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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Older Adults; Loneliness; Psychological Intervention; Social Connectedness; Subjective Well-being
• Intervention / Treatment: Behavioral: 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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheong Yu Chan, Dr; Phone Number: 37024525; Email: cy4chan@sfu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Caritas Institute of Higher Education
    • Contact: Cheong Yu Chan, Dr; Phone Number: 37024525; Email: cy4chan@sfu.edu.hk
    • Principal Investigator: Cheong Yu Chan, Dr
    • Sub-Investigator: Qi Lu Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
No Intervention: Waitlist control group; Waitlist control group will not receive the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Immediately post-intervention and One-month post-intervention follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.	Baseline, Immediately post-intervention and One-month post-intervention follow-up

Collaborators and Investigators

• Sponsor: Caritas Institute of Higher Education
• Investigators: Principal Investigator: Cheong Yu Chan, Dr, Caritas Institute of Higher Education

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: CIHE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No