NCT06719843

Brief Summary

The proposed cluster-randomised wait-list-controlled trial will (1) examine the effects of the acceptance and commitment therapy (ACT)-based intervention on loneliness, psychological flexibility, psychological distress, health-related quality of life, and healthcare utilisation among older adults living alone in Hong Kong; (2) investigate whether the effect of the ACT-based intervention on loneliness is mediated through psychological flexibility; and (3) explore the experiences and perceptions of older adults living alone who participate in ACT-based interventions, including their perceptions of the intervention's impact on their loneliness.

Trial Health

65
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Trial Health Score

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Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2025

Typical duration for not_applicable

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

Study Progress45%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

November 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

2.7 years

First QC Date

November 27, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

LonelinessOlder adultsAcceptance and committment therapy-based intervention

Outcome Measures

Primary Outcomes (1)

  • Loneliness

    The Chinese version of the six-item De Jong Gierveld Loneliness Scale (DJGLS) will be used to measure loneliness. This scale comprises six items measuring emotional and social loneliness. The scores range from 0 to 6, a higher score indicates a greater level of loneliness.

    Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention

Secondary Outcomes (5)

  • Psychological flexibility

    Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention

  • Psychological distress

    Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention

  • Health-related quality of life

    Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention

  • Healthcare utilisation

    Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention

  • Experiences and perceptions of older adults in intervention group

    Assessed within 1 day (T1) after the intervention

Study Arms (2)

ACT-based intervention

EXPERIMENTAL

In addition to usual community support services, participants in the intervention group will receive the face-to-face ACT-based intervention weekly for 4 weeks (each session lasting approximately 90 minutes), with each group consisting of 6-8 older adults.

Behavioral: ACT-based intervention

Wait-list control

NO INTERVENTION

Participants in the wait-list control group will receive usual community support services (e.g. meal delivery) provided by the community centres they belong to.

Interventions

Participants in the intervention group will receive the face-to-face ACT-based intervention weekly for 4 weeks (each session lasting approximately 90 minutes), with each group consisting of 6-8 older adults. The intervention consists of 4 sessions: Session 1 (acceptance and cognitive fusion) Session 2 (contact with the present moment and self-as-context) Session 3 (values) Session 3 (committed action)

ACT-based intervention

Eligibility Criteria

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

You may qualify if:

  • older adults aged 60 years or above
  • residing in the community (living at home without being institutionalised in the past 6 months)
  • capable of speaking and understanding Chinese
  • experiencing loneliness (scoring ≥3 on a three-item loneliness screening scale)
  • living alone for more than 1 year

You may not qualify if:

  • currently undergoing psychological intervention
  • having a clinical diagnosis of mental illness
  • being cognitively impaired (Abbreviated Mental Test score \<6)
  • having visual/language/communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Cho Lee Wong, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Wait-list trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 6, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share