Clinical trial NCT06719843: Acceptance and Commitment Therapy-based Intervention for Loneliness Among Older Adults Living Alone
Official title: Effectiveness of an Acceptance and Commitment Therapy-based Intervention in Reducing Loneliness Among Older Adults Living Alone: a Cluster-randomised Wait-list Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Loneliness
Keywords: Loneliness
Older adults
Acceptance and committment therapy-based intervention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Salvation Army, Hong Kong and Macau Command
First posted: 2024-12-06
Enrollment: 234
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list trial
Primary purpose: TREATMENT

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.

Detailed description: A convenience sample of 234 older adults living alone will be recruited from six participating community centres (39 participants from each centre). Eligible older adults will be randomly assigned to a waitlist control group (n = 117) or an intervention group (n = 117). Both groups will receive usual community support services. The intervention group will additionally receive four weekly face-to-face ACT-based intervention sessions (approximately 90 minutes each) in group format (each group consisting of six to eight older adults).

The primary outcome (loneliness) and secondary outcomes (psychological flexibility, psychological distress, health-related quality of life, and healthcare utilisation) will be assessed at baseline (T0), immediately post-intervention (T1), 3 months post-intervention (T2) and 6 months post-intervention (T3), using validated questionnaires. A purposive subsample of 36 intervention group participants will be invited for focus group interviews. A generalised estimating equation model with intention-to-treat and path analyses will be used to analyse the quantitative data, whereas thematic analysis will be used for the qualitative data.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Loneliness
timeFrame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention
Secondary outcomes:
measure: Psychological flexibility
timeFrame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention
measure: Psychological distress
timeFrame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention
measure: Health-related quality of life
timeFrame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention
measure: Healthcare utilisation
timeFrame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention
measure: Experiences and perceptions of older adults in intervention group
timeFrame: Assessed within 1 day (T1) after the intervention
Other outcomes:
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