NCT Number: NCT06719843
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 opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention
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.
Time frame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention
The short form of the Comprehensive assessment of Acceptance and Commitment Therapy Processes will be used to measure psychological flexibility. It comprises 10 items measuring openness to experience, behavioural awareness, and valued action. The scores range from 0 to 60. A higher score indicates greater psychological flexibility.
Time frame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention
The Chinese version of the Depression Anxiety Stress Scale (DASS-21) will be used to measure psychological distress. It comprises 21 items measuring depressive, anxiety, and stress symptoms in older adults. A higher score indicates a higher level of psychological distress. The cutoff scores that indicate severe and highly severe depression, anxiety, and stress are >20, >14, and >25, respectively.
Time frame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention
The Chinese (Hong Kong) Short Form-12 version 2 (SF-12v2) will be used to assess health-related quality of life (HRQOL). It comprises 12 items that measure eight domains of quality of life, which are summed into two subscales. The scores range from 0 to 100. A high score indicates good HRQOL.
Time frame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention
It will be assessed based on the number of accident and emergency department visits, outpatient clinic visits (e.g., specialist outpatient clinic, family medicine, general outpatient clinic, and allied health appointments), and inpatient length of stay.
Time frame: Assessed within 1 day (T1) after the intervention
Focus group interviews will be conducted to explore the experiences and perceptions of older adults in intervention group regarding their participation in ACT-based interventions and the impact of the intervention on their loneliness using an interview guide.
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
Effectiveness of an Acceptance and Commitment Therapy-based Intervention in Reducing Loneliness Among Older Adults Living Alone: a Cluster-randomised Wait-list Controlled Trial
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