NCT06524206

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 22, 2024

Last Update Submit

July 26, 2024

Conditions

Outcome Measures

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).

    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

    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

    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

    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

    Baseline, Immediately post-intervention and One-month post-intervention follow-up

Study Arms (2)

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.

Behavioral: The Awareness, Courage and Love Intervention

Waitlist control group

NO INTERVENTION

Waitlist control group will not receive the intervention

Interventions

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.

Awareness, Courage, and Love intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caritas Institute of Higher Education

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Cheong Yu Chan, Dr

    Caritas Institute of Higher Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheong Yu Chan, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 29, 2024

Study Start

August 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations