- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07288671
Nostalgia Intervention on Alleviating Loneliness Amongst Older Adults
Effects of a Nostalgia Intervention on Alleviating Loneliness Amongst Community-dwelling Older Adults: A Cluster-randomised Waitlist-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A convenience sample of 294 older adults from six participating community centres, with 49 participants from each centre. Eligible older adults will be randomly assigned to either a waitlist control group (n = 147) or an intervention group (n = 147). Both groups will receive standard community support services, whilst the intervention group will also participate in five weekly face-to-face nostalgia sessions (approximately 90 min each) in a group format. Additionally, a purposive subsample of 30 participants from the intervention group will be invited for focus group interviews.
The primary outcome (loneliness) and secondary outcomes will be assessed at baseline (T0), immediately post-intervention (T1), 3 months post-intervention (T2) and 6 months post-intervention (T3) using validated questionnaires. The investigators will analyse the quantitative data using a generalised estimating equation model with intention-to-treat and path analyses. The qualitative data will be analysed using reflexive thematic analysis. The findings of this proposed study will inform healthcare professionals and policymakers, offering practical strategies to combat loneliness in this vulnerable group.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cho Lee Wong, PhD
- Phone Number: +852 39438166
- Email: jojowong@cuhk.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- older adults aged 60 years or above
- residing in the community
- capable of speaking and understanding Chinese
- experiencing loneliness (scoring ≥3 on a three-item loneliness screening scale)
Exclusion Criteria:
- currently undergoing psychological intervention
- having a clinical diagnosis of mental illness
- being cognitively impaired (Abbreviated Mental Test score <6)
- having visual/language/communication difficulties
Study Plan
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: Experimental: Nostalgia intervention
In addition to usual community support services, participants in the intervention group will receive the face-to-face nostalgia intervention weekly for 5 weeks (each session lasting approximately 90 minutes), with each group consisting of 5-8 older adults.
|
Participants in the intervention group will receive the face-to-face nostalgia intervention weekly for 5 weeks (each session lasting approximately 90 minutes), with each group consisting of 5-8 older adults.
The intervention consists of 5 sessions: Session 1 (understanding nostalgia and its benefits), Session 2-4 (music/ photos/ meaningful objects and nostalgia), Session 5 (reaffirming the benefits of nostalgia).
|
|
No Intervention: Wait-list control
Participants in the wait-list control group will receive usual community support services provided by the community centres they belong to.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional and social loneliness
Time Frame: Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
The Chinese version of the De Jong Gierveld Loneliness Scale.
This six-item scale scores range from 0 to 6, with higher score indicates higher level of loneliness.
This scale demonstrates good internal consistency (Cronbach's α = 0.76) and inter-rater reliability (ICC = 0.98-1.00),
as well as a strong correlation with direct assessments of loneliness.
|
Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
|
Existential Loneliness
Time Frame: Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
Existential Loneliness Questionnaire, which comprises 22 items focused on loneliness in social ties, loneliness in close relationships and the search for meaning in life.
The scores range from 22 to 132, higher scores indicate higher level of existential loneliness.
The questionnaire also demonstrates good internal consistency (Cronbach's α = 0.90).
|
Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experiences and perceptions of older adults in intervention group
Time Frame: Assessed within 1 day (T1) after the intervention
|
Focus group interviews will be conducted to explore the experiences and perceptions of older adults in intervention group regarding their participation in nostalgia interventions and the impact of the intervention on their loneliness using an interview guide.
|
Assessed within 1 day (T1) after the intervention
|
|
Negative emotions
Time Frame: Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention.
|
The Chinese version of the Depression Anxiety Stress Scale consists of 21 items that assess symptoms of depression (7 items), anxiety (7 items), and stress (7 items).
Each subscale scores range from 0 to 21, with higher scores indicating greater levels of negative emotions.
The Chinese version demonstrates good internal consistency (Cronbach's α = 0.92 to 0.94).
|
Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention.
|
|
Social connectedness
Time Frame: Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
The revised Social Connectedness Scale to measure the perceived connection of participants to others in their social environment.
This scale comprises 20 items measuring four aspects: belongingness, closeness, support and satisfaction.
The scores range from 20 to 120, higher scores indicate greater feelings of social connectedness.
This scale demonstrates good internal consistency (Cronbach's α = 0.92) and validity.
|
Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
|
Meaning in life
Time Frame: Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention.
|
Meaning in Life Questionnaire, which comprises 10 items measuring presence for and search for meaning in life, to measure meaning in life.
The score ranges from 10 to 70, higher scores indicates stronger sense of meaning in life.
The Chinese version demonstrates good internal consistency (Cronbach's α = 0.85).
|
Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention.
|
|
Nostalgia
Time Frame: Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
The Southampton Nostalgia Scale to measure participants' nostalgia.
This scale comprises five items that measure the importance participants attribute to nostalgia and two items related to frequency of nostalgia.
The scores range from 7 to 49, higher scores indicate a greater dispositional tendency toward nostalgia.
This scale demonstrates good internal consistency (Cronbach's α = 0.93).
|
Asessed at baseline (T0), immediate after (T1), 3 months (T2), and 6 months (T3) post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cho Lee Wong, PhD, The Nethersole School of Nursing, CUHK
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025.020-T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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