Clinical trial NCT06521099: A Novel Conditioning Approach to Counter Loneliness in Adults
Official title: A Novel Conditioning Approach to Counter Loneliness in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2024-07-25
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Potential participants will first be invited to complete a loneliness questionnaire online. Lonely adults will then be invited to our laboratory 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 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 at the laboratory. Based on their ratings on the stimuli presented during this phase, stimuli will be selected for the conditioning phase. 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 at our laboratory, 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 at laboratory on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also receive resting-state functional MRI scanning in a 3T MRI scanner.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in perceived valence of social stimuli
timeFrame: From baseline to immediately after; from baseline to 3 months after.
measure: Changes in perceived degree of social engagement of social stimuli
timeFrame: From baseline to immediately after; from baseline to 3 months after.
measure: Changes in perceived frequency of experience of social stimuli
timeFrame: From baseline to immediately after; from baseline to 3 months after.
measure: Changes in self-reported loneliness
timeFrame: From baseline to immediately after; from baseline to 3 months after.
measure: Changes in depressive symptoms
timeFrame: From baseline to immediately after; from baseline to 3 months after.
measure: Changes in loneliness-related activation patterns and connectivity in neural networks
timeFrame: From baseline to immediately after; from baseline to 3 months after.
Secondary outcomes:
measure: Changes in daily loneliness
timeFrame: Through study completion, on average of 4 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: Education University of Hong Kong
name: Nichol ML Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: