Behavioral Activation and Mindfulness Interventions in Reducing Loneliness and Improving Well-Being in Older Adults: The HEAL-HOA Randomized Clinical Trial.

Importance: Late-life loneliness is a serious public health concern, yet the long-term efficacy and mechanisms of interventions to alleviate it remain underexplored. Objective: To evaluate the 12-month effectiveness of lay counselor-delivered, telephone-based behavioral activation and mindfulness interventions in reducing loneliness and enhancing well-being among at-risk older adults and to examine whether social isolation mediates these effects. Design, Setting, and Participants: The Helping Alleviate Loneliness in Hong Kong Older Adults (HEAL-HOA) was a 3-arm, assessor-blinded randomized clinical trial conducted from April 1, 2021, to April 28, 2024. Eligible participants 65 years or older who were living alone, digitally excluded, lonely, and experiencing financial hardship were recruited from public housing estates, community centers, academies for older adults, and word of mouth. Participants were randomized 1:1:1 to receive telephone-delivered behavioral activation (Tele-BA), telephone-delivered mindfulness (Tele-MF), or telephone-delivered befriending (Tele-BF [attention control]). Interventions: Participants received eight 30-minute sessions delivered by trained lay counselors via telephone for 4 weeks. Main Outcomes and Measures: The primary outcome was loneliness, measured using the UCLA Loneliness Scale (UCLA-LS) and the De Jong Gierveld Loneliness Scale (DJGL). Secondary outcomes included perceived stress, social support, sleep quality, life satisfaction, anxiety, depressive symptoms, and psychological well-being. Social isolation was examined as a mediator. Outcomes were assessed at baseline and at 1, 3, 6, and 12 months of follow-up. Results: Of 4152 individuals screened, 1151 participants (mean [SD] age, 76.6 [7.8] years; 843 [73.2%] female; 965 [83.8%] with ≥1 chronic illness) were randomized (Tele-BA, 335 [29.1%]; Tele-MF, 460 [40.0%]; Tele-BF, 356 [30.9%]). Intention-to-treat analyses using linear mixed-effects models showed significant between-group changes in loneliness at 12 months for Tele-BA (UCLA-LS: mean difference [MD], -0.73; 95% CI, -1.29 to -0.16; P = .01; DJGL: MD, -0.13; 95% CI, -0.23 to -0.03; P = .01) and Tele-MF (UCLA-LS: MD, -0.72; 95% CI, -1.24 to -0.20; P = .003) compared with Tele-BF. Secondary outcomes, including sleep quality, psychological well-being, and life satisfaction, also improved significantly. Social isolation at 6 months partially mediated the effect on loneliness (UCLA-LS) for both interventions at 12 months (accounting for 0.13 [13.5%] and 0.18 [18.0%] of the total effects for Tele-BA and Tele-MF, respectively). Conclusions and Relevance: In this randomized clinical trial, brief telephone-delivered behavioral activation and mindfulness interventions by lay counselors sustainably reduced loneliness and enhanced well-being during 12 months in at-risk older adults, with social isolation as a partial mediator. These scalable interventions offered effective solutions for combating late-life loneliness. Future research should investigate the applicability of these interventions outside the Hong Kong context as well as their cost-effectiveness. Trial Registration: Identifier: ChiCTR2300072909.