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NCT Number: NCT06521099

A Novel Conditioning Approach to Counter Loneliness in Adults

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.

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Key information

Conditions

Loneliness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluative Conditioning with positive stimuli

Behavioral

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 stimuli

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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'.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nichol ML Wong, PhD

CONTACT

[email protected]

852-29487431

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • The University of Hong Kong

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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