tDCS in People With Subthreshold Depression

Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People With Subthreshold Depression

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

Study Overview

• Status: Recruiting
• Conditions: Subthreshold Depression
• Intervention / Treatment: Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS); Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)

Detailed Description

Depression-prone individuals will be invited and allocated to three groups, either the personalised transcranial direct current stimulation (tDCS) group, the conventional tDCS group, or the sham control group. After screening and at baseline prior to the tDCS sessions, participants will complete tests and questionnaires on depression symptoms, loneliness and mood. Eligible participants will also be invited to receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a maximum of 10 sessions to be completed after the screening and baseline measures. For both personalised tDCS group and the conventional tDCS group, tDCS with 2 milliampere (mA) intensity will be delivered for 20 minutes in each session. For sham control group, the protocol will be similar, except that the stimulation only happens in the first 30 seconds in each session. Especially for participants allocated to the personalised tDCS group, the stimulation site for each individual in this group may vary, depending on their brain activations and connectivity. The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC. Immediately after and also 3-months after completing all the tDCS sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood. Eligible participants will also be invited to receive functional MRI scanning in the 3T MRI scanner again. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nichol ML Wong, PhD; Phone Number: 852-29487431; Email: nmlwong@eduhk.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Education University of Hong Kong
    • Contact: Nichol ML Wong, PhD; Phone Number: 852-29487431; Email: nmlwong@eduhk.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional tDCS group; Participants who are assigned to the Conventional group will receive anodal tDCS over F3.	Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS); 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.
Sham Comparator: Sham control group; 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); 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.
Experimental: Personalised tDCS group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in depressive symptoms	Depressive symptoms are assessed based on the Hospital Anxiety and Depression Scale, a 14-item scale assessing severity of depressive and anxiety symptom (score range 0 - 21 for both subscale), with a higher scores indicating higher severity	From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in anxiety symptoms	Anxiety symptoms are assessed based on the Hospital Anxiety and Depression Scale, a 14-item scale assessing severity of depressive and anxiety symptom (score range 0 - 21 for both subscale), with a higher scores indicating higher severity	From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in self-reported mood	Mood is assessed based on the Chinese Affect Scale, a 20-item 5-point Likert scale where participants rate the degree to which they currently feel the listed affects (scoring for each item: 0 = no at all; 4 = very).	From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Changes in brain activation and connectivity	Neural activities and connectivity in Ventral Attention Network, Frontoparietal Network, and Default Mode Network are assessed by functional MRI	From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session

Collaborators and Investigators

• Sponsor: Education University of Hong Kong
• Collaborators: The University of Hong Kong; Chinese University of Hong Kong; Hong Kong Baptist University
• Investigators: Principal Investigator: Nichol ML Wong, PhD, Education University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2023-2024-0048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No