Subthreshold DepressionNCT06517121
tDCS in People With Subthreshold Depression
A study testing Personalized Experimental Transcranial Direct Current Stimulation (tDCS) and Conventional Experimental Transcranial Direct Current Stimulation (tDCS) in people with Subthreshold Depression, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subthreshold Depression
- What is being tested?
- Personalized Experimental Transcranial Direct Current Stimulation (tDCS) and Conventional Experimental Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Jan 2026to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
- At least primary school education
- Subthreshold depression
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Education University of Hong Kong
Hong Kong
Nichol ML Wong, PhD, 852-29487431, nmlwong@eduhk.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Subthreshold Depression
- Being tested
- Personalized Experimental Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS), Conventional Experimental Transcranial Direct Current Stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalised tDCS group | Experimental | Participants who are assigned to the personalised group will receive anodal tDCS over a individualized stimulation site. Receives: 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. Receives: 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. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: 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).
Measured: 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
Measured: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start16 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subthreshold DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Chinese University of Hong Kong, Hong Kong Baptist University
- Responsible party
- Principal investigator, WONG Man Lok Nichol, Education University of Hong Kong
- Investigators
- Nichol ML Wong, PhD, Principal investigator, Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517121
- Sponsor's protocol ID
- 2023-2024-0048
- Status last verified
- Jan 2026
- First submitted
- 11 Jul 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No