Treating Loneliness In The Older Adult With Depression With tDCS

NCT06658795 | Recruiting DMC

• 1 other identifier: 2024-17
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Loneliness

Keywords

Randomization Controlled Trial; Transcranial Direct Current Stimulation; Depression; loneliness

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks, 1.5 months and 3.5 months

Secondary Outcomes (13)

• Change in Emotional and Motivational Ratings from baseline

  2 weeks, 1.5 months and 3.5 months

• changes in Social Participation Levels from baseline

  2 weeks, 1.5 months and 3.5 months

• changes in Social Motivation from baseline

  2 weeks, 1.5 months and 3.5 months

• changes in Social Network from baseline

  2 weeks, 1.5 months and 3.5 months

• changes in Emotional Regulation from baseline

  2 weeks, 1.5 months and 3.5 months

Study Arms (3)

Left DLPFC stimulation group

EXPERIMENTAL

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 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)

Device: Transcranial direct current stimulation (tDCS) on the Left DLPFC

Right VLPFC stimulation group

EXPERIMENTAL

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 right VLPFC 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).

Device: Transcranial direct current stimulation (tDCS) on the right VLPFC

Sham stimulation group

SHAM COMPARATOR

In the sham stimulation group, the electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.

Device: Sham stimulation group

Interventions

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).

Left DLPFC stimulation group

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)

Right VLPFC stimulation group

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.

Sham stimulation group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Severe neurological diseases.
• Bipolar disorder, schizophrenia, addiction, or impulse control disorders.
• Contraindications for tDCS or MRI (e.g., metal implants).
• Presence of suicidal ideation.

Sponsors & Collaborators

• Guangzhou Psychiatric Hospital: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Guangzhou Brain Hospital

Guangzhou, Guangdong, 510370, China

RECRUITING

Related Publications (2)

• Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10.1016/j.bpsc.2020.11.006. Epub 2020 Nov 25.

  PMID: 33549516 BACKGROUND

• He Z, Liu Z, Zhao J, Elliott R, Zhang D. Improving emotion regulation of social exclusion in depression-prone individuals: a tDCS study targeting right VLPFC. Psychol Med. 2020 Dec;50(16):2768-2779. doi: 10.1017/S0033291719002915. Epub 2019 Oct 16.

  PMID: 31615594 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Kangguang Lin, PhD; MD

CONTACT

8613560360144; klin@gzhmu.edu.cn

Robin Shao, PhD

CONTACT

James0828@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Affective disorders

Model Details: 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) (Figure 1-5a). 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) (Figure 1-5b). In the sham stimulation group, the electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)