LonelinessNCT06524206
An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era
A study testing The Awareness, Courage and Love Intervention in people with Loneliness and Depression, run by Caritas Institute of Higher Education at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Depression, Anxiety
- What is being tested?
- The Awareness, Courage and Love Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60 years or older and dwelling in the community;
- able to communicate in Cantonese;
- have access to the internet and videoconferencing devices such as a mobile phone;
- able to give informed consent to participate.
Who cannot join
- severe emotional distress based on PHQ-4 screening assessment or presenting an imminent suicidal risk;
- known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia/significant cognitive impairment;
- illiterate;
- difficulty in communication.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Caritas Institute of Higher Education
Hong Kong
Cheong Yu Chan, Dr, 37024525, cy4chan@sfu.edu.hk
Cheong Yu Chan, Dr
About this study
Official title: An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era: A Pilot Randomised Controlled Trial
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.
- Conditions
- Loneliness, Depression, Anxiety, Social Connectedness, Subjective Well-being, Psychological Intervention
- Being tested
- The Awareness, Courage and Love Intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Awareness, Courage and Love InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Awareness, Courage, and Love intervention | Experimental | 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. Receives: Behavioral: The Awareness, Courage and Love Intervention |
| Waitlist control group | No intervention | Waitlist control group will not receive the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Immediately post-intervention and One-month post-intervention follow-up
Secondary outcomes (4)
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).
Measured: Baseline, Immediately post-intervention and One-month post-intervention follow-up
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).
Measured: Baseline, Immediately post-intervention and One-month post-intervention follow-up
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.
Measured: Baseline, Immediately post-intervention and One-month post-intervention follow-up
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.
Measured: Baseline, Immediately post-intervention and One-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caritas Institute of Higher Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Cheong Yu Chan, Caritas Institute of Higher Education
- Investigators
- Cheong Yu Chan, Dr, Principal investigator, Caritas Institute of Higher Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524206
- Sponsor's protocol ID
- CIHE
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06524206
- Acronym / sponsor ID
- CIHE
- Conditions
- Loneliness, Depression, Anxiety, Social Connectedness, Subjective Well-being, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Caritas Institute of Higher EducationUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awareness, Courage, and Love intervention | Experimental | Behavioral: The Awareness, Courage and Love InterventionThe 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. |
| Waitlist control group | No intervention | –Waitlist control group will not receive the intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 60 years or older and dwelling in the community;
- able to communicate in Cantonese;
- have access to the internet and videoconferencing devices such as a mobile phone;
- able to give informed consent to participate.
Key exclusion criteria (4 listed)
- severe emotional distress based on PHQ-4 screening assessment or presenting an imminent suicidal risk;
- known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia/significant cognitive impairment;
- illiterate;
- difficulty in communication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Awareness, Courage and Love InterventionDerived 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. | Behavioural | Awareness, Courage, and Love intervention |
Primary outcome
Changes from Baseline on the Inclusion of Others in Self (IOS) at Immediately post-intervention and One-month post-intervention follow-up
Time frame: Baseline, 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).
4 secondary outcomes
Changes from Baseline on the 6-item de Jong Gierveld loneliness scale at Immediately post-intervention and One-month post-intervention follow-up
Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
Changes from Baseline on the Patient Health Questionnaire (PHQ-9) at Immediately post-intervention and One-month post-intervention follow-up
Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
Changes from Baseline on the Generalized Anxiety Disorder 2-item (GAD-2) at Immediately post-intervention and One-month post-intervention follow-up
Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
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
Time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheong Yu Chan, Dr principal investigator
Caritas Institute of Higher Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Awareness, Courage and Love Intervention in people with Loneliness and Depression, run by Caritas Institute of Higher Education at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheong Yu Chan, Dr (37024525, cy4chan@sfu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline on the Inclusion of Others in Self (IOS) at Immediately post-intervention and One-month post-intervention follow-up (time frame: Baseline, Immediately post-intervention and One-month post-intervention follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.