A Novel Conditioning Approach to Counter Loneliness in Adults

September 9, 2026 updated by: WONG Man Lok Nichol, Education University of Hong Kong
This study aims to test the efficacy of a 6-session conditioning paradigm by investigating the conditioning-induced change in the socio-affective processing, loneliness, depressive symptoms, and neural correlates of lonely adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Potential participants will first be invited to complete a loneliness questionnaire online. Lonely adults will then be invited to undergo further screening. At baseline prior to the intervention training sessions, participants will first complete tests and questionnaires on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also be invited to receive resting-state functional MRI scanning in a 3T MRI scanner. Participants will then be allocated to one of the two intervention arms (the evaluative conditioning, and the control) in a randomized fashion with approximately half in each group. They will then complete the pre-conditioning phase of the allocated intervention arm, and their ratings on the stimuli presented during this phase will be assessed. In the conditioning phase, they will be invited to attend 6 sessions. After completing the conditioning phase, participants will be invited to complete the post- conditioning phase, providing ratings on the stimuli like the pre-conditioning phase. Immediately after, and also 3 months after, participants will be invited to complete again tests and questionnaires on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also be invited to receive resting-state functional MRI scanning in a 3T MRI scanner.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • No histories of learning impairment, major psychiatric disorders or neurological disorders other than depression
  • Normal intelligence
  • At least primary school education

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

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Evaluative conditioning group with positive stimuli
Participants will be exposed to social stimuli paired with positive stimuli across multiple sessions.
Behavioral: Evaluative Conditioning with positive stimuli
In the pre-conditioning phase, participants will be exposed to pictures that vary in their emotional (negative, positive) and social (non-social, social) content. For each picture, they are required to indicate their immediate perceived valence (between negative to positive), degree of social motivation (between none to high) on Likert-scales. In the conditioning phase, emotional social pictures will be selected and paired with non-social positive stimuli for trials in random order, for 6 sessions across 3 weeks. In the post-conditioning phase, participants will be asked to evaluate the valence of the stimuli again similar to that in pre-conditioning phase.
Active Comparator: Control group with neutral stimuli
Participants will be exposed to social stimuli paired with neutral stimuli across multiple sessions.
Behavioral: Conditioning with neutral stimuli
In the pre-conditioning phase, participants will be exposed to pictures that vary in their emotional (negative, positive) and social (non-social, social) content. For each picture, they are required to indicate their immediate perceived valence (between negative to positive), degree of social motivation (between none to high) on Likert-scales. In the conditioning phase, emotional social pictures will be selected and paired with with neutral non-social stimuli for trials in random order, for 6 sessions across 3 weeks. In the post-conditioning phase, participants will be asked to evaluate the valence of the stimuli again similar to that in pre-conditioning phase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported loneliness
Time Frame: Baseline, immediately after, and 3 months after the intervention
Loneliness is assessed based on the UCLA loneliness scale (Version 3), a 20-item 4-point Likert scale (score range 20 - 80) in which higher scores indicate greater degrees of loneliness.
Baseline, immediately after, and 3 months after the intervention
Implicit loneliness
Time Frame: Baseline, immediately after, and 3 months after the intervention
Implicit loneliness will be measured by Implicit Association Test about the relative strength of association between our participants' target concept 'Self' and attribute 'Lonely'.
Baseline, immediately after, and 3 months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Valence of social stimuli
Time Frame: Baseline, immediately after, and 3 months after the intervention
For each stimuli, they are required to indicate their immediate perceived valence (between negative to positive) of the scenes on a 7-point Likert scale (1 = strongly positive, 7 = strongly negative).
Baseline, immediately after, and 3 months after the intervention
Social motivation towards social stimuli
Time Frame: Baseline, immediately after, and 3 months after the intervention
For each stimuli, they are required to indicate their immediate perceived degree of social motivation (between none to high) of the scenes on a 7-point Likert scales (1 = no, 7 = very high).
Baseline, immediately after, and 3 months after the intervention
Loneliness-related activation patterns and connectivity in neural networks
Time Frame: Baseline, immediately after, and 3 months after the intervention
Neural connectivity in Default Mode Network, Ventral Attention Network, Frontoparietal Network are assessed by fMRI
Baseline, immediately after, and 3 months after the intervention
Depressive symptoms
Time Frame: Baseline, immediately after, and 3 months after the intervention
Depressive symptoms are assessed based on the Hospital Anxiety and Depression Scale, a 14-item scale assessing severity of depressive and anxiety symptom (score range 0 - 21 for both subscale), with higher scores indicating higher severity
Baseline, immediately after, and 3 months after the intervention
Daily loneliness
Time Frame: Through study completion, on average of 4 months
Daily loneliness is assessed based on a 5-minute self-report on a Likert scale
Through study completion, on average of 4 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Education University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nichol ML Wong, PhD, Education 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2022-2023-0082

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

product manufactured in and exported from the U.S.

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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