Clinical trial NCT06524206: An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era
Official title: An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Loneliness
Depression
Anxiety
Social Connectedness
Subjective Well-being
Psychological Intervention
Older Adults
Lead sponsor: Caritas Institute of Higher Education
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from Baseline on the Inclusion of Others in Self (IOS) at Immediately post-intervention and One-month post-intervention follow-up
timeFrame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
Secondary outcomes:
measure: Changes from Baseline on the 6-item de Jong Gierveld loneliness scale at Immediately post-intervention and One-month post-intervention follow-up
timeFrame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
measure: Changes from Baseline on the Patient Health Questionnaire (PHQ-9) at Immediately post-intervention and One-month post-intervention follow-up
timeFrame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
measure: Changes from Baseline on the Generalized Anxiety Disorder 2-item (GAD-2) at Immediately post-intervention and One-month post-intervention follow-up
timeFrame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
measure: 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
timeFrame: Baseline, Immediately post-intervention and One-month post-intervention follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Caritas Institute of Higher Education
Study officials:
affiliation: Caritas Institute of Higher Education
name: Cheong Yu Chan, Dr
role: PRINCIPAL_INVESTIGATOR
References: