UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060204 |
|---|---|
| Receipt number | R000068858 |
| Scientific Title | A Study on the Effects and Efficacy of Brainspotting Psychotherapy for Cancer Patients and Patients with Depression |
| Date of disclosure of the study information | 2025/12/26 |
| Last modified on | 2025/12/25 15:33:30 |
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Basic information
Public title
A Study on the Effects and Efficacy of Brainspotting Psychotherapy for Cancer Patients and Patients with Depression
Acronym
Research on the Effects and Efficacy of Brainspotting
Scientific Title
A Study on the Effects and Efficacy of Brainspotting Psychotherapy for Cancer Patients and Patients with Depression
Scientific Title:Acronym
Research on the Effects and Efficacy of Brainspotting
Region
| Japan |
Condition
Condition
Cancer,Depression
Classification by specialty
| Hematology and clinical oncology | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Regarding the psychological distress experienced by cancer patients, including anxiety and depression, this study views it as encompassing the pathology of traumatic experiences. It aims to verify the efficacy of Brainspotting, a recently developed psychotherapy addressing traumatic memories, to maintain and enhance the mental health and improve the quality of life (QOL) of cancer patients and those presenting with depression or depressive states. Concurrently, we will analyze fluctuations in various psychological and biological factors correlated with these effects, attempting to establish psychological and biological indicators substantiating its efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic Nervous System Function (ANS) and Heart Rate Variability (HRV)
Key secondary outcomes
BDI-II (Beck Depression Inventory-II)
STAI (State and Trait Anxiety Inventory)
Japanese Version BPQ-BA (Body Perception Questionnaire-Body Awareness)
BRS (Bidimensional Resilience Scale)
FACT-G (Functional Assessment of Cancer Therapy-General) Japanese Version
Baum Test
Self-Esteem Scale
Loneliness Scale
alpha-MSH (Pituitary Melanocyte-Stimulating Hormone)
Cortisol (Adrenal Corticosteroid Hormone)
Melatonin (Pineal Hormone)
Orexin A (Hypothalamic Hormone)
Oxytocin (Hypothalamic Hormone)
Substance P (Central and Peripheral Nerve Peptide)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cancer Patient
Interventions/Control_2
Depression Patient
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
(1) Patients aged 18 years or older, regardless of gender
(2) Individuals experiencing anxiety, depression, or other mental health difficulties related to cancer or mood disorders, who are willing and able to attend outpatient treatment aimed at symptom improvement
(3) Individuals who understand the purpose and procedures of this study and who provide written informed consent to participate voluntarily
Key exclusion criteria
Those deemed inappropriate by the attending physician's judgment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MAI |
| Middle name | |
| Last name | KAWAMURA |
Organization
Sapporo Medical University
Division name
Ain Nitori Department of Palliative Medicine and Supportive Care
Zip code
0608543
Address
Sapporo City, Chuo Ward, Minami 1-jo Nishi 16-chome
TEL
0116112111
myoneta@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | MAI |
| Middle name | |
| Last name | KA |
Organization
Sapporo Medical University
Division name
Ain Nitori Department of Palliative Medicine and Supportive Care
Zip code
0608543
Address
Sapporo City, Chuo Ward, Minami 1-jo Nishi 16-chome
TEL
0116112111
Homepage URL
myoneta@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical 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
Sapporo Medical University
Address
Sapporo City, Chuo Ward, Minami 1-jo Nishi 16-chome
Tel
0116112111
myoneta@sapmed.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
| 2025 | Year | 12 | Month | 26 | 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 | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | 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 | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068858
