Treating Loneliness In The Older Adult With Depression With tDCS

October 23, 2024 updated by: Kangguang Lin, Guangzhou Psychiatric Hospital

Effects of Transcranial Direct Current Stimulation on Loneliness in Older Adults With Depression: A Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Loneliness is a pervasive issue among older adults, significantly increasing the risk of major depression and contributing to low recovery rates in affected individuals. Despite its widespread impact, current interventions aimed at alleviating loneliness remain limited and often ineffective. Research has revealed a strong connection between feelings of loneliness, negative social emotions, and decreased resting-state functional connectivity in key brain regions, particularly the lateral prefrontal cortex (LPFC) and the default mode network (DMN). These findings suggest that the neural underpinnings of loneliness may be targeted to improve emotional well-being.

Transcranial direct current stimulation (tDCS) emerges as a promising intervention in this context, as it has been shown to enhance emotional regulation and improve functional connectivity within these neural networks. By applying low electrical currents to specific brain areas, tDCS may help mitigate feelings of loneliness, thereby fostering a greater sense of social connection among older adults with depression.

Objectives Evaluate the Effects of Repeated tDCS on Loneliness Levels: This trial aims to systematically assess how repeated sessions of tDCS influence loneliness in older adults with major depressive disorder. By comparing these groups, we hope to understand the differential impacts of tDCS on loneliness, taking into account the potential confounding effects of depression.

Elucidate the Neuro-Emotional Mechanisms: A key objective is to uncover the neuro-emotional mechanisms that underlie the effects of tDCS on loneliness. This involves examining changes in neural activity and connectivity patterns in the LPFC and DMN, as well as tracking shifts in negative social emotions that may accompany improvements in loneliness. Understanding these mechanisms could enhance the efficacy of tDCS as an intervention.

Develop Predictive Models for Individualized Treatment Outcomes: Another important aim of this trial is to create predictive models that utilize neuro-emotional data to tailor treatment approaches for individuals. By identifying specific neural and emotional markers that correlate with positive outcomes from tDCS, we can move toward more personalized interventions, potentially improving recovery rates and overall mental health in older adults with depression facing loneliness.

This trial represents a significant step toward addressing the critical issue of loneliness in older adults with depression, with the potential to offer a novel and effective intervention strategy that integrates neurobiology and emotional health.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510370
        • Recruiting
        • Guangzhou Brain Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left DLPFC stimulation group
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
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).
Experimental: Right VLPFC stimulation group
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
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 Comparator: Sham stimulation group
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
The electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Emotional and Motivational Ratings from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
Participants' emotional and motivational responses will be assessed using a word rating task, which evaluates how different words or stimuli evoke emotional and motivational reactions.
2 weeks, 1.5 months and 3.5 months
changes in Social Participation Levels from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
The PM-3D4D questionnaire will be utilized to assess participants' levels of social participation, focusing on engagement in social activities and interactions.
2 weeks, 1.5 months and 3.5 months
changes in Social Motivation from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
Social motivation will be evaluated through the Social Motivation Questionnaire, which examines the intrinsic and extrinsic factors that drive social engagement in individuals.
2 weeks, 1.5 months and 3.5 months
changes in Social Network from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
The Lubben Social Network Scale will be used to assess participants' social networks
2 weeks, 1.5 months and 3.5 months
changes in Emotional Regulation from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
The Cognitive Emotion Regulation Questionnaire will be used to assess participants' emotion regulation functions.
2 weeks, 1.5 months and 3.5 months
changes in Affective Traits from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
Affective traits will be evaluated using the Chinese Affect Scale, which assess individual differences in emotional experiences and behavioral tendencies.
2 weeks, 1.5 months and 3.5 months
changes in Reward Sensitivity from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
The Temporal Experience of Pleasure Scale will be used to assess participants' reward sensitivity.
2 weeks, 1.5 months and 3.5 months
changes in Depressive Symptoms from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
Hamilton Depression Rating Scale (HAM-D) will be employed to measure the severity of depressive symptoms among participants, providing insight into their mental health status.
2 weeks, 1.5 months and 3.5 months
changes in Resting-State Functional Connectivity from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
Resting State Functional Connectivity among major brain networks based on T2-weighted functional magnetic resonance imaging data will be assessed.
2 weeks, 1.5 months and 3.5 months
Change in social support from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
the Multidimensional Scale of Perceived Social Support will be used to assess participants' perceived social support
2 weeks, 1.5 months and 3.5 months
changes in Emotion Coping from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
The COPE questionnaire will be used to assess participants' emotion coping under adversity.
2 weeks, 1.5 months and 3.5 months
changes in Incentive-Driven Behavioural Tendencies from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
The Behavioural Activation/Inhibition Scale will be used to assess participants' behavioural tendencies driven by rewards and punishments.
2 weeks, 1.5 months and 3.5 months
changes in Anhedonia level from baseline
Time Frame: 2 weeks, 1.5 months and 3.5 months
The Dimensional Anhedonia Rating Scale will be used to assess participants' anhedonia level.
2 weeks, 1.5 months and 3.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Psychiatric Hospital

Collaborators

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 29, 2024

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-17 (Other Identifier: Chinese PLA general hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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