Treating Loneliness In The Older Adult With Depression With tDCS

ConditionsMajor Depressive Disorder Loneliness

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-80

SponsorGuangzhou Psychiatric Hospital

About this trial

High loneliness is prevalent among older adults and is a significant risk factor for major depression and low recovery rates in patients. Current interventions for loneliness are limited. Previous research has demonstrated a link between loneliness, negative social emotions, and reduced resting-state functional connectivity in the lateral prefrontal cortex (LPFC) and the default mode network (DMN). Transcranial direct current stimulation (tDCS) has shown promise in enhancing emotional regulation and connectivity, potentially alleviating loneliness in older adults with depression.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

High loneliness (UCLA Loneliness Scale > 43).

Diagnosis of major depressive disorder confirmed by the Structured Clinical Interview for DSM-5 Disorders.

absence of suicidal ideation (Hamilton Depression Scale item 3 score ≤ 1).

Disqualifiers

Severe neurological diseases.

Bipolar disorder, schizophrenia, addiction, or impulse control disorders.

Contraindications for tDCS or MRI (e.g., metal implants).

Presence of suicidal ideation.

Trial design

Design model

Parallel

Treatments tested in this trial

Transcranial direct current stimulation (tDCS) on the Left DLPFC
Device
The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. For stimulating the lDLPFC, the positive electrode was placed at position F3, and the negative electrode was placed in the right supraorbital area/FP2 (e.g., Dubreuil-Vall et al., 2021, Biol Psychiatry: CNNI).
Transcranial direct current stimulation (tDCS) on the right VLPFC
Device
The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. Based on the EEG 10-20 international system, the positive electrode for stimulating the rVLPFC was placed at position F6, while the negative electrode was placed in the left supraorbital area/FP1 (e.g., He et al., 2020, Psychol Med)
Sham stimulation group
Device
The electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.

Treatment groups

180 Participants

are divided into 3 treatment groups

Group A: Left DLPFC stimulation groupExperimental treatment 1 intervention

Group B: Right VLPFC stimulation groupExperimental treatment 1 intervention

Group C: Sham stimulation groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline

This outcome measures the change in loneliness levels among participants, assessed using the UCLA Loneliness Scale. Evaluations will occur at baseline, 1 month, and 3 months post-intervention (after the two weeks of intervention, the same as below) to determine the effectiveness of the tDCS intervention on reducing feelings of loneliness in patients with depression.

Time frame