LonelinessNCT06521099
A Novel Conditioning Approach to Counter Loneliness in Adults
A study testing Evaluative Conditioning with positive stimuli and Conditioning with neutral stimuli in people with Loneliness, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- Evaluative Conditioning with positive stimuli and Conditioning with neutral stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Aug 2025to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No histories of learning impairment, major psychiatric disorders or neurological disorders other than depression
- Normal intelligence
- At least primary school education
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Nichol ML Wong, PhD, 852-29487431, nmlwong@eduhk.hk
About this study
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.
Read the 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.
- Conditions
- Loneliness
- Being tested
- Evaluative Conditioning with positive stimuli, Conditioning with neutral stimuli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluative Conditioning with positive stimuliBehavioural
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.
Conditioning with neutral stimuliBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluative conditioning group with positive stimuli | Experimental | Participants will be exposed to social stimuli paired with positive stimuli across multiple sessions. Receives: Behavioral: Evaluative Conditioning with positive stimuli |
| Control group with neutral stimuli | Active comparator | Participants will be exposed to social stimuli paired with neutral stimuli across multiple sessions. Receives: Behavioral: Conditioning with neutral stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported loneliness
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.
Measured: Baseline, immediately after, and 3 months after the intervention
Implicit loneliness
Implicit loneliness will be measured by Implicit Association Test about the relative strength of association between our participants' target concept 'Self' and attribute 'Lonely'.
Measured: Baseline, immediately after, and 3 months after the intervention
Secondary outcomes (5)
Valence of social stimuli
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).
Measured: Baseline, immediately after, and 3 months after the intervention
Social motivation towards social stimuli
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).
Measured: Baseline, immediately after, and 3 months after the intervention
Loneliness-related activation patterns and connectivity in neural networks
Neural connectivity in Default Mode Network, Ventral Attention Network, Frontoparietal Network are assessed by fMRI
Measured: Baseline, immediately after, and 3 months after the intervention
Depressive symptoms
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
Measured: Baseline, immediately after, and 3 months after the intervention
Daily loneliness
Daily loneliness is assessed based on a 5-minute self-report on a Likert scale
Measured: Through study completion, on average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start19 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, WONG Man Lok Nichol, Education University of Hong Kong
- Investigators
- Nichol ML Wong, PhD, Principal investigator, Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521099
- Sponsor's protocol ID
- E2022-2023-0082
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong NML, Lee TMC. Evaluating the effects of a conditioning training paradigm on loneliness, socio-affective processing, and brain connectivity: a study protocol of a two-arm randomised controlled trial. BMC Psychol. 2025 Aug 27;13(1):975. doi: 10.1186/s40359-025-03342-3.
PubMed 40866945
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Conditioning Approach to Counter Loneliness in Adults
- ClinicalTrials.gov ID
- NCT06521099
- Acronym / sponsor ID
- E2022-2023-0082
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jul 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluative conditioning group with positive stimuli | Experimental | Behavioral: Evaluative Conditioning with positive stimuliParticipants will be exposed to social stimuli paired with positive stimuli across multiple sessions. |
| Control group with neutral stimuli | Active comparator | Behavioral: Conditioning with neutral stimuliParticipants will be exposed to social stimuli paired with neutral stimuli across multiple sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No histories of learning impairment, major psychiatric disorders or neurological disorders other than depression
- Normal intelligence
- At least primary school education
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Evaluative Conditioning with positive stimuliIn 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. | Behavioural | Evaluative conditioning group with positive stimuli |
| Conditioning with neutral stimuliIn 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. | Behavioural | Control group with neutral stimuli |
Primary outcome
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.
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'.
5 secondary outcomes
Valence of social stimuli
Time frame: 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
Loneliness-related activation patterns and connectivity in neural networks
Time frame: Baseline, immediately after, and 3 months after the intervention
Depressive symptoms
Time frame: Baseline, immediately after, and 3 months after the intervention
Daily loneliness
Time frame: Through study completion, on average of 4 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 10 Sep 2026.
- Derived from this study: PubMed 40866945Wong NML, Lee TMC. Evaluating the effects of a conditioning training paradigm on loneliness, socio-affective processing, and brain connectivity: a study protocol of a two-arm randomised controlled trial. BMC Psychol. 2025 Aug 27;13(1):975. doi: 10.1186/s40359-025-03342-3.
- 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.
Nichol ML Wong, PhD principal investigator
Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluative Conditioning with positive stimuli and Conditioning with neutral stimuli in people with Loneliness, run by Education University of Hong Kong at 1 site in Hong Kong.
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 1 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 10 Sep 2026. 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 Hong Kong. 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. 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 Nichol ML Wong, PhD (852-29487431, nmlwong@eduhk.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported loneliness (time frame: Baseline, immediately after, and 3 months after the intervention). The study lists 2 primary outcomes in all. 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 NCT06521099, which also lists 1 linked publication.
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 10 Sep 2026.