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Focused Mindfulness Walking and at-home tDCS: An Exploratory Study

Safety and Efficacy of Mindfulness Walking With Transcranial Direct Current Stimulation in a Home Environment for Mild Depression and Adjustment Disorders: A Exploratory Study - CEED-3 study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052260033
Enrollment
5
Registered
2026-04-28
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild depression or adjustment disorder Depression, adjustment disorder, mindfulness, tDCS,

Interventions

FMW-tDCS (Mindfulness: Focused Mindfulness Walking [FMW]) and tDCS (Transcranial Direct Current Stimulation [tDCS]) simultaneously

Sponsors

Nishida Keiichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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

Contacts

Public ContactKeiichiro Nishida

Osaka Medical and Pharmaceutical University Hospital

knishida@ompu.ac.jp+81-72-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026