Clinical trial NCT06517121: TDCS in People with Subthreshold Depression
Official title: Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People with Subthreshold Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subthreshold Depression
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Chinese University of Hong Kong
First posted: 2024-07-24
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, and they will also receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a total 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 the 10 sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood, and they will also receive functional MRI scanning in the 3T MRI scanner. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.

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

Primary outcomes:
measure: Changes in self-reported loneliness
timeFrame: From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session
measure: Changes in self-reported mood
timeFrame: From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session
measure: Changes in depressive symptoms
timeFrame: From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session
measure: Changes in brain activation and connectivity related to socio-affective processing
timeFrame: From baseline to after the 10th tDCS session (2 weeks); from baseline to 3 months after the last tDCS session
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Education University of Hong Kong
Study officials:
affiliation: Education University of Hong Kong
name: Nichol ML Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: