Reducing Loneliness Among Older Adults Through Enhancing Positive Affect

Official title

Reducing Loneliness Among Older Adults Through Enhancing Positive Affect: A Randomized Controlled Trial With Ecological Momentary Assessments

Overview

This study aims to evaluate the effectiveness of two psychosocial interventions-Tele-Positive Affect (Tele-PA) and Tele-Behavioral Activation (Tele-BA)-compared to active control (telephone-delivered friendly visit, Tele-FV) in reducing loneliness among older adults in Hong Kong.

Detailed description

Loneliness in older adults represents a critical public health challenge, associated with detrimental outcomes including depression, cardiovascular risks, cognitive decline, and elevated mortality. Despite existing interventions, significant gaps persist: most approaches neglect the affective dimension of loneliness, fail to address the core mechanism of perceived discrepancies between expected and actual social relationships, and inadequately account for age-related shifts in socioemotional goals. This randomized controlled trial addresses these limitations by evaluating two theoretically distinct telephone-delivered psychosocial interventions against an active comparator.

The study employs a three-arm design to compare a 4-week Tele-Positive Affect (Tele-PA) intervention grounded in the broaden-and-build theory of positive emotion, which aims at increasing positive affect through eight evidence-based skills (e.g., gratitude, mindfulness, positive reappraisal), and a Tele-Behavioral Activation (Tele-BA) intervention derived from the behavioral explanations of learning theory, focusing on behavior monitoring and strategies, valued activity scheduling, and social skill enhancement. Both are contrasted with Tele-Friendly Visit (FV)-an active control condition comprising matched-frequency neutral conversations devoid of therapeutic components.

Community-dwelling adults aged ≥65 years in Hong Kong with significant loneliness will be randomized to these arms. Using a three-arm, assessor-blinded randomized clinical trial, outcomes will be measured through retrospective surveys and ecological momentary assessments (EMA) at baseline, immediately post-intervention (Week 2), and at 3- and 6-month follow-ups. Primary analyses will examine: 1) the comparative efficacy of Tele-PA and Tele-BA versus the active control in reducing loneliness; 2) differential effectiveness of Tele-PA versus Tele-BA; 3) the mechanisms underlying the effects of Tele-PA and Tele-BA; and 4) the effects of age on the effectiveness.

This research pioneers the integration of affective science with loneliness intervention design while employing EMA to capture mechanistic dynamics. Findings will advance precision approaches for alleviating loneliness in aging populations through scalable, theory-informed strategies.

Interventions

• Behavioral Tele-Positive Affect Intervention
  A 4-week intervention consisting of eight skills aimed at enhancing positive affect, delivered via telephone by trained facilitators. Participants will learn skills such as gratitude, mindfulness, and positive reappraisal, with sessions held twice a week.
• Behavioral Tele-Behavioral Activation Intervention
  A 4-week intervention designed to promote engagement in meaningful activities, delivered through telephone by trained facilitators. The intervention will include behavior monitoring, activity planning, and social skills enhancement, with sessions held twice a week.
• Behavioral Tele-Friendly Visit
  An active control condition consisting of telephone-delivered friendly visits. Participants will engage in social conversation and activities to provide companionship without any specific skills training aimed at reducing loneliness. The intervention will be held within 4-week.

Primary outcome measures

• Loneliness measured by the UCLA Loneliness Scale [Time frame: Baseline, 3-month, and 6-month]
• Loneliness measured by De Jong Gierveld Loneliness Scale [Time frame: Baseline, 3-month, and 6-month]
• Real-time Experiences on Ecological Momentary Assessment [Time frame: Baseline and 2-week]

Secondary outcome measures (7)

• Psychological Well-being on 6-point Psychological Well-being Scale [Time frame: Baseline, 3-month, and 6-month]
• Perceived Stress on 5-point Chinese Version of the Perceived Stress Scale [Time frame: Baseline, 3-month, and 6-month]
• Symptoms of Depression on 4-point Chinese Version of Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, 3-month, and 6-month]
• Symptoms of Anxiety on 4-point Chinese Version of the Generalized Anxiety Disorder Scale [Time frame: Baseline, 3-month, and 6-month]
• Cognitive Functioning on the Hong Kong Version of Montreal Cognitive Assessment [Time frame: Baseline, 3-month, and 6-month]
• Perceived Social Support on 7-point Multidimensional Scale of Perceived Social Support [Time frame: Baseline, 3-month, and 6-month]
• Social Network on Lubben Social Network Scale at Month 3 and Month 6 [Time frame: Baseline, 3-month, and 6-month]

Eligibility criteria

Inclusion criteria

• aged 65 years or older
• proficiency in Cantonese (over telephone)
• experiencing loneliness (defined as a score of ≥ 6 on the 3-item UCLA Loneliness Scale)

Exclusion criteria

• cognitive impairments
• psychiatric disorders, learning disabilities, or active suicidal ideation
• currently participating in other psychotherapy or psychosocial interventions aimed at enhancing well-being

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Hong Kong · 1 center

• The Education University of Hong Kong — Hong Kong

Publications

• Yu X, Tam WW, Wong PT, Lam TH, Stewart SM. The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry. 2012 Jan;53(1):95-102. doi: 10.1016/j.comppsych.2010.11.002. Epub 2010 Dec 28. PMID 21193179
• Wong A, Xiong YY, Kwan PW, Chan AY, Lam WW, Wang K, Chu WC, Nyenhuis DL, Nasreddine Z, Wong LK, Mok VC. The validity, reliability and clinical utility of the Hong Kong Montreal Cognitive Assessment (HK-MoCA) in patients with cerebral small vessel disease. Dement Geriatr Cogn Disord. 2009;28(1):81-7. doi: 10.1159/000232589. Epub 2009 Aug 11. PMID 19672065
• Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737. PMID 10568646
• Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719. PMID 7473027
• Verstaen A, Moskowitz JT, Snowberg KE, Merrilees J, Dowling GA. Life Enhancing Activities for Family Caregivers of people with dementia: protocol for a randomized controlled trial of a positive affect skills intervention. Open Access J Clin Trials. 2018;10:1-12. doi: 10.2147/oajct.s150597. Epub 2018 Feb 7. PMID 33981167
• Orgeta V, Brede J, Livingston G. Behavioural activation for depression in older people: systematic review and meta-analysis. Br J Psychiatry. 2017 Nov;211(5):274-279. doi: 10.1192/bjp.bp.117.205021. Epub 2017 Oct 5. PMID 28982660
• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. PMID 15817019
• Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21. PMID 22021272

Identifiers

NCT: NCT07021872 · 2023-2024-0179

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗