CClinicalTrials.gg
Not yet recruitingNCT06524206Updated Jul 29, 2024

An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era

An interventional study of The Awareness, Courage and Love Intervention in Loneliness, Depression and Anxiety, sponsored by Caritas Institute of Higher Education. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Caritas Institute of Higher Education · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study summary

The purpose of this study is to explore the potential effectiveness of a one-session online Awareness, Courage, and Love intervention for reducing loneliness, depression and anxiety symptoms, and enhancing social connectedness and subjective well-being among older adults. the study also aims to estimate the effect sizes of the Awareness, Courage, and Love intervention.

Read the detailed description

The recruitment process will commence with referrals from local community organizations. Eligible individuals will be provided with detailed information about the study, and informed consent will be obtained from those willing to participate. After the confirmation of participant recruitment, a randomization process will be implemented to ensure the equitable distribution of participants between the intervention and waitlist control groups. An independent researcher will generate computer-generated random codes for group assignment, and these codes will be securely sealed in opaque envelopes. The envelopes will be sequentially numbered, and the randomization process will remain blinded throughout to prevent bias. Participants will be notified via email or text for the details of the condition they are assigned, and their willingness to engage in both the intervention and data collection will be confirmed.

02

Conditions studied

  • Loneliness
  • Depression
  • Anxiety
  • Social Connectedness
  • Subjective Well-being
  • Psychological Intervention
  • Older Adults

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 70 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Caritas Institute of Higher Education is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. aged 60 years or older and dwelling in the community;
  2. able to communicate in Cantonese;
  3. have access to the internet and videoconferencing devices such as a mobile phone;
  4. able to give informed consent to participate.

Exclusion criteria

Exclusion Criteria:

  1. severe emotional distress based on PHQ-4 screening assessment or presenting an imminent suicidal risk;
  2. known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia/significant cognitive impairment;
  3. illiterate;
  4. difficulty in communication.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Awareness, Courage, and Love intervention

    The Awareness, Courage and Love intervention will consist of a single 120-minute online session delivered in a group format via a videoconferencing application (e.g., Zoom). The theme of the session will evolve around "making friends and being seen" to reinforce the appetitive functions of social connection.

    Behavioral: The Awareness, Courage and Love Intervention

  • No intervention
    Waitlist control group

    Waitlist control group will not receive the intervention

Interventions

  • BehavioralThe Awareness, Courage and Love Intervention

    Derived from Functional Analytic Psychotherapy (FAP), the Awareness, Courage, and Love (ACL) Intervention brings the FAP principles to a broader population. In the ACL model, awareness is defined as engaging in mindful awareness of one's self (feelings, needs, values), other individuals, and the context in which interactions are taking place. Courage is defined as engaging in authentic, vulnerable self-disclosures (e.g. struggles, appreciation), and asking for what one wants and needs. Love is defined as providing empathically accurate responsiveness, including provision of safety, validation, and giving the other person what they have asked for when possible.

06

What researchers measure

Primary outcomes

  1. Changes from Baseline on the Inclusion of Others in Self (IOS) at Immediately post-intervention and One-month post-intervention follow-up

    The single-item Inclusion of Others in the Self (IOS) scale is to measure how close the respondent feels with another person or group. Respondents choose a pair of photos from seven with different degrees of overlap. Possible scores range from 1 (No overlap) to 7 (Most overlap).

    Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up

Secondary outcomes

  1. Changes from Baseline on the 6-item de Jong Gierveld loneliness scale at Immediately post-intervention and One-month post-intervention follow-up

    The 6-item De Jong Gierveld Loneliness Scale is a reliable and valid measurement instrument for overall, emotional, and social loneliness. The possible range of scores is from 0 (Least lonely) to 6 (Most lonely).

    Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up

  2. Changes from Baseline on the Patient Health Questionnaire (PHQ-9) at Immediately post-intervention and One-month post-intervention follow-up

    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression over the last 2 weeks. The interpretation of total scores ranges from 1-4 (Minimal depression) to 20-27 (Severe depression).

    Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up

  3. Changes from Baseline on the Generalized Anxiety Disorder 2-item (GAD-2) at Immediately post-intervention and One-month post-intervention follow-up

    The GAD-2 is a very brief and easy to perform initial screening tool for generalized anxiety disorder over the last 2 weeks. The possible scores range from 0 to 6. Higher scores are associated with higher levels of anxiety. A score of 3 points or more suggests possible anxiety.

    Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up

  4. Changes from Baseline on The World Health Organisation- Five Well-Being Index (WHO-5) at Immediately post-intervention and One-month post-intervention follow-up

    The WHO-5 is a short self-reported measure of current mental wellbeing. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

    Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up

07

Study locations

1 site
  • Caritas Institute of Higher Education
    Hong Kong, Hong Kong
    • Cheong Yu Chan, Dr · Contact · cy4chan@sfu.edu.hk · 37024525
    • Cheong Yu Chan, Dr · Principal investigator
    • Qi Lu Huang · Sub investigator
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06524206
Lead sponsor
Caritas Institute of Higher Education
Responsible party
Stephen Cheong Yu Chan (Assistant Professor, Caritas Institute of Higher Education) — Principal investigator
First posted
Jul 29, 2024
Start date
Aug 2024 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Jul 29, 2024

Study contacts

Cheong Yu Chan, Dr
Contact
cy4chan@sfu.edu.hk
37024525
Cheong Yu Chan, Dr
principal investigator · Caritas Institute of Higher Education

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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