Acceptance and Commitment Therapy-based Intervention for Loneliness Among Older Adults Living Alone

Not Applicable

Not yet recruiting

• Conditions: Loneliness

• Registration Number: NCT06719843
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Study Start: 2025-01-01
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 234

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Loneliness	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.

Secondary Outcome Measures

Name	Time	Method
Psychological flexibility	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.
Psychological distress	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.
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	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.
Healthcare utilisation	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.
Experiences and perceptions of older adults in intervention group	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.