466 patients with MDD. 70.0% of the patients reported discussing treatment goals with their physicians, and the TRUST score (70.0) and treatment satisfaction score (5.0) in this group were significantly higher than those of patients who did not engage in such communication.
Results date posted
| 2025 | Year | 04 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 20 | Day |
Baseline Characteristics
Patients had a mean (standard deviation) age of 47.3 (9.7) years and the majority (69.5%) were male (Table 1). Most (87.1%) were working or studying, either full- or part-time. The median (range) time between diagnosis of MDD and survey participation was 47.0 months (2-334 months, 27.8 years). For 71.7% of patients, this was their first-episode occurrence of MDD, and 98.7% had visited a psychiatrist or psychosomatic medicine clinic. Treatment with antidepressants was reported by 83.0% of patients, of whom 82.4% (319/387) had received monotherapy and 17.6% (68/387) had received combination or multi-drug treatments. Use of nonpharmacological treatment, either stand-alone or in conjunction with antidepressants, was reported by 20.4% of patients. The median (Q1, Q3) PHQ-9 score at the time of questionnaire response was 8.0 (3.0, 12.0), indicating a relatively mild severity of depression.
Participant flow
Of the 795,670 people aged 18 and older registered with the PHR service, 55,100 responded to the survey, of whom 727 self-reported having received treatment for depression in the past year (March 2022-February 2023). The analysis population included 466 patients, after excluding two patients who could not give consent for the secondary use of their claims data, 194 patients whose MDD medical records could not be obtained from the receipt data, and 65 patients who reported a previous suicide attempt(s)
Adverse events
Not Applicable
Outcome measures
- Communication with physician: Patients reported whether they discussed treatment plans, prognosis, or goals with their physician during depression treatment, including specific symptoms and lifestyle goals.
- Patient Health Questionnaire (J-PHQ-9): The PHQ-9, validated in Japan, scores depression severity (0-27); higher scores reflect more severe depression.
- Trust Scale (TRUST): The Japanese 5-item TRUST scale (0-100) measured trust in physicians, with higher scores indicating stronger trust.
- SMART-goal score: Goals were evaluated against SMART criteria (specific, measurable, attainable, realistic, time-bound) via a 7-point scale, with total scores ranging from 5-35.
- Treatment satisfaction: Patients rated treatment satisfaction on a 7-point scale; higher scores indicated greater satisfaction.
- Patient perceptions: Participants rated the importance of goal-setting discussions with their doctor and gave reasons for recommending this approach.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057352
