tDCS in People With Subthreshold Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized Experimental Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS), Conventional Experimental Transcranial Direct Current Stimulation (tDCS).
- Who it may be relevant to
- Registry conditions: Subthreshold Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People With Subthreshold Depression
Overview
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Changes in depressive symptoms [Time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session]
- Changes in anxiety symptoms [Time frame: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session]
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Education University of Hong Kong — Hong Kong
Identifiers
NCT: NCT06517121 · 2023-2024-0048