A Novel Conditioning Approach to Counter Loneliness in Adults

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 sessio
• Поведенческое 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 se

Первичные конечные точки

• Self-reported loneliness [Срок оценки: Baseline, immediately after, and 3 months after the intervention]
• Implicit loneliness [Срок оценки: Baseline, immediately after, and 3 months after the intervention]

Вторичные конечные точки (5)

• Valence of social stimuli [Срок оценки: Baseline, immediately after, and 3 months after the intervention]
• Social motivation towards social stimuli [Срок оценки: Baseline, immediately after, and 3 months after the intervention]
• Loneliness-related activation patterns and connectivity in neural networks [Срок оценки: Baseline, immediately after, and 3 months after the intervention]
• Depressive symptoms [Срок оценки: Baseline, immediately after, and 3 months after the intervention]
• Daily loneliness [Срок оценки: Through study completion, on average of 4 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The University of Hong Kong — Гонконг

Публикации

• 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. PMID 40866945

Идентификаторы

NCT: NCT06521099 · E2022-2023-0082

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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