NCT06517121

Brief Summary

This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

July 11, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

July 11, 2024

Last Update Submit

January 29, 2026

Conditions

Subthreshold Depression

Outcome Measures

Primary Outcomes (1)

  • Changes in self-reported loneliness

    Loneliness is assessed based on the University of California, Los Angeles (UCLA) loneliness scale and single item, in which higher scores indicate greater degrees of loneliness.

    From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session

Secondary Outcomes (4)

  • Changes in depressive symptoms

    From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session

  • Changes in anxiety symptoms

    From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session

  • Changes in self-reported mood

    From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session

  • Changes in brain activation and connectivity

    From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session

Study Arms (3)

Personalised tDCS group

EXPERIMENTAL

Participants who are assigned to the personalised group will receive anodal tDCS over a individualized stimulation site.

Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS)

Conventional tDCS group

EXPERIMENTAL

Participants who are assigned to the Conventional group will receive anodal tDCS over F3.

Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS)

Sham control group

SHAM COMPARATOR

Participants who are assigned to the Conventional group will receive sham tDCS. The active stimulation will be delivered for the first 30 seconds only.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Interventions

Personalized Experimental Transcranial Direct Current Stimulation (tDCS)DEVICE

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing.

Personalised tDCS group
Sham Transcranial Direct Current Stimulation (tDCS)DEVICE

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation.

Sham control group
Conventional Experimental Transcranial Direct Current Stimulation (tDCS)DEVICE

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3.

Conventional tDCS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
  • At least primary school education
  • Subthreshold depression

You may not qualify if:

  • On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Nichol ML Wong, PhD

    Education University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nichol ML Wong, PhD

CONTACT

852-29487431nmlwong@eduhk.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 24, 2024

Study Start

January 16, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)