Major Depressive DisorderNCT06658795
Treating Loneliness In The Older Adult With Depression With tDCS
A study testing Transcranial direct current stimulation (tDCS) on the Left DLPFC and Transcranial direct current stimulation (tDCS) on the right VLPFC in people with Major Depressive Disorder and Loneliness, run by Guangzhou Psychiatric Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Loneliness
- What is being tested?
- Transcranial direct current stimulation (tDCS) on the Left DLPFC and Transcranial direct current stimulation (tDCS) on the right VLPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robin Shao, PhD contact
China1 site, 1 recruiting
- Recruiting
Guangzhou Brain Hospital
Guangzhou, Guangdong, 510370
Kangguang Lin, Ph.D; MD, 8602081268219, linkangguang@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder, Loneliness
- Being tested
- Transcranial direct current stimulation (tDCS) on the Left DLPFC, Transcranial direct current stimulation (tDCS) on the right VLPFC, Sham stimulation group
- Keywords
- Randomization Controlled Trial, Transcranial Direct Current Stimulation, Depression, loneliness
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS) on the Left DLPFCDevice
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 VLPFCDevice
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 groupDevice
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: 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. Receives: Device: Sham stimulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks, 1.5 months and 3.5 months
Secondary outcomes (13)
Change in Emotional and Motivational Ratings from baseline
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.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Social Participation Levels from baseline
The PM-3D4D questionnaire will be utilized to assess participants' levels of social participation, focusing on engagement in social activities and interactions.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Social Motivation from baseline
Social motivation will be evaluated through the Social Motivation Questionnaire, which examines the intrinsic and extrinsic factors that drive social engagement in individuals.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Social Network from baseline
The Lubben Social Network Scale will be used to assess participants' social networks
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Emotional Regulation from baseline
The Cognitive Emotion Regulation Questionnaire will be used to assess participants' emotion regulation functions.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Affective Traits from baseline
Affective traits will be evaluated using the Chinese Affect Scale, which assess individual differences in emotional experiences and behavioral tendencies.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Reward Sensitivity from baseline
The Temporal Experience of Pleasure Scale will be used to assess participants' reward sensitivity.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Depressive Symptoms from baseline
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.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Resting-State Functional Connectivity from baseline
Resting State Functional Connectivity among major brain networks based on T2-weighted functional magnetic resonance imaging data will be assessed.
Measured: 2 weeks, 1.5 months and 3.5 months
Change in social support from baseline
the Multidimensional Scale of Perceived Social Support will be used to assess participants' perceived social support
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Emotion Coping from baseline
The COPE questionnaire will be used to assess participants' emotion coping under adversity.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Incentive-Driven Behavioural Tendencies from baseline
The Behavioural Activation/Inhibition Scale will be used to assess participants' behavioural tendencies driven by rewards and punishments.
Measured: 2 weeks, 1.5 months and 3.5 months
changes in Anhedonia level from baseline
The Dimensional Anhedonia Rating Scale will be used to assess participants' anhedonia level.
Measured: 2 weeks, 1.5 months and 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start29 Oct 2024 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Kangguang Lin, Guangzhou Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658795
- Sponsor's protocol ID
- 2024-17
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33549516He 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.
PubMed 31615594
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Loneliness in Older Adults With Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06658795
- Acronym / sponsor ID
- 2024-17
- Conditions
- Major Depressive Disorder, Loneliness
- Keywords
- Randomization Controlled Trial, Transcranial Direct Current Stimulation, Depression, loneliness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Collaborators
- The University of Hong Kong
- Study start
- 29 Oct 2024 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Left DLPFC stimulation group | Experimental | Device: Transcranial direct current stimulation (tDCS) on the Left DLPFCThe 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) |
| Right VLPFC stimulation group | Experimental | Device: Transcranial direct current stimulation (tDCS) on the right VLPFCThe 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). |
| Sham stimulation group | Sham comparator | Device: Sham stimulation groupIn 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- Severe neurological diseases.
- Bipolar disorder, schizophrenia, addiction, or impulse control disorders.
- Contraindications for tDCS or MRI (e.g., metal implants).
- Presence of suicidal ideation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (tDCS) on the Left DLPFCThe 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). | Device | Left DLPFC stimulation group |
| Transcranial direct current stimulation (tDCS) on the right VLPFCThe 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) | Device | Right VLPFC stimulation group |
| Sham stimulation groupThe 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 |
Primary outcome
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.
13 secondary outcomes
Change in Emotional and Motivational Ratings from baseline
Time frame: 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
changes in Social Motivation from baseline
Time frame: 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
changes in Emotional Regulation from baseline
Time frame: 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
changes in Reward Sensitivity from baseline
Time frame: 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
changes in Resting-State Functional Connectivity from baseline
Time frame: 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
changes in Emotion Coping from baseline
Time frame: 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
changes in Anhedonia level from baseline
Time frame: 2 weeks, 1.5 months and 3.5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 33549516Dubreuil-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.
- Background: PubMed 31615594He 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin Shao, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) on the Left DLPFC and Transcranial direct current stimulation (tDCS) on the right VLPFC in people with Major Depressive Disorder and Loneliness, run by Guangzhou Psychiatric Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kangguang Lin, PhD; MD (8613560360144, klin@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.