- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06521099
A Novel Conditioning Approach to Counter Loneliness in Adults
February 27, 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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
136
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
- Name: Nichol ML Wong, PhD
- Phone Number: 852-29487431
- Email: nmlwong@eduhk.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Nichol ML Wong, PhD
- Phone Number: 852-29487431
- Email: nmlwong@eduhk.hk
-
-
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:
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Evaluative conditioning group with positive stimuli
Participants will be exposed to social stimuli paired with positive stimuli across multiple sessions.
|
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.
|
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
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
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.
Collaborators
Investigators
- 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.
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)
August 19, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
July 11, 2024
First Submitted That Met QC Criteria
July 22, 2024
First Posted (Actual)
July 25, 2024
Study Record Updates
Last Update Posted (Actual)
March 2, 2026
Last Update Submitted That Met QC Criteria
February 27, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID 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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