The Effect of Transcranial Direct Current Stimulation (tDCS) in Improving Emotion Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorThe University of Hong Kong
About this trial
The goal of this clinical trial is to investigate how transcranial direct current stimulation (tDCS) affects emotion functions in young adults aged 18-35 from the local community, including both male and female participants. The main question\[s\] it aims to answer are:
* Does tDCS improve emotional functions, such as mood regulation and motivation, in individuals with subthreshold depression (StD)? * Can tDCS enhance emotional regulation compared to a sham stimulation (placebo)?
Researchers will compare participants receiving tDCS on either the left dorsolateral prefrontal cortex (lDLPFC) or right ventrolateral prefrontal cortex (rVLPFC) with those receiving sham stimulation to see if tDCS has a stronger effect on emotional functions.
Participants will:
* Complete online and in-person screening to assess depressive symptoms using the Chinese version of the Beck Depression Inventory II (C-BDI-II) and be selected based on their depressive symptoms (C-BDI-II score ≥ 13). * Be randomly assigned to one of three groups: lDLPFC tDCS, rVLPFC tDCS, or Sham control group (1:1:1 ratio). * Receive 10 sessions of tDCS or Sham tDCS over 2 weeks, with each session lasting 20 minutes. * Complete assessments at baseline, post-intervention, 1-month follow-up, and 3-month follow-up, with each assessment lasting 2-2.5 hours. This includes questionnaires and perform emotional and cognitive tasks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-35 years
Fluency in Cantonese or Mandarin
Normal or corrected-to-normal vision and hearing
IQ > 75% Quantile in Raven's SPM
Disqualifiers
Past or current major physical illness or psychiatric disorders
Use of psychotropic medication in the past 6 months
Pregnancy (for women)
Any condition that prevents safe tDCS use (e.g., brain injury, implants)
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Direct Current Stimulation
DeviceTDCS is a non-invasive, safe, inexpensive, convenient and effective method to modulate brain and emotion functions. During tDCS, a mild electric current is passed between the anodal and cathodal electrodes on the scalp, which respectively excites and inhibits local and downstream neuronal activity, as well as modulating interregional connectivity strength. Compared to other neurostimulation methods such as Transcranial Magnetic Stimulation, tDCS side effects tend to be milder and transient, even if being administered for multiple sessions, making it suitable to be widely applied on clinical and subclinical populations.
Sham tDCS
DeviceThe sham tDCS delivers actual stimulation for 30 seconds only, while providing similar psychological perceptions to participants as the real intervention. Thus, the sham tDCS serves as an active control condition to the tDCS interventions.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: IDLPFC tDCSExperimental treatment 1 intervention
Group B: rVLPFC tDCSExperimental treatment 1 intervention
Group C: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depressive symptoms
The Beck Depression Inventory-II Chinese Version measures change in depressive symptoms. The total score range is 0-63, higher score indicates more severe depressive symptoms.
Time frame
Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)Secondary outcomes
1
Affective trait
The Chinese Affect Scale measures changes in positive and negative affective traits. Both the positive affect and the negative affect subscales have a score range of 0-40, with higher scores indicating higher levels of positive affect trait and negative affect trait respectively.
Time frame
Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)2
Anhedonia severity
The dimensional anhedonia rating scale measures change in anhedonia severity on distinct physical/social domain. The scale comprises four subscales: Hobbies (4 items; score range 0-16), Food/Drink (4 items; score range 0-16), Social Activities (4 items; score range 0-16), and Sensory Experience (5 items; score range 0-20), with higher scores on each subscale indicating less anhedonia severity within the corresponding domain.
Time frame
Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)3
Anhedonia symptoms
The Chapman Physical/Social Anhedonia scales assess change in anhedonia symptoms in physical and social domains. The Chapman Physical Anhedonia Scale consists of 61 true-false items with a total score range of 0-61, and the Chapman Social Anhedonia Scale consists of 40 true-false items with a total score range of 0-40. For both scales, higher scores indicate higher levels of anhedonia.
Time frame
Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)4
Behavioural motivation trait
The Behavioural Activation and Inhibition Scale measures change in reward-driven approaching and punishment-driven avoidance tendencies. The Behavioural Inhibition System scale consists of 7 items with a score range of 7-28, with higher scores indicating higher behavioural inhibition. The Behavioural Activation System scale comprises three subscales: Drive (4 items; score range 4-16), Fun Seeking (4 items; score range 4-16), and Reward Responsiveness (5 items; score range 5-20). Higher scores on each BAS subscale indicate higher levels of behavioural activation within the corresponding domain.
Time frame
Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Research Grants Council, Hong Kong
Collaborator
Source ClinicalTrials.gov