JRCT ID: jRCTs052260033
Registered date:28/04/2026
Focused Mindfulness Walking and at-home tDCS: An Exploratory Study
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Mild depression or adjustment disorder |
| Date of first enrollment | 28/04/2026 |
| Target sample size | 5 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | FMW-tDCS (Mindfulness: Focused Mindfulness Walking [FMW]) and tDCS (Transcranial Direct Current Stimulation [tDCS]) simultaneously |
Outcome(s)
| Primary Outcome | To confirm the occurrence of adverse effects (including headache, skin discomfort, tinnitus, fatigue, anxiety, and manic symptoms) and to identify potential challenges in the home application of FMW-tDCS. |
|---|---|
| Secondary Outcome | - the occurrence of adverse reactions and identify any difficulties in performing FMW-tDCS at home. - Adjustment Disorder New Module 20 (ADNM-20) - State Trait Anxiety Inventory (STAI) - Five Facet Mindfulness Questionnaire (FFMQ) - Perceived Stress Scale (PSS) - Work Productivity and Activity Impairment Questionnaire (WPAI) - Quick Inventory of Depressive Symptomatology (QIDS-J) - Social Adaptation Self-evaluation Scale (SASS-J) - Young Mania Rating Scale (YMRS) - Hamilton Depression Rating Scale 17 - Goal Attainment Scale for Depression (GAS-D) - Edinburgh Handeadness Invebntory - THINC-it - EEG - Interview - Number of steps / Heart rate |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 65age old |
| Gender | Both |
| Include criteria | - Individuals aged 18 years or older and younger than 65 years. - Both male and female participants are eligible. - At the beginning of the screening period, patients who are diagnosed as either mild depression or adjustment disorder, without suicidal ideation, and who are receiving outpatient treatment (with a Hamilton Depression Rating Scale [HAMD-17] score of 5 to 16) - Right-handed individuals (to minimize the influence of inter-individual differences in the dominant hemisphere, confirmed by the Edinburgh Handedness Inventory). - Individuals who, after receiving sufficient explanation regarding participation in this study, have fully understood the information and have provided written informed consent of their own free will. |
| Exclude criteria | 1. Individuals with metal implants (excluding titanium) in the brain or skin. 2. Individuals with metal devices (e.g., pacemakers) implanted in the body. 3. Individuals with a history of head surgery or other surgical procedures. 4. Individuals who have experienced head trauma or impaired consciousness due to head trauma. 5. Individuals with skin conditions or disorders in the area of stimulation. 6. Individuals with a history of epileptic seizures. 7. Individuals with a history of syncope (fainting). 8. Individuals who are pregnant or possibly pregnant. 9. Individuals with a history of stroke or other central nervous system disorders. 10. Individuals with a history of psychiatric disorders, such as schizophrenia, bipolar disorder, or substance abuse. 11. Individuals deemed unsuitable as research subjects by the principal investigator. |
Related Information
| Primary Sponsor | Nishida Keiichiro |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | , |
Contact
| Public contact | |
| Name | Keiichiro Nishida |
| Address | 2-7 Daigaku-machi, Takatsuki, Osaka, Japan Osaka Japan 569-8686 |
| Telephone | +81-72-683-1221 |
| knishida@ompu.ac.jp | |
| Affiliation | Osaka Medical and Pharmaceutical University Hospital |
| Scientific contact | |
| Name | Keiichiro Nishida |
| Address | 2-7, daigaku-machi, Takatsuki-city, Osaka Osaka Japan 569-8686 |
| Telephone | +81-726831221 |
| knishida@ompu.ac.jp | |
| Affiliation | Osaka Medical and Pharmaceutical University Hospital |