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NCT Number: NCT06517121

tDCS 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Education University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Nichol ML Wong, PhD

CONTACT

[email protected]

852-29487431

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Changes in self-reported loneliness

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

    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.

Secondary outcomes

  1. Changes in depressive symptoms

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

    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

  2. Changes in anxiety symptoms

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

    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

  3. Changes in self-reported mood

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

    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).

  4. Changes in brain activation and connectivity

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

    Neural activities and connectivity in Ventral Attention Network, Frontoparietal Network, and Default Mode Network are assessed by functional MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Nichol ML Wong, PhD

CONTACT

[email protected]

852-29487431

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • Chinese University of Hong Kong
  • Hong Kong Baptist University
  • The University of Hong Kong

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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